NCT01638923

Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding

A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled, 7 Cycle Duration (196 Days), Phase 3 Study to Investigate the Efficacy and Safety of Oral Estradiol Valerate / Dienogest Tablets for the Treatment of Heavy Menstrual Bleeding

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 339 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding

Conditions

• Metrorrhagia

Interventions

Type	Name	Description
DRUG	EV/DNG (Qlaira, Natazia, BAY86-5027)	2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placebo. A blister card consists of 28 pills, taken orally once a day for 7 cycles of 28 days each.
DRUG	placebo	Matching placebo to be taken orally daily for 7 cycles of 28 days each.

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-07-12
• Last updated: 2015-07-10

Locations

41 sites across 6 countries: China, Philippines, Russia, Singapore, Taiwan, Thailand