CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,887 enrolled
Drug / intervention
EE20/DRSP (BAY86-5300) +2 moredrug
Likely dose
EE20/DRSP (BAY86-5300) 0.02 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00567164
NCT00567164Phase 3Completed
CompareCT.gov

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

Bayer·interventional·Posted Dec 4, 2007·Updated Mar 12, 2014

In Brief

A Phase 3 clinical trial evaluating EE20/DRSP (BAY86-5300) and EE20/DRSP (YAZ, BAY86-5300) for Contraception and 2 related conditions. Completed, enrolled 1,887 participants across 85 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception, Ovulation Inhibition, Contraceptives, Oral
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 4, 2007
Enrollment StartOct 1, 2007
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.6 years ago

Interventions

EE20/DRSP (BAY86-5300)drug

Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone

EE20/DRSP (BAY86-5300)drug

Combination tablet containing 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone

EE20/DRSP (YAZ, BAY86-5300)drug

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)