Efficacy and Safety Oral Contraceptive Study

• ClinicalTrials.gov Identifier: NCT00185484
• Recruitment Status: Completed
• First Posted: September 16, 2005
• Last Update Posted: December 31, 2014
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Contraception	Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1113 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: March 2004
• Actual Study Completion Date: January 2006

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes 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

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Additional Information:

Click here to find results for studies related to Bayer Healthcare products. 

Publications of Results:

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):519-525. 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
• First Posted: September 16, 2005
• Last Update Posted: December 31, 2014
• Last Verified: December 2014

Keywords provided by Bayer:

Oral contraception

Additional relevant MeSH terms:

Drospirenone; Contraceptive Agents; Contraceptives, Oral; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Female; Mineralocorticoid Receptor Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents