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NCT01631903 · ClinicalTrials.gov registry record · Phase 2

Extension of Study ZPV-200

A Phase 2 study, sponsored by Repros Therapeutics.

Completed
Registry status
Phase 2
Development phase
48
Enrollment target

NCT01631903 is a Phase 2 study that has completed, run by Repros Therapeutics. The registered enrollment target is 48 participants.

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The verdict

NCT01631903, a Phase 2 study, has completed, sponsored by Repros Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
48 participants
Enrollment target

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.

Interventions

  • DRUG telepristone acetate 12 mg
  • DRUG telepristone acetate 3 mg
  • DRUG telepristone acetate 6 mg
  • DRUG telepristone acetate 24 mg

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2012-09
Est. Completion 2014-04
Phase Phase 2

Sponsor

Repros Therapeutics

50 total trials

What the Registry Record Tells You About NCT01631903

The ClinicalTrials.gov registry entry for NCT01631903 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Repros Therapeutics, which has 50 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which telepristone acetate 12 mg is the first listed.

NCT01631903 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01631903 about?

NCT01631903 is a clinical study titled "Extension of Study ZPV-200". 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.

What is the current status of trial NCT01631903?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2012-09. Estimated completion is 2014-04.

What interventions are being tested in trial NCT01631903?

The interventions under investigation include: telepristone acetate 12 mg (DRUG), telepristone acetate 3 mg (DRUG), telepristone acetate 6 mg (DRUG), telepristone acetate 24 mg (DRUG).

Who is sponsoring clinical trial NCT01631903?

This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.