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:

NCT00673686

EudraCT Number:

Not Available

Study Completed

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
105
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Dinox B.V.

Groningen, Netherlands, 9713 GZ

Status
Completed
 

Trial Design