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MLE4901 vs. Placebo for the Treatment of PCOS

NCT02865915 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2021-02-01

Study results available
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Summary

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

Conditions

  • Polycystic Ovary Syndrome (PCOS)

Interventions

DRUG

MLE4901

For 80% of subjects randomized to MLE4901 (n=24/30), the dose is 40 mg twice daily. Six subjects (20%) randomized to higher MLE4901 dose cohorts that were promptly discontinued.

DRUG

Placebo

Placebo to match active drug

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Covance

    collaborator INDUSTRY

  • Millendo Therapeutics US, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-09-30
Completion
2017-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02865915 on ClinicalTrials.gov