GA YAZ ACNE in China Phase III

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EE20/Drospirenone (YAZ, BAY86-5300)

In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).

Group Type EXPERIMENTAL

EE20/Drospirenone (YAZ, BAY86-5300)

Intervention Type DRUG

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

Placebo

The participants of the placebo group received inert but identical-appearing, color-matched tablets.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inert tablet

Interventions

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EE20/Drospirenone (YAZ, BAY86-5300)

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

Intervention Type DRUG

Placebo

Inert tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women of age 14-45 years
* \>1 year post-menarche with moderate acne vulgaris who have no known contraindications to combined oral contraceptives
* Otherwise healthy, except for the presence of moderate acne
* Smokers up to a maximum age of 30 (inclusive) at inclusion

Exclusion Criteria

* Pregnancy, lactation (less than three menstrual cycles since delivery, abortion, or lactation before start of treatment)
* Obesity (Body Mass Index \> 30 kg/m2)
* Hypersensitivity to any ingredient of the study drug
* Any disease or condition that may worsen under hormonal treatment

Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No