Status:
COMPLETED
Study to Investigate the Effect of Missed Pills on Follicular Development in Two Application Regimens of SH T 00186 D
Lead Sponsor:
Bayer
Conditions:
Contraceptives, Oral
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief Summary
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 contra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00673686
Start Date
May 1 2004
End Date
February 1 2005
Last Update
October 13 2014
Active Locations (1)
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1
Groningen, Netherlands, 9713 GZ