check_circleStudy Completed
Ovulation Inhibition
Bayer Identifier:
91271
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Ovulation inhibition of two 4-phasic oral contraceptive regimens
Trial purpose
The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.
Key Participants Requirements
Sex
FemaleAge
18 - 35 YearsTrial summary
Enrollment Goal
209Trial Dates
March 2003 - February 2004Phase
Phase 2Could I Receive a placebo
NoProducts
Natazia/Qlaira (EV/DNG, BAY86-5027)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
- Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)date_rangeTime Frame:Treatment cycles 2 and 3enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation)date_rangeTime Frame:Treatment cycles 2 or 3enhanced_encryptionnoSafety Issue:
- Measurements of endometrial thicknessdate_rangeTime Frame:Treatment cycles 2 and 3enhanced_encryptionnoSafety Issue:
- Visibility of cervical mucusdate_rangeTime Frame:Treatment cycles 2 and 3enhanced_encryptionnoSafety Issue:
- Ovarian activity (Hoogland score)date_rangeTime Frame:Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3enhanced_encryptionnoSafety Issue:
- Measurements of follicle sizedate_rangeTime Frame:Treatment cycles 2 and 3enhanced_encryptionNoSafety Issue:
- Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol)date_rangeTime Frame:Treatment cycles 2 and 3enhanced_encryptionNoSafety Issue:
- Compliancedate_rangeTime Frame:Throughout whole studyenhanced_encryptionNoSafety Issue:
- Medical, surgical and medication history, concomitant medication, general physical and gynecological examination, cervical smear, pregnancy test, adverse events, safety laboratory determinations, cycle control, vital signsdate_rangeTime Frame:Various timepoint throughout the studyenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2