NCT00909857

Effect on Primary Dysmenorrhea

A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 507 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 14 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.

Conditions

• Primary Dysmenorrhea

Interventions

Type	Name	Description
DRUG	Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)	Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval
DRUG	Ethinyl estradiol, Levonorgestrel (Miranova)	Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval
DRUG	Placebo Match to SH T00658ID	Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
DRUG	Placebo Match to SH D593B	Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-05-29
• Last updated: 2015-08-24
• Results posted: 2012-02-27

Locations

41 sites across 6 countries: United States, Canada, Chile, Germany, Italy, Philippines