Efficacy and Safety Oral Contraceptive Study

Contraception Clinical Trial

Official title:

Multi-center, Open, Uncontrolled Study to Investigate the Efficacy and Safety of the Oral Contraceptive SH T 186 D Containing 0.02 mg Ethinylestradiol-b-cyclodextrin Clathrate and 3 mg Drospirenone in a 24-day Regimen for 13 Cycles in 1010 Healthy Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185484
• Other study ID #: 91353
• Secondary ID: 308021
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: December 30, 2014
• Start date: March 2004
• Est. completion date: January 2006

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of PharmacyLatvia: State Agency of MedicinesSlovakia: State Institute for Drug ControlCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age

Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1113
• Est. completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy woman requesting contraception

• Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive)

Exclusion Criteria:

• Any conditions might interfere study outcome

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
Oral 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

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	Rate of unintended pregnancies (Pearl index)		13 cycles of 28 days
Secondary	Physical and gynecological examination		screening, cycle 6 and final examination
Secondary	Vital signs		each visit
Secondary	Body weight		each visit
Secondary	Cervical smear		each visit

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer Healthcare products.