check_circleStudy Completed

Contraception

US Ovulation Inhibition Study in Obese Women

Trial purpose

Birth Control Patch Study

Key Participants Requirements

Sex

Female

Age

18 - 35 Years

Trial summary

Enrollment Goal
173
Trial Dates
April 2009 - March 2010
Phase
Phase 2
Could I Receive a placebo
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Houston, 77054, United States
Completed
San Diego, 92108, United States
Completed
Seattle, 98105, United States
Completed
Philadelphia, 19114, United States
Completed
Sandy Springs, 30328, United States
Completed
Tucson, 85712, United States

Primary Outcome

  • Determination of Hoogland Scores
    date_rangeTime Frame:
    Treatment Cycles 2 & 3
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Laboratory values for E2, progesterone, FSH and LH
    date_rangeTime Frame:
    Pretreatment & regularly during Treatment Cycles 1, 2, 3
    enhanced_encryption
    Safety Issue:
    no
  • Endometrial thickness
    date_rangeTime Frame:
    Pretreatment & regularly during Treatment Cycles 1, 2, 3
    enhanced_encryption
    Safety Issue:
    no
  • Follicle size
    date_rangeTime Frame:
    Pretreatment & regularly during Treatment Cycles 1, 2, 3
    enhanced_encryption
    Safety Issue:
    no

Trial design

Multicenter, Open-Label, Uncontrolled Study to Investigate the Impact of Weight and BMI on Inhibition of Ovulation of a Transdermal patch Formulation Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene in Young Female Volunteers Stratified by BMI Over a Period of 3 Treatment Cycles
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1