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Efficacy and Safety Oral Contraceptive Study

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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arms and Interventions
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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
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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
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Information from the National Library of Medicine

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185484


Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 of Results:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00185484     History of Changes
Other Study ID Numbers: 91353
308021
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Oral contraception

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Drospirenone
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