NCT00673686

Study to Investigate the Effect of Missed Pills on Follicular Development in Two Application Regimens of SH T 00186 D

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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 contraceptive pills was measured by ultrasound comparison of follicular size and other parameters which indicate how far ovulation might be.

Conditions

• Contraceptives, Oral

Interventions

Type	Name	Description
DRUG	YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)	SH T 00186 D in a 24-day regimen, i.e., 24 verum tablets, 4 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each
DRUG	Yasminelle (SH T 00186 D)	SH T 00186 D in a 21-day regimen, i.e., 21 verum tablets, 7 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each

Timeline

• Start date: 2004-05-01
• Primary completion: 2005-02-01
• Completion: 2005-02-01
• First posted: 2008-05-07
• Last updated: 2014-10-13

Locations

1 site across 1 country: Netherlands