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YAZ

Phase 3

Acne Vulgaris | Small molecule | Dermatology |Bayer AG|Last Updated: Dec 31, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment1,075

FDA Designations

No designations recorded

Clinical trial landscape

YAZ · 5 trials · 3 indications

Phase 3 4Phase 2 1
NCT00819312YAZ, Oral Contraceptive Registration in ChinaContraception
COMPLETED675 Analytics
NCT00185484Efficacy and Safety Oral Contraceptive StudyContraception
COMPLETED1,113 Analytics
NCT00651469Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne.Acne Vulgaris
COMPLETED534 Analytics
NCT00656981Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate AcneAcne Vulgaris
COMPLETED541 Analytics
PHASE3COMPLETED
YAZ, Oral Contraceptive Registration in China
ContraceptionUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety Oral Contraceptive Study
ContraceptionUnlock trial analytics
PHASE3COMPLETED
Evaluate Safety and Efficacy of an OC Preparation vs Placebo for 6 Treatment Cycles in Women With Moderate Acne.
Acne VulgarisUnlock trial analytics
PHASE3COMPLETED
Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne
Acne VulgarisUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment.
13 cycles (1 cycle= 28 days)
Rate of unintended pregnancies (Pearl index)
13 cycles of 28 days
Percent change in inflammatory lesion counts (including papules, pustules, and nodules), non-inflammatory lesion counts (including open and closed comedones), total lesion count, and the ISGA.
From baseline to Cycle 6
Hoogland scores in cycles 2 and 3
Treatment cycles 2 and 3 (treatment weeks 5-12)

Secondary Endpoints

Bleeding pattern indices
13 cycles
Cycle control parameters
13 cycles
Adverse events
Whole study period
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR -
Arm 2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
YAZ (SH T00186, BAY86-5300)DRUG20ug ethinylestradiol, 3mg drospirenone, tablet, orally, opd
YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)DRUGOral administration of YAZ (0.02mg ethinyl estradiol-ß-cyclodextrin clathrate and 3mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles
PlaceboDRUGThe subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)
Yasminelle (SH T 00186 D)DRUGSH T 00186 D in a 21-day regimen, i.e., 21 verum tablets, 7 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each
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Eligibility Criteria

Age Range18 Years to 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites17

Inclusion Criteria: * Healthy women between 18 and 45 requesting oral contraception. * Smokers may not exceed 30 years of age. Exclusion Criteria: * The use of steroidal oral contraceptives , or any drug that could alter oral contraception metabolism will be prohibited during the study. * Pregnan...

Countries:ChinaHong KongUnited StatesNetherlands
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Frequently asked questions about YAZ

What is YAZ used for?

YAZ is an oral contraceptive used for contraception and for the treatment of acne vulgaris. It is a small molecule developed by Bayer AG. Clinical trials have evaluated YAZ in women for contraception and in women with moderate acne, with completed Phase 3 studies in both indications.

Who makes YAZ?

YAZ is developed by Bayer AG, a company traded under the ticker BAYRY. Bayer has conducted clinical trials for YAZ in contraception and acne vulgaris, including studies in the United States, China, Hong Kong, and the Netherlands.

What phase is YAZ in?

YAZ is in Phase 3 clinical development. It has completed Phase 3 trials for contraception and acne vulgaris. YAZ is investigational and still in clinical development, with no indication that it is FDA approved based on the available data.

What clinical trials is YAZ in?

YAZ has completed several clinical trials, including NCT00185484 for contraception with 1113 participants, NCT00651469 for moderate acne with 534 participants, and NCT00819312 for contraception in China with 675 participants. A Phase 2 trial, NCT00673686, studied missed pills and follicular development.

Is YAZ the same as SH T 00186 D?

YAZ is associated with the study drug SH T 00186 D, which was evaluated in a clinical trial for oral contraceptives. The trial NCT00673686 investigated the effect of missed pills on follicular development in two application regimens of SH T 00186 D.