Trial Condition(s):
Contraceptives, Oral
Study to investigate the effect of missed pills on follicular development in two application regimens of SH T 00186 D
Bayer Identifier:
91377
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Healthy women aged 18 to 35 years inclusive (smokers aged up to 30 years inclusive) - No contraindications for combined oral contraceptive (COC) use - Follicular diameter of greater-equal than 15 mm on visit 6 (admission to treatment), or an observed ovulation during pretreatment cycle
Exclusion Criteria
- Pregnancy or lactation- Substantial overweight, i.e., body mass index (BMI) > 30, - Known hypersensitivity to any of the study drug ingredients - Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study, or the interpretation of the results
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Dinox B.V. Groningen, Netherlands, 9713 GZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Single center, double-blind, randomized study to compare the effect of SH T 00186 D on follicular development in a 24-day regimen versus a 21-day regimen in healthy female volunteers
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Hoogland scores in cycles 2 and 3Timeframe: Treatment cycles 2 and 3 (treatment weeks 5-12)
Secondary Outcome
- Follicle sizeTimeframe: Treatment cycles 2 and 3 (treatment weeks 5-12
- Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormoneTimeframe: Treatment cycles 2 and 3 (treatment weeks 5-12
- Endometrial thicknessTimeframe: Treatment cycles 2 and 3 (treatment weeks 5-12
- Cervical mucusTimeframe: Treatment cycles 2 and 3 (treatment weeks 5-12
Additional Information
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