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Efficacy and Safety Oral Contraceptive Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185484
First received: September 13, 2005
Last updated: March 19, 2009
Last verified: March 2009
History of Changes
  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: 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 May 22, 2013