NCT02617537

To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea

A Multinational, Double-blind, Randomized, Placebo-controlled, Parallel-group Clinical Study to Investigate the Efficacy and Safety of the Oral Hormonal Contraceptive BAY 86-5300 (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) Over 16 Weeks for the Treatment of Women With Dysmenorrhea

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate the safety and efficacy of (0.02 mg EE as betadex clathrate \[β-CDC\]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a placebo-controlled comparative study

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DRUG	EE20/DRSP(YAZ,BAY86-5300)	0.02 mg EE (β-CDC)/3 mg DRSP for 24 days and placebo tablets for 4 days per 28-day intake cycle
DRUG	Placebo	Matching placebo tablets for 28 days per 28-day intake cycle

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-09-01
• Completion: 2017-10-01
• First posted: 2015-12-01
• Last updated: 2016-02-17