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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Multicenter, Proof-of-concept Study to Evaluate a Combined Oral Contraceptive (COC) Containing 30 µg Ethinylestradiol and 150 µg Levonorgestrel Plus 50 mg Dehydroepiandrosterone (DHEA) or Placebo to Counteract Distressing Decreased Sexual Desire Secondary to COC Use

    Summary
    EudraCT number
    		 2020-000716-30
    Trial protocol
    		 HU   BG   PL   CZ   RO  
    Global end of trial date
    10 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jul 2024
    First version publication date
    25 Jul 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RGL-003-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gedeon Richter Plc
    Sponsor organisation address
    Gyömrői út 19-21, Budapest, Hungary, 1103
    Public contact
    Medical Information Scientific Services, Gedeon Richter Plc., +36 1505 7032, medinfo@richter.hu
    Scientific contact
    Balazs Lazar, Gedeon Richter Plc., +36 20 416 2804, RA.ctaRichter@richter.hu
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of DHEA (50 mg daily dose) relative to placebo in women with COC-associated distressing loss of sexual desire (Hypoactive Sexual Desire Disorder (HSDD) secondary to COC use) as measured by Profile of Female Sexual Function (PFSF) Desire domain.
    Protection of trial subjects
    This study was conducted in accordance with current applicable regulations, International Conference on Harmonisation (ICH) guidelines, and local legal requirements. It complies with the ethical principles described in the 18th World Medical Assembly declaration (Declaration of Helsinki, 1964) and amendments of the 29th (Tokyo 1975), 35th (Venice 1983), 41st (Hong Kong 1989) and 48th (South Africa 1996) World Medical Assemblies, to the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 277
    Country: Number of subjects enrolled
    Romania: 46
    Country: Number of subjects enrolled
    Bulgaria: 27
    Country: Number of subjects enrolled
    Czechia: 22
    Country: Number of subjects enrolled
    Hungary: 25
    Worldwide total number of subjects
    397
    EEA total number of subjects
    397
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    397
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 51 sites in Europe and consisted of a 9-week pretreatment period, a 12-week open-label treatment period (Treatment Period 1), a second 12-week double-blind treatment period (Treatment Period 2), and a 1-week follow-up period.

    Pre-assignment
    Screening details
    		 A total of 662 participants were screened of whom 397 enrolled and were treated in Treatment Period 1. A total of 168 qualifying participants continued to Treatment Period 2 and were randomized to double-blind DHEA 50 mg or placebo in a 1:1 ratio.

    Period 1
    Period 1 title
    Treatment Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Combined oral contraceptives (COC)
    Arm description
    		 One COC tablet containing 30 µg ethinylestradiol (EE) and 150 µg levonorgestrel (LNG) was taken orally, once daily, for 21 consecutive days, followed by a 7-day tablet-free interval from Day 22 to Day 28 of each cycle. This 28-day cyclic regimen was taken for 3 cycles in Treatment Period 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    COC tablet
    Investigational medicinal product code
    Other name
    (Oestrogen) Ethinylestradiol and (Progestogen) Levonorgestrel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Taken once daily by mouth, in the morning, and at the same time each day in the order directed on the blister package.

    Number of subjects in period 1
    		Combined oral contraceptives (COC)
    Started
    397
    Completed
    289
    Not completed
    108
         Physician decision
    7
         Consent withdrawn by subject
    36
         Adverse event, non-fatal
    19
         Not specified
    42
         Lost to follow-up
    4
    Period 2
    Period 2 title
    Treatment Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DHEA 50 mg + COC
    Arm description
    		 Eligible participants who completed Treatment Period 1 and qualified at the second baseline (Visit 8) continued to receive COC treatment and were randomized to also receive DHEA during Treatment Period 2. In the second treatment period, one COC tablet containing 30 µg EE and 150 µg LNG was taken on Days 1 to 21, and two 25 mg DHEA tablets were taken on Days 1 to 28 of each 28-day cycle. COC + DHEA were taken together, once daily, in the morning, and with a meal. This 28-day cyclic regimen was to be taken for 3 consecutive cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prasterone
    Investigational medicinal product code
    Other name
    Dehydroepiandrosterone (DHEA)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet of combined 30 µg EE/150 µg LNG and two 25 mg DHEA/placebo tablets were to be taken together once daily, in the morning, with a meal.

    Investigational medicinal product name
    COC tablet
    Investigational medicinal product code
    Other name
    (Oestrogen) Ethinylestradiol and (Progestogen) Levonorgestrel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Taken once daily by mouth, in the morning, and at the same time each day in the order directed on the blister package.

    Arm title
    		 Placebo + COC
    Arm description
    		 Eligible participants who completed Treatment Period 1 and qualified at the second baseline (Visit 8) continued to receive COC treatment and were randomized to also receive placebo during Treatment Period 2. One COC tablet containing 30 µg EE and 150 µg LNG was taken on Days 1 to 21 of each cycle and two matching placebo (DHEA) tablets were taken on Days 1 to 28 of each 28-day cycle. COC +placebo were taken together, once daily, in the morning, and with a meal. This 28-day cyclic regimen was to be taken for 3 consecutive cycles. One participant who was randomised to the placebo + COC arm but was never dosed with the blinded treatment, leading to the exclusion from the Full Analysis Set (FAS) population.
    Arm type
    		 Placebo

    Investigational medicinal product name
    COC tablet
    Investigational medicinal product code
    Other name
    (Oestrogen) Ethinylestradiol and (Progestogen) Levonorgestrel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Taken once daily by mouth, in the morning, and at the same time each day in the order directed on the blister package.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two matching placebo (DHEA) tablets were taken on Days 1 to 28 of each cycle.

    Number of subjects in period 2 [1]
    		DHEA 50 mg + COC Placebo + COC
    Started
    84
    84
    Completed
    68
    67
    Not completed
    16
    17
         Consent withdrawn by subject
    7
    8
         Physician decision
    -
    1
         Failure to meet Continuation criteria
    -
    1
         Adverse event, non-fatal
    3
    3
         Not specified
    3
    2
         Lost to follow-up
    2
    1
         Lack of efficacy
    1
    -
         Not treated
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Of the 289 participants that completed Treatment Period 1, 168 of those participants qualified and were randomized in Treatment Period 2.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period 1
    Reporting group description
    		 One COC tablet containing 30 μg ethinylestradiol (EE) and 150 μg levonorgestrel (LNG) was taken orally, once daily, for 21 consecutive days, followed by a 7-day tablet-free interval from Day 22 to Day 28 of each cycle. This 28-day cyclic regimen was taken for 3 cycles in Treatment Period 1.

    Reporting group values
    		 Treatment Period 1 Total
    Number of subjects
    		 397 397
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 397 397
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 29.0 ( 6.75 ) -
    Gender categorical
    Units: Subjects
        Female
    		 397 397
        Male
    		 0 0
    Race
    Units: Subjects
        Black or African American
    		 1 1
        White
    		 287 287
        Other
    		 109 109

    End points

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    End points reporting groups
    Reporting group title
    Combined oral contraceptives (COC)
    Reporting group description
    		 One COC tablet containing 30 µg ethinylestradiol (EE) and 150 µg levonorgestrel (LNG) was taken orally, once daily, for 21 consecutive days, followed by a 7-day tablet-free interval from Day 22 to Day 28 of each cycle. This 28-day cyclic regimen was taken for 3 cycles in Treatment Period 1.
    Reporting group title
    DHEA 50 mg + COC
    Reporting group description
    		 Eligible participants who completed Treatment Period 1 and qualified at the second baseline (Visit 8) continued to receive COC treatment and were randomized to also receive DHEA during Treatment Period 2. In the second treatment period, one COC tablet containing 30 µg EE and 150 µg LNG was taken on Days 1 to 21, and two 25 mg DHEA tablets were taken on Days 1 to 28 of each 28-day cycle. COC + DHEA were taken together, once daily, in the morning, and with a meal. This 28-day cyclic regimen was to be taken for 3 consecutive cycles.

    Reporting group title
    Placebo + COC
    Reporting group description
    		 Eligible participants who completed Treatment Period 1 and qualified at the second baseline (Visit 8) continued to receive COC treatment and were randomized to also receive placebo during Treatment Period 2. One COC tablet containing 30 µg EE and 150 µg LNG was taken on Days 1 to 21 of each cycle and two matching placebo (DHEA) tablets were taken on Days 1 to 28 of each 28-day cycle. COC +placebo were taken together, once daily, in the morning, and with a meal. This 28-day cyclic regimen was to be taken for 3 consecutive cycles. One participant who was randomised to the placebo + COC arm but was never dosed with the blinded treatment, leading to the exclusion from the Full Analysis Set (FAS) population.

    Primary: Change from Baseline in PFSF Desire Domain at Day 168

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    End point title
    		 Change from Baseline in PFSF Desire Domain at Day 168
    End point description
    The Profile of Female Sexual Function (PFSF) is a questionnaire completed by the participant themselves which assesses the participant’s sexual function over the past 4 weeks. The PFSF has 7 domains one of which is the PFSF Desire Domain consisting of 9 questionnaire items with each item scored from 1 to 6 on a 6-point scale where 1 = “Always” and 6 = “Never". These item scores were then summed into a PFSF Desire domain score which was transformed to a 0-100 point scale where higher scores indicated a more favourable sexual function. FAS: All participants who were randomized to one of the blinded treatment arms and took at least 1 dose of blinded study treatment. Participants were analyzed according to their randomized treatment regardless of the actual treatment received.
    End point type
    Primary
    End point timeframe
    Baseline and Day 168
    End point values
    		 DHEA 50 mg + COC Placebo + COC
    Number of subjects analysed
    84
    83
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 14 (CYCLE 6 DAY 28/EOT) - Day 168;n=65,n=60
    25.470 ( 20.7323 )
    31.371 ( 20.9626 )
    Statistical analysis title
    		 Change from Baseline in PFSF Desire Domain Score
    Statistical analysis description
    Change from Baseline in PFSF Desire Domain Score at Day 168 of treatment period 2.
    Comparison groups
    DHEA 50 mg + COC v Placebo + COC
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0538
    Method
    		 Mixed effect repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.725
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.561
         upper limit
    		 0.112
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.473

    Secondary: Change from Baseline in Female Sexual Distress Scale-Revised (FSDS-R) Item 13 Score at Day 168

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    End point title
    		 Change from Baseline in Female Sexual Distress Scale-Revised (FSDS-R) Item 13 Score at Day 168
    End point description
    The FSDS-R is a questionnaire completed by the participants themselves which assesses distress related to sexuality over the past 30 days. FSDS-R has 13 items, each scored on a 5-point scale, where 0 = “Never” and 4 = “Always”, with higher scores indicating more sexually related distress.  Item 13 specifically asks to what degree participants felt “Bothered by Low Sexual Desire” over the past 30 days. FAS: Consisted of all participants who were randomised to one of the blinded treatment arms and took at least 1 dose of blinded study treatment. Participants were analysed according to their randomised treatment regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 168
    End point values
    		 DHEA 50 mg + COC Placebo + COC
    Number of subjects analysed
    84
    83
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 14 (CYCLE 6 DAY 28/EOT) - Day 168; n=80,n=79
    -1.4 ( 1.40 )
    -1.3 ( 1.31 )
    Statistical analysis title
    		 Change from Baseline in FSDS-R Item 13 Score
    Statistical analysis description
    Change from Baseline in FSDS-R Item 13 Score at Day 168 of treatment period 2.
    Comparison groups
    DHEA 50 mg + COC v Placebo + COC
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8972
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.024
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.348
         upper limit
    		 0.397
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.189

    Secondary: Number of Subjects Answering the Subject’s Meaningful Benefit Question with Yes at Day 168

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    End point title
    		 Number of Subjects Answering the Subject’s Meaningful Benefit Question with Yes at Day 168
    End point description
    Subject’s Meaningful Benefit Question was: “Overall, do you believe you have experienced a meaningful benefit from the study medication?”, to be answered with “Yes/No”. The data were collected per electronic patient-reported outcomes. FAS: Consisted of all participants who were randomised to one of the blinded treatment arms and took at least 1 dose of blinded study treatment. Participants were analysed according to their randomised treatment, regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Day 168
    End point values
    		 DHEA 50 mg + COC Placebo + COC
    Number of subjects analysed
    84
    83
    Units: Count of Subjects
        Responder n=79, n=79
    47
    45
        Non-responder n=79, n=79
    32
    34
    Statistical analysis title
    		 Answering the Patient’s Meaningful Question Yes
    Statistical analysis description
    Analysis Number of Subjects Answering the Patient’s Meaningful Benefit Question as Yes at Day 168 of treatment period 2.
    Comparison groups
    DHEA 50 mg + COC v Placebo + COC
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.747
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 2.089

    Secondary: Change from Baseline in PFSF Responsiveness Domain at Day 168

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    End point title
    		 Change from Baseline in PFSF Responsiveness Domain at Day 168
    End point description
    The PFSF is a questionnaire completed by the participant themselves which assesses the participant’s sexual function over the past 4 weeks. The PFSF has 7 domains one of which is the PFSF Responsiveness Domain consisting of 7 questionnaire items with each item scored from 1 to 6 on a 6-point scale where 1 = “Always” and 6 = “Never". These item scores were then summed into a PFSF Responsiveness domain score which was transformed to a 0-100 point scale where higher scores indicated a more favourable sexual function. FAS: Consisted of all participants who were randomised to one of the blinded treatment arms and took at least 1 dose of blinded study treatment. Participants were analyzed according to their randomized treatment regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 168
    End point values
    		 DHEA 50 mg + COC Placebo + COC
    Number of subjects analysed
    84
    83
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 14 (CYCLE 6 DAY 28/EOT) - Day 168;n=65,n=60
    24.526 ( 20.3094 )
    28.619 ( 17.2985 )
    Statistical analysis title
    		 Change from Baseline in PFSF Responsiveness Domain
    Statistical analysis description
    Analysis of Change from Baseline in PFSF Responsiveness Domain Score at Day 168 of treatment period 2.
    Comparison groups
    DHEA 50 mg + COC v Placebo + COC
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4531
    Method
    		 Mixed effect repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.031
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.368
         upper limit
    		 3.307
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.699

    Secondary: Change from Baseline in PFSF Arousal Domain at Day 168

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    End point title
    		 Change from Baseline in PFSF Arousal Domain at Day 168
    End point description
    The PFSF is a questionnaire completed by the participant themselves which assesses the participant’s sexual function over the past 4 weeks. The PFSF has 7 domains one of which is the PFSF Arousal domain consisting of 3 questionnaire items with each item scored from 1 to 6 on a 6-point scale where 1 = “Always” and 6 = “Never". These item scores were then summed into a PFSF Arousal domain score which was transformed to a 0-100 point scale where higher scores indicated a more favourable sexual function. FAS: Consisted of all participants who were randomised to one of the blinded treatment arms and took at least 1 dose of blinded study treatment. Participants were analyzed according to their randomized treatment regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 168
    End point values
    		 DHEA 50 mg + COC Placebo + COC
    Number of subjects analysed
    84
    83
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 14 (CYCLE 6 DAY 28/EOT) - Day 168;n=65,n=60
    34.359 ( 29.2787 )
    35.889 ( 27.8025 )
    Statistical analysis title
    		 Change from Baseline in PFSF Arousal Domain Score
    Statistical analysis description
    Analysis of Change from Baseline in PFSF Arousal Domain Score at Day 168 of treatment period 2.
    Comparison groups
    DHEA 50 mg + COC v Placebo + COC
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6865
    Method
    		 Mixed effect repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.763
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.354
         upper limit
    		 6.827
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.364

    Secondary: Change from Baseline in PFSF Orgasm Domain at Day 168

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    End point title
    		 Change from Baseline in PFSF Orgasm Domain at Day 168
    End point description
    The PFSF is a questionnaire completed by the participant themselves which assesses the participant’s sexual function over the past 4 weeks. The PFSF has 7 domains one of which is the PFSF Orgasm Domain consisting of 4 questionnaire items with each item scored from 1 to 6 on a 6-point scale where 1 = “Always” and 6 = “Never". These item scores were then summed into a PFSF Orgasm domain score which was transformed to a 0-100 point scale where higher scores indicated a more favourable sexual function. FAS: All participants who were randomized to one of the blinded treatment arms and took at least 1 dose of blinded study treatment. Participants were analyzed according to their randomized treatment regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 168
    End point values
    		 DHEA 50 mg + COC Placebo + COC
    Number of subjects analysed
    84
    83
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 14 (CYCLE 6 DAY 28/EOT) - Day 168;n=65,n=60
    34.0 ( 26.22 )
    32.3 ( 24.29 )
    Statistical analysis title
    		 Change from Baseline in PFSF Orgasm Domain Score
    Statistical analysis description
    Analysis of Change from Baseline in PFSF Orgasm Domain Score at Day 168 of treatment period 2.
    Comparison groups
    DHEA 50 mg + COC v Placebo + COC
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8709
    Method
    		 mixed effect repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.634
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.067
         upper limit
    		 8.335
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.895

    Secondary: Change from Baseline in PFSF Pleasure Domain at Day 168

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    End point title
    		 Change from Baseline in PFSF Pleasure Domain at Day 168
    End point description
    The PFSF is a questionnaire completed by the participant themselves which assesses the participant’s sexual function over the past 4 weeks. The PFSF has 7 domains one of which is the PFSF Pleasure Domain consisting of 7 questionnaire items with each item scored from 1 to 6 on a 6-point scale where 1 = “Always” and 6 = “Never". These item scores were then summed into a PFSF Pleasure domain score which was transformed to a 0-100 point scale where higher scores indicated a more favourable sexual function. FAS: All participants who were randomized to one of the blinded treatment arms and took at least 1 dose of blinded study treatment. Participants were analyzed according to their randomized treatment regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 168
    End point values
    		 DHEA 50 mg + COC Placebo + COC
    Number of subjects analysed
    84
    83
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 14 (CYCLE 6 DAY 28/EOT) - Day 168;n=65,n=60
    31.341 ( 26.5778 )
    32.953 ( 23.4871 )
    Statistical analysis title
    		 Change from Baseline in PFSF Pleasure Domain Score
    Statistical analysis description
    Analysis of Change from Baseline in PFSF Pleasure Domain Score at Day 168 of treatment period 2.
    Comparison groups
    DHEA 50 mg + COC v Placebo + COC
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4721
    Method
    		 Mixed effect repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.968
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.082
         upper limit
    		 5.146
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.121

    Secondary: Change from Baseline in PFSF Concerns Domain at Day 168

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    End point title
    		 Change from Baseline in PFSF Concerns Domain at Day 168
    End point description
    The PFSF is a questionnaire completed by the participant themselves which assesses the participant’s sexual function over the past 4 weeks. The PFSF has 7 domains one of which is the PFSF Concerns Domain consisting of 3 questionnaire items with each item scored from 1 to 6 on a 6-point scale where 1 = “Always” and 6 = “Never". These item scores were then summed into a PFSF Concerns domain score which was transformed to a 0-100 point scale where higher scores indicated a more favourable sexual function. FAS: All participants who were randomized to one of the blinded treatment arms and took at least 1 dose of blinded study treatment. Participants were analyzed according to their randomized treatment regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 168
    End point values
    		 DHEA 50 mg + COC Placebo + COC
    Number of subjects analysed
    84
    83
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 14 (CYCLE 6 DAY 28/EOT) - Day 168;n=65,n=60
    28.615 ( 26.5289 )
    33.778 ( 25.4484 )
    Statistical analysis title
    		 Change from Baseline in PFSF Concerns Domain Score
    Statistical analysis description
    Analysis of Change from Baseline in PFSF Concerns Domain Score at Day 168 of treatment period 2.
    Comparison groups
    Placebo + COC v DHEA 50 mg + COC
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3137
    Method
    		 Mixed effect repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.039
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.918
         upper limit
    		 3.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.001

    Secondary: Change from Baseline in PFSF Self-image Domain at Day 168

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    End point title
    		 Change from Baseline in PFSF Self-image Domain at Day 168
    End point description
    The PFSF is a questionnaire completed by the participant themselves which assesses the participant’s sexual function over the past 4 weeks. The PFSF has 7 domains one of which is the PFSF Self-image Domain consisting of 4 questionnaire items with each item scored from 1 to 6 on a 6-point scale where 1 = “Always” and 6 = “Never". These item scores were then summed into a PFSF Self-image domain score which was transformed to a 0-100 point scale where higher scores indicated a more favourable sexual function. FAS: All participants who were randomized to one of the blinded treatment arms and took at least 1 dose of blinded study treatment. Participants were analyzed according to their randomized treatment regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 168
    End point values
    		 DHEA 50 mg + COC Placebo + COC
    Number of subjects analysed
    84
    83
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 14 (CYCLE 6 DAY 28/EOT) - Day 168;n=65,n=60
    28.6 ( 24.88 )
    34.4 ( 20.79 )
    Statistical analysis title
    		 Change from Baseline in PFSF Self-Image Domain
    Statistical analysis description
    Analysis of Change from Baseline in PFSF Self-Image Domain Score at Day 168 of treatment period 2.
    Comparison groups
    DHEA 50 mg + COC v Placebo + COC
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2115
    Method
    		 Mixed effect repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.713
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.121
         upper limit
    		 2.695
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.763

    Secondary: Change from Baseline in PFSF Total Score at Day 168

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    End point title
    		 Change from Baseline in PFSF Total Score at Day 168
    End point description
    The PFSF is a questionnaire completed by the participant themselves which assesses the participant’s sexual function over the past 4 weeks. The PFSF consists of 37 questionnaire items with each item scored from 1 to 6 on a 6-point scale where 1 = “Always” and 6 = “Never" and an additional global „Satisfaction with Sexuality” item which is scored from 1 to 5 on a 5-point scale where 1 = “Poor” and 5 = “Excellent". These item scores were then summed into a PFSF Total score which was transformed to a 0-100 point scale where higher scores indicated a more favourable sexual function. FAS: All participants who were randomized to one of the blinded treatment arms and took at least 1 dose of blinded study treatment. Participants were analysed according to their randomised treatment, regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 168
    End point values
    		 DHEA 50 mg + COC Placebo + COC
    Number of subjects analysed
    84
    83
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 14 (CYCLE 6 DAY 28/EOT) - Day 168; n=65,n=60
    28.641 ( 20.7389 )
    32.145 ( 18.5014 )
    Statistical analysis title
    		 Change from Baseline in PFSF Total Score
    Statistical analysis description
    Analysis of Change from Baseline in PFSF Total Score at Day 168 of treatment period 2.
    Comparison groups
    Placebo + COC v DHEA 50 mg + COC
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2571
    Method
    		 Mixed effect repeated measures
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.769
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.305
         upper limit
    		 2.766
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.319

    Secondary: Change from Baseline in Patient’s Global Impression of Change (PGIC) at Day 168

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    End point title
    		 Change from Baseline in Patient’s Global Impression of Change (PGIC) at Day 168
    End point description
    The PGIC is a 1-item question that assessed change in a participant’s sexual desire (and feeling bothered about a lack of it) since the start of the current study treatment. Participants rated the change on a 6-point scale. Participants rated this change as very much improved, much improved, moderately improved, minimally improved, no change and worse, where 1= "Very much improved" to 6 = "Worse". FAS: Consisted of all participants who were randomised to one of the blinded treatment arms and took at least 1 dose of blinded study treatment. Participants were analysed according to their randomised treatment, regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 168
    End point values
    		 DHEA 50 mg + COC Placebo + COC
    Number of subjects analysed
    84
    83
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 14 (CYCLE 6 DAY 28/EOT) - Day 168;n=79,n=79
    -2.3 ( 1.62 )
    -2.3 ( 1.69 )
    Statistical analysis title
    		 Change from Baseline in PGIC
    Statistical analysis description
    Analysis of Change from Baseline in Patient’s Global Impression of Change at Day 168 of treatment period 2.
    Comparison groups
    DHEA 50 mg + COC v Placebo + COC
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.935
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.021
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.538
         upper limit
    		 0.495
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.262

    Secondary: Change from Baseline Values of Endocrine Parameters by Visit at Treatment Period 1

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    End point title
    		 Change from Baseline Values of Endocrine Parameters by Visit at Treatment Period 1
    End point description
    All endocrine blood samples were taken between 7 AM and 9 AM. Endocrine measurements included 17-beta-Estradiol (unit: pg/ml), testosterone free serum (unit: pg/ml) , testosterone total serum (unit: µg/l), sex hormone binding globulin (SHBG) (unit: nmol/l), Dehydroepiandrosterone, Prasterone (DHEA) serum (unit: µg/l), Dehydroepiandrosterone sulfate (DHEAS) serum (unit: ng/ml), dihydrotestosterone (unit: ng/l), 3 alpha-androstanediol Glucuronide (3α- ADG) (unit: ng/mL), Androstenedione serum (unit: µg/l), and estrone serum (unit: pg/ml). At the Enrolment visit it was recommended to take endocrine samples after eligibility had been confirmed and participant had been enrolled to the study. FAS: Consisted of all participants who were randomised to one of the blinded treatment arms and took at least 1 dose of blinded study treatment. Participants were analysed according to their randomised treatment, regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline and Visit 4 (Cycle 1 Day 15± 3) to Visit 7 (Cycle 3 Day 15 ± 3)
    End point values
    		 Combined oral contraceptives (COC)
    Number of subjects analysed
    167
    Units: Concentration
    arithmetic mean (standard deviation)
        17-beta-Estradiol Visit 4, n=153
    -114.23 ( 128.730 )
        17-beta-Estradiol Visit 7, n=142
    -106.66 ( 121.292 )
        3α- ADG Visit 4, n=152
    -0.64 ( 5.815 )
        3α- ADG Visit 7, n=141
    -0.23 ( 10.649 )
        Androstenedione serum Visit 4, n=153
    -0.651 ( 0.5441 )
        Androstenedione serum Visit 7, n=141
    -0.572 ( 0.5459 )
        DHEA serum Visit 4, n=153
    -1.48 ( 3.117 )
        DHEA serum Visit 7, n= 141
    -1.42 ( 2.895 )
        DHEAS serum Visit 4, n=153
    -263.1 ( 733.71 )
        DHEAS serum Visit 7, n=142
    -355.5 ( 768.37 )
        Dihydrotestosterone Visit 4, n=155
    -31.1 ( 40.39 )
        Dihydrotestosterone Visit 7, n=144
    -33.2 ( 39.22 )
        Estrone serum Visit 4, n=154
    -60.06 ( 79.029 )
        Estrone serum Visit 7, n=145
    -48.88 ( 55.567 )
        SHBG serum Visit 4, n=154
    26.35 ( 28.050 )
        SHBG serum Visit 7, n=144
    31.68 ( 33.473 )
        Testosterone free serum Visit 4, n=155
    -0.429 ( 0.6104 )
        Testosterone free serum Visit 7, n=145
    -0.370 ( 0.5588 )
        Testosterone total serum Visit 4, n=153
    -0.138 ( 0.1355 )
        Testosterone total serum Visit 7, n=141
    -0.116 ( 0.1349 )
    No statistical analyses for this end point

    Secondary: Change from Baseline Values of Endocrine Parameters by Visit at Treatment Period 2

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    End point title
    		 Change from Baseline Values of Endocrine Parameters by Visit at Treatment Period 2
    End point description
    All endocrine blood samples were taken between 7 AM and 9 AM. Endocrine measurements included 17-beta-Estradiol (unit: pg/ml), testosterone free serum (unit: pg/ml) , testosterone total serum (unit: µg/l), SHBG serum (unit: nmol/l), DHEA serum (unit: µg/l), DHEAS serum (unit: ng/ml), dihydrotestosterone (unit: ng/l), 3α- ADG (unit: ng/mL), Androstenedione serum (unit: µg/l), and estrone serum (unit: pg/ml). At the Enrolment visit it was recommended to take endocrine samples after eligibility had been confirmed and participant had been enrolled to the study. FAS: Consisted of all participants who were randomised to one of the blinded treatment arms and took at least 1 dose of blinded study treatment. Participants were analysed according to their randomised treatment, regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    Baseline and Visit 9 (Cycle 4 Day 15± 3) to Visit 13 (Cycle 6 Day 15± 3)
    End point values
    		 DHEA 50 mg + COC Placebo + COC
    Number of subjects analysed
    84
    83
    Units: Concentration
    arithmetic mean (standard deviation)
        Androstenedione serum Visit 9, (n=55, 50)
    0.379 ( 0.7817 )
    -0.047 ( 0.5679 )
        Androstenedione serum Visit 11, (n=54, 40)
    0.280 ( 0.7869 )
    -0.008 ( 0.5066 )
        Androstenedione serum Visit 13, (n=55, 38)
    0.392 ( 0.6414 )
    -0.033 ( 0.4982 )
        DHEA serum Visit 9, (n=55, 50)
    0.25 ( 4.004 )
    -0.02 ( 2.576 )
        DHEA serum Visit 11, (n=54, 40)
    0.32 ( 3.778 )
    0.25 ( 2.968 )
        DHEA serum Visit 13, (n=55, 38)
    1.46 ( 2.664 )
    -0.12 ( 2.754 )
        Dihydrotestosterone Visit 9, (n=61, 54)
    31.0 ( 56.60 )
    -5.6 ( 30.27 )
        Dihydrotestosterone Visit 11, (n=54, 41)
    31.0 ( 61.94 )
    -2.8 ( 18.32 )
        Dihydrotestosterone Visit 13, (n=55, 40)
    31.7 ( 46.20 )
    -3.1 ( 25.69 )
        Estrone serum Visit 9, (n=61, 55)
    6.23 ( 42.610 )
    -10.04 ( 58.347 )
        Estrone serum Visit 11, (n=54, 43)
    9.78 ( 46.593 )
    3.96 ( 100.192 )
        Estrone serum Visit 13, (n=55, 41)
    6.80 ( 45.147 )
    -2.66 ( 60.739 )
        SHBG serum Visit 9, (n=60, 55)
    7.58 ( 29.650 )
    -0.43 ( 28.099 )
        SHBG serum Visit 11, (n=54, 43)
    -1.18 ( 16.125 )
    -7.09 ( 30.707 )
        SHBG serum Visit 13, (n=54, 41)
    -0.29 ( 31.614 )
    -9.39 ( 20.162 )
        Testosterone free serum Visit 9, (n=61, 55)
    0.160 ( 0.7942 )
    -0.041 ( 0.4559 )
        Testosterone free serum Visit 11, (n=54, 43)
    0.237 ( 0.6697 )
    0.017 ( 0.5846 )
        Testosterone free serum Visit 13, (n=55, 41)
    0.130 ( 0.4919 )
    -0.140 ( 0.5037 )
        Testosterone total serum Visit 9, (n=55, 50)
    0.114 ( 0.1705 )
    -0.030 ( 0.1150 )
        Testosterone total serum Visit 11, (n=54, 40)
    0.110 ( 0.2093 )
    -0.009 ( 0.1080 )
        Testosterone total serum Visit 13, (n=55, 38)
    0.118 ( 0.1610 )
    -0.024 ( 0.1181 )
        DHEAS serum Visit 9, (n=60, 54)
    1661.4 ( 2743.41 )
    5.3 ( 1025.31 )
        DHEAS serum Visit 11, (n=54, 43)
    1720.7 ( 2507.76 )
    24.2 ( 696.23 )
        DHEAS serum Visit 13, (n=54, 40)
    1723.5 ( 2248.14 )
    60.7 ( 719.02 )
        3α- ADG Visit 9, (n=60, 53)
    3.93 ( 5.582 )
    0.38 ( 1.753 )
        3α- ADG Visit 11, (n=53, 42)
    7.39 ( 25.141 )
    -0.57 ( 5.291 )
        3α- ADG Visit 13, (n=53, 39)
    5.30 ( 14.277 )
    -0.87 ( 6.783 )
        17-beta-Estradiol Visit 9, (n=59, 54)
    2.04 ( 61.807 )
    -12.46 ( 73.578 )
        17-beta-Estradiol Visit 11, (n=54, 42)
    2.91 ( 49.687 )
    -5.70 ( 93.648 )
        17-beta-Estradiol Visit 13, (n=55, 39)
    6.12 ( 78.190 )
    -17.68 ( 80.953 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All non-serious adverse events were reported from signing the informed consent (ICF) through 7-day follow-up period. Serious adverse events were collected from signing of ICF until 30 days after last administration of study drug.
    Adverse event reporting additional description
    Safety Set: Safety set consisted of all participants who were administered at least 1 dose of COC or blinded treatment. Participants were analyzed according to the treatment they received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Combined Oral Contraceptive (COC)
    Reporting group description
    		 One COC tablet containing 30 µg ethinylestradiol (EE) and 150 µg levonorgestrel (LNG) was taken orally, once daily, for 21 consecutive days, followed by a 7-day tablet-free interval from Day 22 to Day 28 of each cycle. This 28-day cyclic regimen was taken for 3 cycles in Treatment Period 1.

    Reporting group title
    DHEA 50 mg + COC
    Reporting group description
    		 Eligible participants who completed Treatment Period 1 and qualified at the second baseline (Visit 8) continued to receive COC treatment and were randomized to also receive DHEA during Treatment Period 2. In the second treatment period, one COC tablet containing 30 µg EE and 150 µg LNG was taken on Days 1 to 21 of each cycle and two 25 mg DHEA tablets were taken on Days 1 to 28 of each 28-day cycle. COC + DHEA were taken together, once daily, in the morning, and with a meal. This 28-day cyclic regimen was to be taken for 3 consecutive cycles.

    Reporting group title
    Placebo + COC
    Reporting group description
    		 Eligible participants who completed Treatment Period 1 and qualified at the second baseline (Visit 8) continued to receive COC treatment and were randomized to also receive placebo during Treatment Period 2. In the second treatment period, one COC tablet containing 30 µg EE and 150 µg LNG was taken on Days 1 to 21 of each cycle and two matching placebo (DHEA) tablets were taken on Days 1 to 28 of each 28-day cycle. COC + placebo were taken together, once daily, in the morning, and with a meal. This 28-day cyclic regimen was to be taken for 3 consecutive cycles.

    Serious adverse events
    		 Combined Oral Contraceptive (COC) DHEA 50 mg + COC Placebo + COC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 397 (0.76%)
    0 / 84 (0.00%)
    0 / 84 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Thrombophlebitis
         subjects affected / exposed
    1 / 397 (0.25%)
    0 / 84 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Ureterolithiasis
         subjects affected / exposed
    1 / 397 (0.25%)
    0 / 84 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 397 (0.25%)
    0 / 84 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Combined Oral Contraceptive (COC) DHEA 50 mg + COC Placebo + COC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    87 / 397 (21.91%)
    17 / 84 (20.24%)
    19 / 84 (22.62%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    40 / 397 (10.08%)
    3 / 84 (3.57%)
    8 / 84 (9.52%)
         occurrences all number
    50
    5
    10
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    8 / 397 (2.02%)
    8 / 84 (9.52%)
    6 / 84 (7.14%)
         occurrences all number
    8
    9
    7
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    22 / 397 (5.54%)
    0 / 84 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    31
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    17 / 397 (4.28%)
    6 / 84 (7.14%)
    5 / 84 (5.95%)
         occurrences all number
    18
    6
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Apr 2021
    -It was planned that approximately 55 centres would be initiated for this study in up to 7 countries in geographical Europe. -Planned duration of participant’s participation extended up to approximately 34 weeks (including screening and safety follow-up). -Replaced “Exploratory” with “Additional” to harmonise naming of Objective with Additional endpoint. -Resolved discrepancy in listing of objectives and endpoints -Updated exclusion criteria to include the presence of more than one risk factor (for women ≤ 35 years of age) or one risk factor (for women > 35 years of age) for vascular disease (eg, dyslipoproteinaemia; smoking; venous or arterial thromboembolism in sibling or parent below the age of 50; controlled arterial hypertension; obesity [BMI over 30 kg/m^2]; migraine). -Updated exclusion criteria to include a history during pregnancy or during previous oestrogen use of severe pruritus, herpes gestationis, or deterioration of otosclerosis, chloasma, hereditary or acquired vasomotor oedema. -Updated statistical methods and secondary endpoints from Treatment Period 2 baseline to Day 168 for analysis of the FSDS-R Item 13, using an Analysis of covariance model with Treatment Period 2 baseline values as a covariate and treatment group as factor. -Updated statistical methods and secondary endpoints to the proportion of participants answering the Patient’s Meaningful Benefit Question with “yes” was to be analysed by logistic regression using treatment group as factor.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Jun 2021
    Screening was put on hold globally for the study between 01 June 2021 and re-started on 15 November 2021. Reason: Expiry of old Biosteron (DHEA) and lack of Biosteron availability on the market necessitated putting screening on-hold.
    15 Nov 2021

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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