CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 179 enrolled
Drug / intervention
EE20/Drospirenone (YAZ, BAY86-5300) +1 moredrug
Likely dose
EE20/Drospirenone (YAZ, BAY86-5300) 20µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00818519
NCT00818519Phase 3Completed
CompareCT.gov

A Multicenter, Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of an Oral Contraceptive Preparation YAZ (Drospirenone 3 mg / Ethinylestradiol 20 µg) for 6 Treatment Cycles in Women With Moderate Acne

Bayer·interventional·Posted Jan 7, 2009·Updated Aug 25, 2015

In Brief

A Phase 3 clinical trial evaluating EE20/Drospirenone (YAZ, BAY86-5300) and Placebo for Acne Vulgaris. Completed, enrolled 179 participants across 7 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of YAZ (drospirenone 3 mg / ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne vulgaris over 6 treatment cycles.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2009
Enrollment StartDec 1, 2008
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.5 years ago

Interventions

EE20/Drospirenone (YAZ, BAY86-5300)drug

20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd

Placebodrug

Inert tablet