Trial · NCT02865915

MLE4901 vs. Placebo for the Treatment of PCOS

NCT02865915, Phase 2, Terminated, Millendo Therapeutics US, Inc.; results first posted 2020-06-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. MLE4901 vs. Placebo for the Treatment of PCOS. Trials, record NCT02865915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02865915

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: MLE4901 vs. Placebo for the Treatment of PCOS
NCT number: NCT02865915
Status: Terminated
Phases: Phase 2
Enrollment: 55 participants, actual
Lead sponsor: Millendo Therapeutics US, Inc.
Conditions: Polycystic Ovary Syndrome (PCOS)
Interventions: MLE4901, Placebo
First posted: 2016-08-15
Last updated: 2021-02-01
Other registries' IDs: eudract:2016-002179-91
Results first posted: 2020-06-16
Limitations and caveats: Due to termination of the study by the Sponsor, no patients completed the study. No efficacy data are available because study termination occurred prior to scheduled assessments.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Menstrual Cycle Duration	28 Week double blind treatment period	Assessment of the number of days between menstrual cycles (i.e., days between the start of a menstrual period and the start of the next consecutive menstrual period) from baseline to end of 28 week double blind treatment period
Secondary	Number of Menstrual Periods	28 Week double blind treatment period	Number of menstrual periods from baseline to the end of the 28 week double blind treatment period

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Menstrual Cycle Duration	28 Week double blind treatment period	The trial was terminated prior to collection of any efficacy data.
SECONDARY	Number of Menstrual Periods	28 Week double blind treatment period	Study terminated prior to collection of efficacy data.

Source ClinicalTrials.gov

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Treatment Arm	25
Overall Study	STARTED	MLE4901 Treatment Arm	30
Overall Study	COMPLETED	Placebo Treatment Arm	0
Overall Study	COMPLETED	MLE4901 Treatment Arm	0
Overall Study	NOT COMPLETED	Placebo Treatment Arm	25
Overall Study	NOT COMPLETED	MLE4901 Treatment Arm	30

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Placebo Treatment Arm	5	25	6
other	Nausea	Gastrointestinal disorders	MLE4901 Treatment Arm	3	30	4
other	Diarrhea	Gastrointestinal disorders	Placebo Treatment Arm	4	25	4
other	Diarrhea	Gastrointestinal disorders	MLE4901 Treatment Arm	1	30	1
other	Alanine aminotransferase increased	Investigations	Placebo Treatment Arm	2	25	2
other	Alanine aminotransferase increased	Investigations	MLE4901 Treatment Arm	5	30	5
other	Aspartate aminotransferase increased	Investigations	Placebo Treatment Arm	2	25	2
other	Aspartate aminotransferase increased	Investigations	MLE4901 Treatment Arm	4	30	4
other	Headache	Nervous system disorders	Placebo Treatment Arm	2	25	2
other	Headache	Nervous system disorders	MLE4901 Treatment Arm	2	30	2

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Treatment Arm	0	25
Total, all-cause mortality	MLE4901 Treatment Arm	0	30
Total, other adverse events	Placebo Treatment Arm	15	25
Total, other adverse events	MLE4901 Treatment Arm	18	30
Total, serious adverse events	Placebo Treatment Arm	0	25
Total, serious adverse events	MLE4901 Treatment Arm	1	30

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
MLE4901 Treatment Arm vs Placebo Treatment Arm: deaths from any cause	Trial comparisons
MLE4901 Treatment Arm vs Placebo Treatment Arm: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02865915

GET https://conductscience.org/api/trials/v1/NCT02865915/registered

API reference For AI assistants