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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: Completed Phase 3 study of Acne Vulgaris, sponsored by Bayer.

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Bayer

591 total trials

What the finished NCT00651469 record still lists

NCT00651469 is an interventional study that assigns participants to a tested intervention. The registered 534 participants enrollment target is mid-sized for trials with a published cap, above the 267-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (100% higher).

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 names 20 study sites across 15 states, led by 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.

Learn More About Clinical Trials

Similar trials for Acne Vulgaris

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00651469's enrollment target sits among peer trials

534 15th of 67 higher than 53 of 67 other Acne Vulgaris trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acne Vulgaris 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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Related registry views

Source: ClinicalTrials.gov NCT00651469, the US trial registry maintained by the National Library of Medicine. NCT00651469 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.