check_circleStudy Completed

Contraception

Bayer Identifier:

13871

ClinicalTrials.gov Identifier:

NCT00873483

EudraCT Number:

Not Available

EU CT Number:

Not Available
US Ovulation Inhibition Study in Obese Women

Trial purpose

Birth Control Patch Study

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - Female subject requesting contraception
    - Age: 18 - 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
    - Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
    - History of regular cyclic menstrual periods
    - Willingness to use non-hormonal methods of contraception during the entire study.
  • - Pregnancy or lactation (less than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment)
    - Hypersensitivity to any ingredient of the study drug
    - Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
    - Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug (e.g., known skin disease with suspected alteration of dermal absorption or poor adherence of the patch such as psoriasis)
    - Any disease or condition that may worsen under hormonal treatment.

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

Additional Information

Click here to find results for studies related to Bayer Healthcare products.