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NCT00196378 · ClinicalTrials.gov registry record · Phase 3

A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy

A Phase 3 study, sponsored by Duramed Research.

Completed
Registry status
Phase 3
Development phase
300
Enrollment target

NCT00196378 is a Phase 3 study that has completed, run by Duramed Research. The registered enrollment target is 300 participants.

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The verdict

NCT00196378, a Phase 3 study, has completed, sponsored by Duramed Research.

COMPLETED
Registry status
Phase 3
Development phase
300 participants
Enrollment target

Study Summary

This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

Interventions

  • OTHER Placebo
  • DRUG Synthetic Conjugated estrogens, B

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2004-11
Est. Completion 2006-02
Phase Phase 3

Sponsor

Duramed Research

23 total trials

What the Registry Record Tells You About NCT00196378

The ClinicalTrials.gov registry entry for NCT00196378 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duramed Research, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00196378 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00196378 about?

NCT00196378 is a clinical study titled "A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy". This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

What is the current status of trial NCT00196378?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2004-11. Estimated completion is 2006-02.

What interventions are being tested in trial NCT00196378?

The interventions under investigation include: Placebo (OTHER), Synthetic Conjugated estrogens, B (DRUG).

Who is sponsoring clinical trial NCT00196378?

This trial is sponsored by Duramed Research, which has 23 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.