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Yasmin

Phase 3

Healthy | Small molecule | Other |Bayer AG|Last Updated: Oct 11, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment221

FDA Designations

No designations recorded

Clinical trial landscape

Yasmin · 1 trial · 1 indication

Phase 3 1
NCT00367276Study to Evaluate the Effect of Six Cycles of Treatment With a Combined Oral Contraceptive (EE 0.30 mg/DRSP 3 mg) on Quality of Life.Healthy
COMPLETED221 Analytics
PHASE3COMPLETED
Study to Evaluate the Effect of Six Cycles of Treatment With a Combined Oral Contraceptive (EE 0.30 mg/DRSP 3 mg) on Quality of Life.
Healthy
NCT00367276221
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Study Endpoints

Primary Endpoints

Change of Psychological General Well Being Questionnaire score
pretreatment cycle to cycle 6

Secondary Endpoints

Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)
pretreatment to cycle 6
Subject satisfaction with treatment at final visit
at final visit
Subject evaluation of changes in greasy skin and greasy hair
baseline to cycle 6
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)DRUGYasmin, SH T 470 FA; 30 µg ethinylestradiol and 3 mg drospirenone, oral administration over 6 treatment cycles, one tablet per day for 21 days followed by a 7 day pill-free interval.
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Female requiring contraceptives. * Aged 18 to 35 if a non-smoker, aged 18 to 30 if a smoker. * Regular menstrual cycle (defined as duration of 28 +/- 5 days). Exclusion Criteria: * No Contraindication for OC use

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Frequently asked questions about Yasmin

What is Yasmin used for?

Yasmin is a combined oral contraceptive used for contraception in women. It is being studied in Phase 3 clinical trials for healthy volunteers and for contraception, with trials conducted in China and other countries. The drug is developed by Bayer AG.

Who makes Yasmin?

Yasmin is developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The drug is a small molecule oral contraceptive currently in Phase 3 clinical development.

What phase is Yasmin in?

Yasmin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All three clinical trials for Yasmin are Phase 3 trials, and all have been completed.

What clinical trials is Yasmin in?

Yasmin has been studied in three Phase 3 clinical trials. NCT00185419 compared Yasmin to Marvelon in Chinese women requiring contraception. NCT00367276 evaluated the effect of Yasmin on quality of life. NCT00624130 compared Yasmin 20 to Mercilon in healthy female volunteers.

Is Yasmin the same as Marvelon or Mercilon?

Yasmin is not the same as Marvelon or Mercilon. Clinical trials have compared Yasmin to these other oral contraceptives, but they are distinct products. Yasmin contains drospirenone and ethinyl estradiol, while Marvelon and Mercilon contain different progestins.