US Ovulation Inhibition Study in Obese Women
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
1 other identifier
interventional
173
1 country
6
Brief Summary
Birth Control Patch Study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2009
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2009
CompletedFirst Posted
Study publicly available on registry
April 1, 2009
CompletedStudy Start
First participant enrolled
April 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2010
CompletedApril 8, 2021
April 1, 2021
10 months
March 31, 2009
April 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determination of Hoogland Scores
Treatment Cycles 2 & 3
Secondary Outcomes (3)
Laboratory values for E2, progesterone, FSH and LH
Pretreatment & regularly during Treatment Cycles 1, 2, 3
Endometrial thickness
Pretreatment & regularly during Treatment Cycles 1, 2, 3
Follicle size
Pretreatment & regularly during Treatment Cycles 1, 2, 3
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
0.55 mg ethinyl estradiol \& 2.1 mg gestodene, 21 days for 3 cycles
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (6)
Unknown Facility
Tucson, Arizona, 85712, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
Sandy Springs, Georgia, 30328, United States
Unknown Facility
Philadelphia, Pennsylvania, 19114, United States
Unknown Facility
Houston, Texas, 77054, United States
Unknown Facility
Seattle, Washington, 98105, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2009
First Posted
April 1, 2009
Study Start
April 30, 2009
Primary Completion
March 3, 2010
Study Completion
March 3, 2010
Last Updated
April 8, 2021
Record last verified: 2021-04