check_circleStudy Completed
Contraceptives, Oral
Bayer Identifier:
91377
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study to investigate the effect of missed pills on follicular development in two application regimens of SH T 00186 D
Trial purpose
In this study a comparison was made on the influence of missing pills on follicular ripening. By missing a given number of pills, an effect on "contraceptive robustness" of the two investigated contraceptive pills was measured by ultrasound comparison of follicular size and other parameters which indicate how far ovulation might be.
Key Participants Requirements
Sex
FemaleAge
18 - 35 YearsTrial summary
Enrollment Goal
105Trial Dates
May 2004 - February 2005Phase
Phase 2Could I Receive a placebo
NoProducts
YAZ (EE20/DRSP, BAY86-5300)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Dinox B.V. | Groningen, 9713 GZ, Netherlands |
Primary Outcome
- Hoogland scores in cycles 2 and 3date_rangeTime Frame:Treatment cycles 2 and 3 (treatment weeks 5-12)enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Follicle sizedate_rangeTime Frame:Treatment cycles 2 and 3 (treatment weeks 5-12enhanced_encryptionnoSafety Issue:
- Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormonedate_rangeTime Frame:Treatment cycles 2 and 3 (treatment weeks 5-12enhanced_encryptionnoSafety Issue:
- Endometrial thicknessdate_rangeTime Frame:Treatment cycles 2 and 3 (treatment weeks 5-12enhanced_encryptionnoSafety Issue:
- Cervical mucusdate_rangeTime Frame:Treatment cycles 2 and 3 (treatment weeks 5-12enhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2