check_circleStudy Completed
Contraception, Ovulation inhibition
Bayer Identifier:
14348
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Inhibition of ovulation and pharmacokinetics of transdermal ethinylestradiol (EE) and Gestodene (GSD)
Trial purpose
Investigation of two transdermal hormone patch formulations for contraception regarding inhibition of ovulation over a period of 3 treatment cycles in healthy young female volunteers
Key Participants Requirements
Sex
FemaleAge
18 - 35 YearsTrial summary
Enrollment Goal
108Trial Dates
June 2009 - April 2010Phase
Phase 2Could I Receive a placebo
NoProducts
Gestodene/EE Patch (BAY86-5016)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Dinox GmbH Berlin | Berlin, 10115, Germany |
Completed | Bayer Schering Pharma AG | Berlin, 13353, Germany |
Primary Outcome
- The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3date_rangeTime Frame:4 monthsenhanced_encryptionyesSafety Issue:
Secondary Outcome
- The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3date_rangeTime Frame:4 monthsenhanced_encryptionyesSafety Issue:
- Course of gonadotropins (FSH, LH, P, E2)date_rangeTime Frame:4 monthsenhanced_encryptionyesSafety Issue:
- Endometrial thickness and Follicle sizedate_rangeTime Frame:4 monthsenhanced_encryptionyesSafety Issue:
- Pharmacokinetics of Ethinylestradiol (EE), Gestodene (GSD) and SHBG in treatment cycles 2 and 3date_rangeTime Frame:4 Monthsenhanced_encryptionyesSafety Issue:
- Cervical effects (Insler Score) for determination of hormonal effects on the cervix and the cervical mucus during pre-treatment cycle and treatment cycle 3date_rangeTime Frame:4 Monthsenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2Additional Information
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