Millendo - MLE4901-101 - Polycystic Ovary Syndrome - Phase 2b
Research type
Research Study
Full title
A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)
IRAS ID
208640
Contact name
Margaret Ijzerman
Contact email
Sponsor organisation
Millendo Therapeutics, Inc.
Eudract number
2016-002179-91
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 19 days
Research summary
The purpose of this study is to measure the effectiveness of the experimental study drug MLE4901 compared to placebo in women with polycystic ovary syndrome (PCOS) who have infrequent menstrual periods.
PCOS is one of the most common endocrine system disorders (approximately 5-10% of women overall), and the exact cause of PCOS is not yet known. Women with PCOS have irregular hormone levels that cause enlarged ovaries due to multiple small collections of fluid within the ovary.
Common symptoms of PCOS include infrequent menstrual periods, acne and increased hair growth. Women with PCOS may also have an increased risk of having weight gain and diabetes.
Current research suggests PCOS may be linked to how often the hormone "gonadotropin-releasing hormone" (GnRH) is produced/released, these releases are known as pulses. Women with PCOS have more frequent pulses than women without PCOS, resulting in the irregular hormone levels that cause enlarged ovaries and higher than normal levels of male hormones like testosterone.
Previous studies involving the study drug indicate that it may decrease the frequency of GnRH pulses. This could potentially control the symptoms of PCOS, including potentially restoring regularity of menstruation and ovulation.
The primary measure for the effectiveness of the study drug will be how much the regularity of menstruation is affected in those taking the study drug compared to those taking placebo.
Approximately 220 participants will be recruited for this study. All participants will follow the study scheme:
• screening period of up to 12 weeks prior to lead-in
• 8-week lead-in period (with progestin challenge (5 days of medroxyprogesterone 10 mg self-dosed once a day)
• 28-week treatment period
• 8-week follow-up periodParticipants will be randomised into 4 different treatment groups with a 75% chance of being on study drug and a 25% chance of being in the placebo group:
• MLE4901 one 40 mg tablet twice a day
• MLE4901 one 60 mg tablet twice a day
• MLE4901 one 80 mg tablet twice a day
• Placebo tablets twice a dayREC name
London - Riverside Research Ethics Committee
REC reference
16/LO/2038
Date of REC Opinion
17 Jan 2017
REC opinion
Further Information Favourable Opinion