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NCT00651469 · ClinicalTrials.gov registry record · Phase 3

Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne.

A Phase 3 study of Acne Vulgaris, sponsored by Bayer.

Completed
Registry status
Phase 3
Development phase
534
Enrollment target
20
Study locations

NCT00651469 is a Phase 3 study of Acne Vulgaris that has completed, run by Bayer. The registered enrollment target is 534 participants, above the 267-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (100% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT00651469, a Phase 3 study of Acne Vulgaris, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 3
Development phase
534 participants
Enrollment target
20
Study locations

Study Summary

The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles.

Conditions Studied

Acne Vulgaris

Interventions

  • DRUG Placebo
  • DRUG YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)

Study Locations (20)

Florida

  • - Miami
  • - St. Petersburg
  • - Tampa

Alabama

  • - Birmingham
  • - Huntsville

California

  • - Los Angeles
  • - San Diego

North Carolina

  • - Winston-Salem
  • - Winston-Salem

Arizona

  • - Mesa

District of Columbia

  • - Washington D.C.

Idaho

  • - Boise

Illinois

  • - Chicago

Trial Details

FieldValue
Enrollment Target 534 participants
Start Date 2003-01
Est. Completion 2004-07
Phase Phase 3

Sponsor

Bayer

591 total trials

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What the Registry Record Tells You About NCT00651469

The ClinicalTrials.gov registry entry for NCT00651469 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 534 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 267-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (100% higher). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00651469 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT00651469 about?

NCT00651469 is a clinical study titled "Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne.". The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles.

What is the current status of trial NCT00651469?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 534 participants. The study started on 2003-01. Estimated completion is 2004-07.

What conditions does trial NCT00651469 study?

This clinical trial studies the following conditions: Acne Vulgaris.

What interventions are being tested in trial NCT00651469?

The interventions under investigation include: Placebo (DRUG), YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) (DRUG).

Who is sponsoring clinical trial NCT00651469?

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

Where is trial NCT00651469 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.