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Trial record 6 of 25 for:    gestodene

EU/LA Pearl Index Study - Transdermal Contraceptive Patch

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: NCT00914693
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : December 5, 2014
Information provided by (Responsible Party):

Brief Summary:
The aim of the present study is to prove efficacy and safety of a new contraceptive patch.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1694 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 (Material no. 80876395) in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects
Study Start Date : April 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Arm 1 Drug: Ethinylestradiol/Gestodene (BAY86-5016)
7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen

Primary Outcome Measures :
  1. Occurrence of pregnancy [ Time Frame: 13 treatment cycles each consisting of 28 days and follow-up period of 14 days ]

Secondary Outcome Measures :
  1. Cervical smear [ Time Frame: 13 treatment cycles each consisting of 28 days ]
  2. Adverse events [ Time Frame: 13 treatment cycles each consisting of 28 days ]
  3. Bleeding pattern and cycle control [ Time Frame: 13 treatment cycles each consisting of 28 days ]

Other Outcome Measures:
  1. Treatment compliance [ Time Frame: 13 treatment cycles each consisting of 28 days ]
  2. Subjective assessment of satisfaction with the treatment [ 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 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Requiring contraception
  • Normal cervical smear
  • Smokers not older than 30 years
  • History of regular cyclic menstrual periods

Exclusion Criteria:

  • Pregnancy or lactation
  • Obesity (BMI> 30 kg/m2
  • 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): NCT00914693

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Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer Identifier: NCT00914693     History of Changes
Other Study ID Numbers: 91554
2008-004214-27 ( EudraCT Number )
310801 ( Other Identifier: Company internal )
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Fertility control
Additional relevant MeSH terms:
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Contraceptive Agents
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptives, Oral, Combined