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Study to Evaluate Menses Induction in Women Administered Proellex

NCT00881608 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2014-08-25

Study results available
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Summary

The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.

Conditions

  • Amenorrhea

Interventions

DRUG

Placebo

Placebo, 1 capsule daily for five days

DRUG

Proellex

Proellex, one 3, 6, 12 or 25 mg capsule daily for five days

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Andre van As, M.D., Ph.D · Repros Therapeutics Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-08-31
Completion
2009-08-31

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 NCT00881608 on ClinicalTrials.gov