NCT01076582

Comparative Trial in Hormone Withdrawal Associated Symptoms

A Multi-centre, Randomized, Double-blind, Active Control, Parallel-group, 2-arm Study to Investigate the Effect of Ethinylestradiol / Drospirenone (0.02 mg/3 mg) Oral Contraception in a 24/4 Regimen Compared to Ethinylestradiol / Desogestrel (0.02 mg/0.15 mg) Oral Contraception in a 21/7 Regimen on Hormone Withdrawal Associated Symptoms in Otherwise Healthy Women After 4 Cycles of Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 592 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This clinical research study will examine whether an oral contraceptive pill taken with a monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days after 4 cycles of treatment.

Conditions

• Oral Contraceptive

Interventions

Type	Name	Description
DRUG	EE20/DRSP (YAZ, BAY86-5300)	4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DRSP 3 mg) daily for 24 days followed by 1 placebo tablet daily for 4 days
DRUG	Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)	4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DSG 0.15 mg) daily for 21 days followed by 1 placebo tablet daily for 7 days

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-02-26
• Last updated: 2014-10-28

Locations

44 sites across 14 countries: Argentina, Chile, Colombia, Czechia, Germany, Italy, Philippines, Portugal, Russia, South Korea, Switzerland, Thailand, United Kingdom, Venezuela