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NCT00293059 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

A Phase 3 study, sponsored by Bayer.

Completed
Registry status
Phase 3
Development phase
190
Enrollment target

NCT00293059: Completed Phase 3 study, sponsored by Bayer.

NCT00293059 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 190 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00293059, a Phase 3 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 3
Development phase
190 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

Primary Outcome

Up to 8 criteria had to be met for complete response during 90-day period. No bleeding episodes (BE) \>7 days, no \>4 BE, no BE with MBL \>=80 mL, no \>1 BE increase from baseline, no increase from baseline in an individual participant's total number of bleeding days and total number of bleeding days not \>24 days. Additionally, for participants included with prolonged bleeding: decrease between maximum duration during run-in and efficacy \>=2 days excessive bleeding: MBL associated with each ep

Interventions

  • DRUG Placebo
  • DRUG Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)

Trial Details

FieldValue
Enrollment Target 190 participants
Start Date 2005-12
Est. Completion 2008-05
Phase Phase 3
Bayer

591 total trials

What the finished NCT00293059 record still lists

NCT00293059 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).

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

NCT00293059 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00293059 about?

NCT00293059 is a clinical study titled "Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding". The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

What is the current status of trial NCT00293059?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 190 participants. The study started on 2005-12. Estimated completion is 2008-05.

What interventions are being tested in trial NCT00293059?

The interventions under investigation include: Placebo (DRUG), Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) (DRUG).

Who is sponsoring clinical trial NCT00293059?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00293059's enrollment target sits among peer trials

190 1402nd of 2000 higher than 593 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00293059, the US trial registry maintained by the National Library of Medicine. NCT00293059 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.