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Extension of Study ZPV-200

NCT01631903 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-04-16

No results posted yet for this study

Summary

The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound.

Conditions

  • Uterine Fibroids

Interventions

DRUG

telepristone acetate 12 mg

12 mg, vaginal capsule, once daily for 4 months

DRUG

telepristone acetate 3 mg

3 mg, vaginal capsule, once daily for 3 months

DRUG

telepristone acetate 6 mg

6 mg, vaginal capsule, once daily for 3 months

DRUG

telepristone acetate 12 mg

12 mg, vaginal capsule, once daily, for 3 months

DRUG

telepristone acetate 24 mg

24 mg, vaginal capsule, once daily for 4 months

Sponsors & Collaborators

  • Repros Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

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 NCT01631903 on ClinicalTrials.gov