CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Drospirenone/Ethinyl Estradiol (Gianvi®) +1 moredrug
Likely dose
Drospirenone/Ethinyl Estradiol (Gianvi®) 3 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/NCT01182194
NCT01182194Phase 1Completed
CompareCT.gov

A Relative Bioavailability Study of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets Under Fasting Conditions.

Teva Pharmaceuticals USA·interventional·Posted Aug 16, 2010·Updated Dec 8, 2010

In Brief

A Phase 1 clinical trial evaluating Drospirenone/Ethinyl Estradiol (Gianvi®) and YAZ® for Healthy. Completed, enrolled 32 participants across 1 site.

Detailed Summary

This study was designed to compare the relative bioavailability (rate and extent of absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablet) in healthy, adult subjects administered under fasting conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 16, 2010
Enrollment StartJun 1, 2006
Primary CompletionAug 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.9 years ago

Interventions

Drospirenone/Ethinyl Estradiol (Gianvi®)drug

3 mg/0.02 mg Tablets

YAZ®drug

3 mg/0.02 mg Tablets