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    Summary
    EudraCT Number:2020-000716-30
    Sponsor's Protocol Code Number:RGL-003-001
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-29
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2020-000716-30
    A.3Full title of the trial
    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.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate a combined oral contraceptive (COC) and dehydroepiandrosterone or placebo to treat decreased sexual desire caused by COC use.
    A.4.1Sponsor's protocol code numberRGL-003-001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGedeon Richter Plc.
    B.1.3.4CountryHungary
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGedeon Richter Plc.
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGedeon Richter Plc.
    B.5.2Functional name of contact pointMedicalInformationScientificService
    B.5.3 Address:
    B.5.3.1Street AddressGyömrői út 19-21.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1103
    B.5.3.4CountryHungary
    B.5.4Telephone number+3615057032
    B.5.5Fax number+361431 5954
    B.5.6E-mailmedinfo@richter.hu
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Microgynon 21, 30 μg + 150 μg, film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETHINYLESTRADIOL
    D.3.9.1CAS number 57-63-6
    D.3.9.4EV Substance CodeSUB07277MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVONORGESTREL
    D.3.9.1CAS number 797-63-7
    D.3.9.4EV Substance CodeSUB08483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Biosteron 25 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPrzedsiebiorstwo Pharmaceutyczne LEK-AM Sp.z.o.o.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrasterone
    D.3.9.1CAS number 53-43-0
    D.3.9.3Other descriptive nameDehydroepiandrosterone
    D.3.9.4EV Substance CodeSUB10002MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypoactive sexual desire disorder (HSDD) secondary to combined oral contraception use.
    E.1.1.1Medical condition in easily understood language
    Decreased sexual desire due to combined oral contraception use
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020933
    E.1.2Term Hypoactive sexual desire disorder
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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 (HSDD secondary to COC use) as measured by Profile of Female Sexual Function (PFSF) Desire Domain.
    E.2.2Secondary objectives of the trial
    • To evaluate self reported perception of low desire (Female Sexual Distress Scale-Revised [FSDS-R] item 13)
    • To evaluate subjects treatment benefit
    • To validate in a nested study PFSF: total scores and single items of PFSF for example:
    - Factor analysis
    - Construct validity (to include convergent validity and known-groups validity)
    - Reliability of the PFSF domains
    - Responsiveness of the PFSF domains
    - Responder definition for the PFSF Desire Domain through an anchor-based approach using Patient Global Impression of Change (PGIC) question and Subject's Meaningful Benefit Question as anchors
    - Verification/test whether previously published threshold of 5 or less indicates low desire on the PFSF Desire Domain by use of receiver operating characteristic (ROC) curve analysis.
    • To evaluate effect of DHEA-S treatment on endocrine parameters as a variable of restored sexual desire
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Treatment Period 1
    1. Women aged 18 to 45 who want to start a COC for contraception and who are willing to use a COC for 6 subsequent cycles.
    2. Women reporting a satisfying sexual life and who are in a monogamous, sexually active relationship for at least 6 months.
    3. Women with normal sexual function at screening and at enrollment visit, defined as
    a. FSFI-6 >19 and
    b. FSFI-6 Desire item ≥ 3 [i.e., score on 6-item Female Sexual Function Index (FSFI-6) >19 with Desire (1st Item, level of sexual interest) = 3 or higher (1 or 2 = very low or none at all, or low; maximum score = 5)]
    4. Good physical and mental health as judged by the investigator through prospective evaluation at screening (medical history, physical and gynecological (including breast) examination, clinical laboratory and vital signs).
    5. Premenopausal women having regular menstrual cycles (21 to 35 days)
    6. Monogamous partner who is without sexual dysfunction (per female subject's report) and who is available to the subject at least half the time every month.
    7. Willing to give written informed consent
    8. Women having a functional relationship as per investigator judgement (considering all information, e.g. interview with the clinician, Locke-Wallace Marital Adjustment Test [MAT]) and Decreased Sexual Desire Screener (DSDS).
    9. Negative serum pregnancy test at screening and negative urine pregnancy test at enrollment visit.
    10. Agree to not donate any blood or blood products during the study and in the 3 months after this study.

    Treatment Period 2
    1. Decreased sexual function (desire) due to COC use defined as:
    a) Merits diagnosis of COC-associated HSDD on Decreased Sexual Desire Screener (DSDS-OC) and
    b) FSFI-6 Desire item < 3
    2. Good physical and mental health as judged by the investigator through prospective evaluation (physical and gynecological (including breast) examination, clinical laboratory and vital signs)
    3. Same monogamous partner as during treatment period 1 who is without sexual dysfunction (per female subject's report) and who is available to the subject at least half the time every month
    4. Women continue to have a functional relationship as per subject report
    5. Negative urine pregnancy test at 2nd baseline (Visit 8).
    E.4Principal exclusion criteria
    Treatment Period 1
    1. Use of any hormonal contraceptive method in the prior 3 months
    2. Use of depot or injectable hormonal contraception in the prior 6 months
    3. History of or diagnosed with psychosis, depression or anxiety as per medical history and interview with the clinician
    4. Regular use within 6 months before screening, or current use, of any medication regularly associated with sexual dysfunction or known to affect sexual arousal or desire (as per protocol)
    5. Chronic or acute life stress that interferes with sexual function or sexual activity
    6. Androgen therapy, using OTC anabolic steroids within 3 months prior to screening, topical testosterone within 7 days before screening
    7. Moderate, severe or cystic acne; clinically significant hirsutism; male pattern hair loss
    8. Hyperandrogenic conditions (examples per protocol)
    9. Lactation, pregnancy; or status post-partum or post-abortion within 6 months before screening; intention to become pregnant during the study
    10. Abnormal cervical smear (except: ASCUS with negative reflex HPV test)
    11. Clinically significant abnormal laboratory results at screening in the opinion of the investigator, including fasting serum glucose
    12. History of, or diagnosed with alcohol or drug abuse within 12 months before screening
    13. Any arterial hypertension defined by blood pressure values of a) systolic blood pressure ≥ 140 mmHg and /or b) diastolic blood pressure ≥ 90 mmHg
    14. Diabetes mellitus, systemic lupus erythematosus; chronic inflammatory bowel disease, dyslipoproteinemia requiring active treatment with antilipidemic agent, hemolytic uremic syndrome, sickle cell disease, Sydenham’s chorea
    15. Contraindication and risks for contraceptive steroids (as per protocol)
    16. Treatment with anticoagulants during the study and within 2 weeks before screening
    17. Use of any drug within 2 weeks before screening potentially triggering interactions with COC
    18. Any disease or condition that could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the investigational products
    19. Has any urologic or gynecologic condition that may, in the investigator’s opinion, affect sexual activity and/or function
    20. Uncontrolled thyroid disorders or abnormal clinically significant TSH at screening
    21. AST and/or ALT results ≥ 1.5 x ULN or total serum bilirubin > 1.5 x ULN at screening
    22. ≥ 3 recurrent vaginal and urinary infection within 1 year prior to screening
    23. Malignant disease except well treated squamous or basal cell cancer of the skin
    24. Severe renal condition or eGFR <60 mL/min at screening
    25. Galactose, fructose, lactose intolerance
    26. Subjects who have used any investigational drug in any clinical trial within 3 months prior to the first dose of COC or within five-times the half-life period of the drug used in previous study, whichever is longer
    27. Positive UDS at screening

    Treatment Period 2
    1. Development of another female sexual dysfunction that predominates clinically over HSDD secondary to hormonal contraceptive use
    2. Use of any other hormonal contraceptive method or hormonal medications other than the dispensed LNG/EE study drug in the treatment period 1
    3. Development of psychosis, depression or anxiety; or another psychiatric disorder or new life stress that interferes with sexual function/ activity during treatment period 1
    4. Initiation of any medication during treatment period 1 that interferes with sexual function
    5. Moderate, severe or cystic acne; clinically significant hirsutism; male pattern hair loss
    6. Hyperandrogenic conditions ( per protocol)
    7. Pregnancy
    8. Clinically significant abnormal laboratory results prior to 2nd baseline (at Visit 7) in the opinion of the investigator
    9. Arterial hypertension (as per protocol)
    10. Development of diabetes mellitus, systemic lupus erythematosus; chronic inflammatory bowel disease, dyslipoproteinemia requiring active treatment with antilipidemic agent, hemolytic uremic syndrome, sickle cell disease, Sydenham’s chorea
    11. Development of medical condition that may contribute to impaired sexual activity and function and, in the investigator’s opinion, be the primary cause of sexual dysfunction
    12. Development of medical condition that would cause risk or contraindication to COC (as per protocol)
    13. Development of any disease or condition that could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the investigational products
    14. Use of any prohibited medication during treatment period 1
    15. AST and/or ALT results ≥1.5 x the ULN or total serum bilirubin >1.5 x ULN prior to 2nd baseline at Visit 7
    16. Development of malignant disease except well treated squamous or basal cell cancer of the skin
    17. Development of severe renal condition or eGFR<60 mL/min prior to 2nd baseline (Visit 7)
    18. Development of galactose, fructose, lactose intolerance
    E.5 End points
    E.5.1Primary end point(s)
    PFSF Desire Domain, change from baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from treatment period 2 baseline to Day 168
    E.5.2Secondary end point(s)
    • FSDS-R item 13, change from baseline
    • Proportion of subjects answering the Patient’s Meaningful Benefit Question as “yes”
    • PFSF Responsiveness domain, change from baseline
    • PFSF Arousal domain, change from baseline
    • PFSF Orgasm domain, change from baseline
    • PFSF Pleasure domain, change from baseline
    • PFSF Concerns domain, change from baseline
    • PFSF Self-image domain, change from baseline
    • PFSF total score, change from baseline
    • Endocrine parameters: absolute levels and change from screening to final cycle in treatment period 1 and change from final cycle in treatment period 1 to final cycle in treatment period 2, correlation with efficacy parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from treatment period 2 baseline to Day 168

    Endocrine timepoints: Change from screening to final cycle in treatment period 1 and change from final cycle in treatment period 1 to final cycle in treatment period 2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    Hungary
    Poland
    Bulgaria
    Romania
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 512
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 375
    F.4.2.2In the whole clinical trial 512
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-05
    P. End of Trial
    P.End of Trial StatusOngoing
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