NCT00805415

Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

Multicenter, Open-label, Randomized, Comparative Study to Evaluate Ovulation Inhibition With Two 4-phasic Oral Contraceptive Regimens Containing Estradiol Valerate and Dienogest Applied Daily for Three Cycles to 200 Healthy Female Volunteer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.

Conditions

• Ovulation Inhibition

Interventions

Type	Name	Description
DRUG	EV/DNG (Qlaira, BAY86-5027, SH T00658K)	Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg
DRUG	EV/DNG (SH T00658L)	Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg

Timeline

• Start date: 2003-03-01
• Primary completion: 2004-02-01
• Completion: 2004-02-01
• First posted: 2008-12-09
• Last updated: 2011-07-15

Locations

2 sites across 2 countries: Germany, Netherlands