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Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

NCT00683917 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-08-21

Study results available
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Summary

PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Conditions

  • Uterine Fibroids

Interventions

DRUG

Proellex 25 mg

Proellex 25 mg, 1 capsule daily for 4 months

DRUG

Proellex 50 mg

Proellex 50 mg, 2 capsules daily for 4 months

DRUG

Lupron Depot

Lupron 3.75 mg monthly intramuscular injections for 4 months

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Andre vanAs, MD, PhD · Repros Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States
  • Mexico

Study Locations

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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 NCT00683917 on ClinicalTrials.gov