check_circleStudy Completed

Contraception

Bayer Identifier:

14287

ClinicalTrials.gov Identifier:

NCT00896571

EudraCT Number:

2009-010599-45

EU CT Number:

Not Available
Transdermal contraceptive patch - endometrial effects study

Trial purpose

The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Requiring contraception
    - Normal cervical smear
    - Smokers not older than 30 years
    - History of regular cyclic menstrual periods
  • - 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

Trial summary

Enrollment Goal
92
Trial Dates
July 2009 - August 2011
Phase
Phase 2
Could I Receive a placebo
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
emovis GmbHBerlin, 10629, Germany

Primary Outcome

  • Effect on the endometrium at cycle 13
    date_rangeTime Frame:
    13 treatment cycles (each consisting of 28 days)
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Cervical smear
    date_rangeTime Frame:
    13 treatment cycles (each consisting of 28 days)
    enhanced_encryption
    Safety Issue:
    yes
  • Adverse events
    date_rangeTime Frame:
    13 treatment cycles (each consisting of 28 days)
    enhanced_encryption
    Safety Issue:
    yes
  • Cycle control
    date_rangeTime Frame:
    13 treatment cycles (each consisting of 28 days)
    enhanced_encryption
    Safety Issue:
    no
  • Safety laboratory
    date_rangeTime Frame:
    13 treatment cycles (each consisting of 28 days)
    enhanced_encryption
    Safety Issue:
    yes
  • Occurence of pregnancy
    date_rangeTime Frame:
    13 treatment cycles (each consisting of 28 days)
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Single-center,open-label, uncontrolled study to investigate the effects of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene on the endometrium in a 21-day regimen for 13 cycles in 80 healthy women
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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