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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624130
• Other study ID #: 91352
• Secondary ID: 308020
• Status: Completed
• Phase: Phase 3
• First received: February 18, 2008
• Last updated: December 30, 2014
• Start date: March 2004
• Est. completion date: June 2005

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyEstonia: The State Agency of MedicineLithuania: State Medicine Control Agency - Ministry of HealthAustria: Federal Ministry for Health and WomenUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy female volunteer aged 18-35,

• Smokers 18-30

Exclusion Criteria:

• Contraindications for using hormonal contraceptives

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Estonia,  Finland,  Lithuania, 

References & Publications (2)

Anttila L, Bachmann G, Hernádi L, Kunz M, Marr J, Klipping C. Contraceptive efficacy of a combined oral contraceptive containing ethinyloestradiol 20 µg/drospirenone 3mg administered in a 24/4 regimen: a pooled analysis of four open-label studies. Eur J O — View Citation

Anttila L, Neunteufel W, Petraglia F, Marr J, Kunz M. Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 µg compared with a 21/7 regimen of desogestrel 150 µg/ethinylestradiol 20 µg: a pooled analysis. Clin Drug — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycle control and bleeding pattern		7 cycles	No
Secondary	Pearl index		7 cycles	No
Secondary	Laboratory tests		Screening	Yes
Secondary	Adverse Events		7 cycles	Yes
Secondary	General Physical and gynecological examinations		Screening	Yes
Secondary	Vital signs		Screening, admission	Yes
Secondary	Body weight		Screening, admission	Yes

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