GA YAZ ACNE in China Phase III

Bayer

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Placebo; Drug: EE20/Drospirenone (YAZ, BAY86-5300)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00818519

91772

311963 (Other Identifier)

2014-004612-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: Female

Ages: 14 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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179 participants in 2 patient groups, including a placebo group

EE20/Drospirenone (YAZ, BAY86-5300)

Experimental group

Description:

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).

Treatment:

Drug: EE20/Drospirenone (YAZ, BAY86-5300)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo