stop_circleTerminated/Withdrawn
Contraception, Ovulation Inhibition
Bayer Identifier:
91558
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Inhibition of ovulation, patch, ethinylestradiol and gestodene
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
17Trial Dates
August 2008 - February 2009Phase
Phase 2Could I Receive a placebo
NoProducts
Gestodene/EE Patch (BAY86-5016)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Dinox GmbH Berlin | Berlin, 10115, Germany |
Terminated | Bayer Schering Pharma AG - Clin. Pharm. Berlin | Berlin, 13342, Germany |
Terminated | Landesamt für Gesundheit und Soziales | Berlin, 10707, 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 3.date_rangeTime Frame:4 monthenhanced_encryptionyesSafety Issue:
Secondary Outcome
- Assessment of ovarian activity during treatment cycle2 and 3 (Hoogland score)date_rangeTime Frame:4 monthenhanced_encryptionyesSafety Issue:
- Course of gonadotropins (FSH, LH, P, E2)date_rangeTime Frame:4 monthenhanced_encryptionyesSafety Issue:
- Endometrial thicknessdate_rangeTime Frame:4 monthenhanced_encryptionyesSafety Issue:
- Follicle sizedate_rangeTime Frame:4 monthenhanced_encryptionyesSafety Issue:
- Pharmacokinetics of EE, GSD and SHBG in treatment cycles 2 and 3date_rangeTime Frame:4 monthenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2Additional Information
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