Efficacy and Safety Oral Contraceptive Study - Full Text View

Sponsor:	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 (DRSP 3 mg/EE 0.02 mg, BAY86-5300)	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Ethinyl estradiol 1,2-Dihydrospirorenone

U.S. FDA Resources

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 ]

Enrollment:	1129
Study Start Date:	March 2004
Study Completion Date:	January 2006

Arms	Assigned Interventions
Experimental: Arm 1	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

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

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier:	NCT00185484 History of Changes
Other Study ID Numbers:	91353, 308021
Study First Received:	September 13, 2005
Last Updated:	March 19, 2009
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

Keywords provided by Bayer:

Oral contraception

Additional relevant MeSH terms:

Contraceptive Agents
Contraceptives, Oral
Ethinyl Estradiol
Drospirenone
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions

Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Aldosterone Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012