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Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00910637
First received: May 29, 2009
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

This study is examining a birth control patch for 13 cycles (1 year).


Condition Intervention Phase
Contraception
 Drug: Gestodene/EE Patch (BAY86-5016)
 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: Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects

Resource links provided by NLM:

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

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Occurrence of pregnancy (yes/no) while on treatment [ Time Frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vital signs [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: Yes ]
  • Physical and gynecological examinations [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: Yes ]
  • Laboratory assessments [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: Yes ]
  • Adverse events (AE monitoring) [ Time Frame: 13 treatment cycles each consisting of 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 1502
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Gestodene/EE Patch (BAY86-5016)
55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 13 cycles

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Requiring contraception
  • Normal cervical smear
  • Maximum age for smokers is 35
  • History of regular cyclic menstrual periods

Exclusion Criteria:

  • Pregnancy or lactation
  • Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
  • Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
  • Use of other contraceptive methods than study medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910637

  Show 74 Study Locations
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

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00910637     History of Changes
Other Study ID Numbers: 91555, 310802
Study First Received: May 29, 2009
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Pregnancy prevention
Female contraception
Patch

Additional relevant MeSH terms:
Contraceptive Agents
Gestodene
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
 Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Progestins

ClinicalTrials.gov processed this record on June 17, 2013