check_circleStudy Completed

Contraception, Ovulation Inhibition, Contraceptives, Oral

Study to compare cycle control and safety of the oral contraceptive SH T 00186 D (0.02 mg Ethinylestradiol and 3 mg Drospirenone) in a 21-day regimen vs. Mercilon®

Trial purpose

Please see attached Study Results Summary below.

Key Participants Requirements

Sex

N/A

Age

N/A

Trial summary

Enrollment Goal
441
Trial Dates
February 2001 - May 2002
Phase
Phase 3
Could I Receive a placebo
N/A
Products
Yasminelle (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteer
N/A

Primary Outcome

Secondary Outcome

Trial design

Multi-center, open, randomized, parallel group comparison of cycle control and safety of the oral contraceptive SH T 00186 D (Ethinylestradiol-ß-Cyclodextrin Clathrate (equivalent to 0.02 mg ethinylestradiol) and 3 mg drospirenone) in a 21-day regimen vs. Mercilon® for 7 cycles in 400 healthy female volunteers
Trial Type
Interventional
Intervention Type
N/A
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A