Clinical Trial Results:
Double blind crossover randomised controlled trial comparing letrozole versus clomifene citrate for ovulation induction in women with polycystic ovarian syndrome
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Summary
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EudraCT number |
2006-006514-15 |
Trial protocol |
GB |
Global end of trial date |
30 Jun 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Mar 2019
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First version publication date |
16 Mar 2019
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Other versions |
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Summary report(s) |
Double-blind randomized controlled trial of letrozole versus clomiphene citrate in subfertile women with polycystic ovarian syndrome |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
RD-5103-015-06
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00478504 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University of Nottingham
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Sponsor organisation address |
University Park, Nottingham, United Kingdom, NG7 2RD
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Public contact |
Head of Research Governance
Research and Innovation, University of Nottingham
, Professor Saad Amer
School Of Graduate Entry Medicine
University of Nottingham
, +44 1332724612, saad.amer@nottingham.ac.uk
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Scientific contact |
Head of Research Governance
Research and Innovation, University of Nottingham
, Professor Saad Amer
School Of Graduate Entry Medicine
University of Nottingham
, +44 1158467906 , angela.shone@nottingham.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Feb 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Jun 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Jun 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective is to assess the efficacy of letrozole as an ovulation induction agent and to test the hypothesis that letrozole will generate better pregnancy rates than treatment with the current standard agent, clomifene citrate.
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Protection of trial subjects |
This was a low risk trial. All participants were given contact numbers to call any time for any concerns.
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Background therapy |
Nne | ||
Evidence for comparator |
For decades, clomiphene citrate (CC) has been the standard first line ovulation induction (OI) agent in PCOS women with 85% ovulation rates and 40% pregnancy rates. This discrepancy between ovulation and conception rates has been attributed to the peripheral antioestrogenic actions of CC on endometrium and cervix. Letrozole, an aromatase inhibitor that reduces oestrogen synthesis, has recently been considered as a potentially better alternative to CC. In contrast to CC, letrozole is not associated with any anti-oestrogenic effects on endometrium. This is supported by recent studies reporting adequate endometrial thickness during letrozole treatment. Furthermore, unlike CC that accumulates in the body because of its long half-life (two weeks), letrozole is rapidly eliminated due to its short half-life (45 hours), leading to late follicular rise in circulating oestrogen thereby enhancing endometrial development with subsequent increase in the chances of pregnancy. The rising oestrogen levels may also result in a shorter FSH window (mimicking the physiological cycle) with subsequent mono-ovulation and a lower risk of multiple pregnancy. A Cochrane systematic review of clinical trials comparing aromatase inhibitors versus CC concluded that the quality of evidence in the reviewed trials was low due to poor reporting of study methods and possible publication bias. None of the reviewed trials was conducted in Europe. Furthermore, the only robust trial in that review included a high proportion of markedly obese women (Body mass Index (BMI)>40kg/m2), which does not reflect clinical practice in the majority of fertility centres worldwide (Legro et al, 2014). These results are therefore neither conclusive nor generalizable. The review concluded that further research is needed to compare letrozole with CC as a primary ovulation induction (OI) agent in PCOS women. | ||
Actual start date of recruitment |
25 Apr 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 159
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Worldwide total number of subjects |
159
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EEA total number of subjects |
159
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
159
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were recruited at the fertility unit of Royal Derby Hospital between 25 April 2007 and 22 February 2013. | |||||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 202 women with anovulatory infertility due to PCOS were screened for eligibility, of whom 159 were randomized. the remaining 43 women were excluded due to not meeting inclusion criteria (n=25), declining to participate (n=8) or conceiving before recruitment (n=10). | |||||||||||||||||||||
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Period 1
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Period 1 title |
Randomisation
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | |||||||||||||||||||||
Blinding implementation details |
The two medicines investigated in the trial were prepared in identical capsules and provided in identical packages (as explained above). Throughout the study, the patient and the investigator remained blinded to the treatment. Investigators carrying out the monitoring, assessment of response to treatment and data analysis were kept blinded. The dispenser of the medicine kept the identifying tear-off label of each pack to allow unblinking at any time if necessary.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Arm A: Clomifene | |||||||||||||||||||||
Arm description |
79 Participants allocated to clomiphene citrate | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
Investigational medicinal product name |
Clomiphene citrate
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Investigational medicinal product code |
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Other name |
Clomifene citrate
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Clomiphene citrate was given orally daily for five days in the early follicular phase from day 2 to day 6 of a spontaneous menstrual period or a withdrawal bleed induced by progestogen administration. The starting daily dose was one capsule 50 mg. Patients were monitored for ovulation by follicle tracking (using ultrasound) and measurement of serum concentration of progesterone in mid-luteal phase. If the patient did not ovulate on one capsule the dose would be increased in the second cycle to two capsules a day (i.e. 100 mg/day). Once ovulation had been achieved on a certain dose, treatment would be continued until pregnancy is achieved or for up to 6 cycles.
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Arm title
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Arm B: letrozole | |||||||||||||||||||||
Arm description |
80 Participants allocated to letrozole | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Letozole
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Letrozole was given orally daily for five days in the early follicular phase from day 2 to day 6 of a spontaneous menstrual period or a withdrawal bleed induced by progestogen administration. The starting daily dose was one capsule 2.5 mg. Patients were monitored for ovulation by follicle tracking (using ultrasound) and measurement of serum concentration of progesterone in mid-luteal phase. If the patient did not ovulate on one capsule the dose would be increased in the second cycle to two capsules a day (i.e. 5 mg/day). Once ovulation had been achieved on a certain dose, treatment would be continued until pregnancy is achieved or for up to 6 cycles.
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Period 2
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Period 2 title |
Cross-over
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Is this the baseline period? |
No | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | |||||||||||||||||||||
Blinding implementation details |
The two medicines investigated in the trial were prepared in identical capsules and provided in identical packages (as explained above). Throughout the study, the patient and the investigator remained blinded to the treatment. Investigators carrying out the monitoring, assessment of response to treatment and data analysis were kept blinded. The dispenser of the medicine kept the identifying tear-off label of each pack to allow unblinking at any time if necessary.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Arm A: Clomifene | |||||||||||||||||||||
Arm description |
79 Participants allocated to clomiphene citrate | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
Investigational medicinal product name |
Clomiphene citrate
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Investigational medicinal product code |
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Other name |
Clomifene citrate
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Clomiphene citrate was given orally daily for five days in the early follicular phase from day 2 to day 6 of a spontaneous menstrual period or a withdrawal bleed induced by progestogen administration. The starting daily dose was one capsule 50 mg. Patients were monitored for ovulation by follicle tracking (using ultrasound) and measurement of serum concentration of progesterone in mid-luteal phase. If the patient did not ovulate on one capsule the dose would be increased in the second cycle to two capsules a day (i.e. 100 mg/day). Once ovulation had been achieved on a certain dose, treatment would be continued until pregnancy is achieved or for up to 6 cycles.
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Arm title
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Arm B: letrozole | |||||||||||||||||||||
Arm description |
80 Participants allocated to letrozole | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Letozole
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Letrozole was given orally daily for five days in the early follicular phase from day 2 to day 6 of a spontaneous menstrual period or a withdrawal bleed induced by progestogen administration. The starting daily dose was one capsule 2.5 mg. Patients were monitored for ovulation by follicle tracking (using ultrasound) and measurement of serum concentration of progesterone in mid-luteal phase. If the patient did not ovulate on one capsule the dose would be increased in the second cycle to two capsules a day (i.e. 5 mg/day). Once ovulation had been achieved on a certain dose, treatment would be continued until pregnancy is achieved or for up to 6 cycles.
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Baseline characteristics reporting groups
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Reporting group title |
Randomisation
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Arm A: Clomifene
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Patients started on Clomifene then crossed over to Letrozole
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Subject analysis set title |
Arm B: Letrozole
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Patients started on Letrozole then crossed over to Clomifene
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End points reporting groups
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Reporting group title |
Arm A: Clomifene
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Reporting group description |
79 Participants allocated to clomiphene citrate | ||
Reporting group title |
Arm B: letrozole
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Reporting group description |
80 Participants allocated to letrozole | ||
Reporting group title |
Arm A: Clomifene
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Reporting group description |
79 Participants allocated to clomiphene citrate | ||
Reporting group title |
Arm B: letrozole
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Reporting group description |
80 Participants allocated to letrozole | ||
Subject analysis set title |
Arm A: Clomifene
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Patients started on Clomifene then crossed over to Letrozole
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Subject analysis set title |
Arm B: Letrozole
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Patients started on Letrozole then crossed over to Clomifene
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End point title |
Pregnancy rate | |||||||||
End point description |
Pregnancy achieved
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End point type |
Primary
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End point timeframe |
At any time in the trial
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Statistical analysis title |
Difference in pregnancy rate | |||||||||
Statistical analysis description |
Absolute difference in pregnancy rate between arm A and arm B
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Comparison groups |
Arm B: Letrozole v Arm A: Clomifene
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Number of subjects included in analysis |
149
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.018 | |||||||||
Method |
Mixed models analysis | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
0.19
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.03 | |||||||||
upper limit |
0.34 | |||||||||
Variability estimate |
Standard error of the mean
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End point title |
Ovulation rate | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At any time in trial
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Statistical analysis title |
Difference in ovulation rate | |||||||||
Statistical analysis description |
Absolute difference in ovulation rate between the two arms
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Comparison groups |
Arm A: Clomifene v Arm B: Letrozole
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Number of subjects included in analysis |
149
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.173 | |||||||||
Method |
Mixed models analysis | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
0.07
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.05 | |||||||||
upper limit |
0.19 | |||||||||
Variability estimate |
Standard error of the mean
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End point title |
Live birth | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At end of trial treatment
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Statistical analysis title |
Difference in live birth | |||||||||
Statistical analysis description |
Absolute difference in live birth rate between the two arms
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Comparison groups |
Arm A: Clomifene v Arm B: Letrozole
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Number of subjects included in analysis |
149
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.079 | |||||||||
Method |
Mixed models analysis | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
0.14
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
-0.02 | |||||||||
upper limit |
0.29 | |||||||||
Variability estimate |
Standard error of the mean
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End point title |
Pregnancy per ovulating patient | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At end of trial treatment
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Statistical analysis title |
Difference in pregnancy rate per ovulating patien | |||||||||
Statistical analysis description |
Absolute difference in pregnancy rate per patient who achieved ovulation
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Comparison groups |
Arm A: Clomifene v Arm B: Letrozole
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Number of subjects included in analysis |
126
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.038 | |||||||||
Method |
Mixed models analysis | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
0.18
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.01 | |||||||||
upper limit |
0.3 | |||||||||
Variability estimate |
Standard error of the mean
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End point title |
Pregnancy per cycle | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Any time in trial
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Statistical analysis title |
Difference in pregnancy rate per cycle | |||||||||
Comparison groups |
Arm A: Clomifene v Arm B: Letrozole
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Number of subjects included in analysis |
539
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.036 | |||||||||
Method |
Mixed models analysis | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
0.07
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.004 | |||||||||
upper limit |
0.13 | |||||||||
Variability estimate |
Standard error of the mean
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End point title |
Live birth per cycle | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At end of trial
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Statistical analysis title |
Difference in live birth rate per cycle | |||||||||
Statistical analysis description |
Absolute difference in live birth rate per cycle between the two arms
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Comparison groups |
Arm B: Letrozole v Arm A: Clomifene
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Number of subjects included in analysis |
539
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.087 | |||||||||
Method |
Mixed models analysis | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
0.05
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
-0.007 | |||||||||
upper limit |
0.11 | |||||||||
Variability estimate |
Standard error of the mean
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End point title |
Ovulation per cycle | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Any time in trial
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Statistical analysis title |
Difference in ovulation rate per cycle | |||||||||
Comparison groups |
Arm A: Clomifene v Arm B: Letrozole
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Number of subjects included in analysis |
539
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.045 | |||||||||
Method |
Mixed models analysis | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
0.08
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.01 | |||||||||
upper limit |
0.15 | |||||||||
Variability estimate |
Standard error of the mean
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End point title |
Mono-ovulation | |||||||||
End point description |
Ovulation in cycles with only one follicle developed
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End point type |
Secondary
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End point timeframe |
Any time in trial
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Statistical analysis title |
Difference in ovulation from one follicle | |||||||||
Statistical analysis description |
Absolute difference in ovulation where only one follicle present between the two arms
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Comparison groups |
Arm A: Clomifene v Arm B: Letrozole
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Number of subjects included in analysis |
171
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.723 | |||||||||
Method |
Mixed models analysis | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
-0.02
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Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
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lower limit |
-0.13 | |||||||||
upper limit |
0.09 | |||||||||
Variability estimate |
Standard error of the mean
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End point title |
Pregnancy outcome and complications | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At end of pregnancy/trial
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Throughout trial
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
1.0
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Reporting groups
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Reporting group title |
Arm A: Clomifene
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Reporting group description |
79 Participants allocated to clomiphene citrate | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Arm B: letrozole
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Reporting group description |
80 Participants allocated to letrozole | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
