NCT00567164

Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ

A Multicenter, Open-label, Three-arm, Active-controlled Study to Assess the Efficacy and Safety of the Oral Contraceptive SH T00186D (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) in Two Flexible Extended Regimens and a Conventional Regimen of YAZ in 1756 Healthy Females for 1 Year

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,887 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether the study drug is safe and effective.

Detailed description

The primary efficacy parameter is the number of observed unintended pregnancy during 1 year of treatment. Secondary efficacy parameter include bleeding parameters and menstrual related symptoms Safety parameters included assessment of adverse events, laboratory evaluations.

Conditions

• Contraception
• Ovulation Inhibition
• Contraceptives, Oral

Interventions

Type	Name	Description
DRUG	EE20/DRSP (BAY86-5300)	Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
DRUG	EE20/DRSP (BAY86-5300)	Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
DRUG	EE20/DRSP (YAZ, BAY86-5300)	Fixed package per cycle containing combination tablets containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone (24 per cycle) + tablets without active substance (4 per cycle)

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2007-12-04
• Last updated: 2014-03-12
• Results posted: 2014-03-12

Locations

85 sites across 1 country: United States