Efficacy and Safety Oral Contraceptive Study - Full Text View

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 3


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

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:	1113
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Click here to find results for studies related to Bayer Healthcare products. This link exits the ClinicalTrials.gov site

Publications:

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 Investig. 2011;31(8):519-25. doi: 10.2165/11590260-000000000-00000.

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 Obstet Gynecol Reprod Biol. 2011 Apr;155(2):180-2. doi: 10.1016/j.ejogrb.2010.12.037. Epub 2011 Feb 1.


Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT00185484 History of Changes
Other Study ID Numbers:	91353, 308021
Study First Received:	September 13, 2005
Last Updated:	December 30, 2014
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:


Contraceptives, Oral Contraceptive Agents Contraceptive Agents, Female Pharmacologic Actions	Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015