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Yasmin 20

Phase 3

Contraception | Small molecule | Endocrine |Bayer AG|Last Updated: Dec 31, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment1,295

FDA Designations

No designations recorded

Clinical trial landscape

Yasmin 20 · 2 trials · 1 indication

Phase 3 2
NCT00624130Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female VolunteersContraception
COMPLETED453 Analytics
NCT00185419A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring ContraceptionContraception
COMPLETED842 Analytics
PHASE3COMPLETED
Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers
ContraceptionUnlock trial analytics
PHASE3COMPLETED
A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception
ContraceptionUnlock trial analytics

Study Endpoints

Primary Endpoints

Cycle control and bleeding pattern
7 cycles
The primary efficacy variable is the comparison of cycle control from randomisation to cycle 13. This will be based on the number of subjects reporting at least 1 unexpected intracyclic bleeding episode between cycles 2 to 13.
13 treatment cycles (1 cycle= 28 days)

Secondary Endpoints

Pearl index
7 cycles
Laboratory tests
Screening
Adverse Events
7 cycles
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Yasmin 20DRUGYasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)
MercilonDRUGMercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)
YasminDRUG30 µg ethinylestradiol, 3mg drospirenone
MarvelonDRUG30 µg ethinylestradiol, 150 µg desogestrel
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersYes
Study Sites17

Inclusion Criteria: * Healthy female volunteer aged 18-35, * Smokers 18-30 Exclusion Criteria: * Contraindications for using hormonal contraceptives

Countries:AustriaEstoniaFinlandLithuaniaChina
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Frequently asked questions about Yasmin 20

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.