Efficacy and Safety Oral Contraceptive Study - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185484

Purpose

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

Condition	Intervention	Phase
Contraception	Drug: YAZ (ethinyl estradiol drospirenone, SH T 186 D)	Phase III

MedlinePlus related topics: Birth Control

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Bayer:

Primary Outcome Measures:

Rate of unintended pregnancies (Pearl index) [ Time Frame: 13 cycles of 28 days ]

Secondary Outcome Measures:

Physical and gynecological examination [ Time Frame: screening, cycle 6 and final examination ]
Vital signs [ Time Frame: each visit ]
Body weight [ Time Frame: each visit ]
Cervical smear [ Time Frame: each visit ]

Arms	Assigned Interventions
Arm 1: Experimental N/A	Drug: YAZ (ethinyl estradiol drospirenone, SH T 186 D) Oral administration of YAZ (0.02 mg ethinyl estradiol-ß-cyclodextrin clathrate and 3 mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles

Detailed 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.

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185484

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Responsible Party:	( Bayer Schering Pharma AG, Therapeutic Area Head )
Study ID Numbers:	91353, 308021
Study First Received:	September 13, 2005
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00185484
Health Authority:	Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Slovakia: State Institute for Drug Control; Czech Republic: State Institute for Drug Control; Italy: Competent Authority of Cagliari; United States: Food and Drug Administration

Keywords provided by Bayer:

Oral contraception

Study placed in the following topic categories:

Estradiol 3-benzoate
Estradiol valerate
Drospirenone
Ethinyl Estradiol

Estradiol 17 beta-cypionate
Healthy
Polyestradiol phosphate
Estradiol

Additional relevant MeSH terms:

Estrogens
Aldosterone Antagonists
Hormone Antagonists
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009