check_circleStudy Completed
Contraception
Bayer Identifier:
15264
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Investigation of three contraceptive hormone patches in regard to inhibition of ovulation following application over 3 treatment cycles in healthy, young women.
Trial purpose
The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals.
With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.
With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.
Key Participants Requirements
Sex
FemaleAge
18 - 35 YearsTrial summary
Enrollment Goal
173Trial Dates
September 2010 - August 2011Phase
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 | Dinox B.V. | Groningen, 9713 GZ, Netherlands |
Primary Outcome
- Hoogland score to evaluate the inhibition of ovulationdate_rangeTime Frame:After 2 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesteronedate_rangeTime Frame:After 2 monthsenhanced_encryptionNoSafety Issue:
- Follicle size measured by transvaginal ultrasound examinationdate_rangeTime Frame:After 2 monthsenhanced_encryptionNoSafety Issue:
- Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)date_rangeTime Frame:After 2 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
3Additional Information
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