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Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers

Open, Randomized, Parallel Multi-center Comparison of Cycle Control and Safety of the Oral Contraceptive Yasmin 20 in a 24-day Regimen vs. Mercilon for 7 Cycles in 440 Healthy Female Volunteers

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00624130
Enrollment
453
Registered
2008-02-26
Start date
2004-03-31
Completion date
2005-06-30
Last updated
2014-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Contraception,, Cycle control,, Bleeding pattern

Brief summary

The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.

Interventions

DRUGYasmin 20

Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)

DRUGMercilon

Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy female volunteer aged 18-35, * Smokers 18-30

Exclusion criteria

* Contraindications for using hormonal contraceptives

Design outcomes

Primary

MeasureTime frame
Cycle control and bleeding pattern7 cycles

Secondary

MeasureTime frame
Laboratory testsScreening
Adverse Events7 cycles
Pearl index7 cycles
Vital signsScreening, admission
Body weightScreening, admission
General Physical and gynecological examinationsScreening

Countries

Austria, Estonia, Finland, Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026