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

NCT01638923 Phase 3 COMPLETED

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

Details

Lead sponsor	Bayer
Phase	Phase 3
Status	COMPLETED
Enrolment	339
Start date	2012-06
Completion	2015-06

Conditions

• Metrorrhagia

Interventions

• EV/DNG (Qlaira, Natazia, BAY86-5027)
• placebo

Primary outcomes

• Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days — 90 day baseline period and 90 days during treatment period

Countries

China, Philippines, Russia, Singapore, Taiwan, Thailand