TerminatedPhase 2

MLE4901 vs. Placebo for the Treatment of PCOS

Stopped: The risk/benefit profile no longer indicated continued development.

United States55 participantsStarted 2016-07

Plain-language summary

This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of MLE4901 versus placebo in women with PCOS.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Oligo-/amenorrhea
. At least one of the following during Screening:
. Body mass index (BMI) 22 to 45 kg/m2, inclusive
. Must be willing to avoid use of all hair removal procedures and products during study participation
. Must be willing to avoid all prescription treatments for acne and not increase the dose or frequency of their current non-prescription acne treatment regimen during study participation
. Must be willing to avoid the use of all hair growth procedures and products during study participation
. Permanently surgically sterilized (bilateral salpingectomy or tubal occlusion) \>2 years or male partner(s) has had a vasectomy \>2 years or must consent to use two permitted medically-acceptable methods of contraception throughout the study during any sexual intercourse with a male partner. Permitted medically-acceptable methods of birth control for this study are defined as use of a male condom plus one of the following: spermicide, diaphragm with spermicide, or an intrauterine device that does not contain steroid hormones.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Menstrual Cycle Duration

Timeframe: 28 Week double blind treatment period

Trial details

NCT IDNCT02865915

SponsorMillendo Therapeutics US, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09

Results submitted2020-06-01

View on ClinicalTrials.gov More Polycystic Ovary Syndrome (PCOS) trials

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Oligo-/amenorrhea
. At least one of the following during Screening:
. Body mass index (BMI) 22 to 45 kg/m2, inclusive
. Must be willing to avoid use of all hair removal procedures and products during study participation
. Must be willing to avoid all prescription treatments for acne and not increase the dose or frequency of their current non-prescription acne treatment regimen during study participation
. Must be willing to avoid the use of all hair growth procedures and products during study participation
. Permanently surgically sterilized (bilateral salpingectomy or tubal occlusion) \>2 years or male partner(s) has had a vasectomy \>2 years or must consent to use two permitted medically-acceptable methods of contraception throughout the study during any sexual intercourse with a male partner. Permitted medically-acceptable methods of birth control for this study are defined as use of a male condom plus one of the following: spermicide, diaphragm with spermicide, or an intrauterine device that does not contain steroid hormones.

MLE4901 vs. Placebo for the Treatment of PCOS

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

MLE4901 vs. Placebo for the Treatment of PCOS

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria