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

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ClinicalTrials.gov Identifier: NCT00910637
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : February 8, 2013
Sponsor:
Information provided by:
Bayer

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

Condition or disease Intervention/treatment Phase
Contraception Drug: Gestodene/EE Patch (BAY86-5016) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1502 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Arm 1 Drug: Gestodene/EE Patch (BAY86-5016)
55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 13 cycles



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Vital signs [ Time Frame: 13 treatment cycles each consisting of 28 days ]
  2. Physical and gynecological examinations [ Time Frame: 13 treatment cycles each consisting of 28 days ]
  3. Laboratory assessments [ Time Frame: 13 treatment cycles each consisting of 28 days ]
  4. Adverse events (AE monitoring) [ Time Frame: 13 treatment cycles each consisting of 28 days ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

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): NCT00910637


  Show 74 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00910637     History of Changes
Other Study ID Numbers: 91555
310802 ( Other Identifier: Company internal )
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013

Keywords provided by Bayer:
Pregnancy prevention
Female contraception
Patch

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