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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00910637
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : February 8, 2013
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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

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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

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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 identifier (NCT number): NCT00910637

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Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc. 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
Additional relevant MeSH terms:
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Contraceptive Agents
Ethinyl Estradiol
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female