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.

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

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

✓. 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.

✕. Menopausal or peri-menopausal, defined for this study as FSH (follicle stimulating hormone ) \>10 IU/L
✕. Irregular vaginal/menstrual bleeding caused by conditions other than PCOS (e.g., uterine polyps or submucosal uterine fibroids)
✕. Abnormal Papanicolaou (Pap) test during Screening requiring follow-up sooner than 1 year after the test

Menstrual Cycle Duration

Timeframe: 28 Week double blind treatment period

NCT IDNCT02865915

SponsorMillendo Therapeutics US, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09

Results submitted2020-06-01

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

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

✓. 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.

✕. Menopausal or peri-menopausal, defined for this study as FSH (follicle stimulating hormone ) \>10 IU/L
✕. Irregular vaginal/menstrual bleeding caused by conditions other than PCOS (e.g., uterine polyps or submucosal uterine fibroids)
✕. Abnormal Papanicolaou (Pap) test during Screening requiring follow-up sooner than 1 year after the test