CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Estradiol/Norethindrone acetate +1 moredrug
Likely dose
Estradiol/Norethindrone acetate 0.5 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/NCT01157182
NCT01157182Phase 1Completed
CompareCT.gov

A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg Versus Activella® (1 mg Estradiol/0.5 mg Norethindrone Acetate) Tablets in Normal, Healthy, Post-Menopausal Female Subjects

Teva Pharmaceuticals USA·interventional·Posted Jul 5, 2010·Updated Dec 17, 2010

In Brief

A Phase 1 clinical trial evaluating Estradiol/Norethindrone acetate and Activella® for Healthy. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets under fasting conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 5, 2010
Enrollment StartFeb 1, 2007
Primary CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.0 years ago

Interventions

Estradiol/Norethindrone acetatedrug

1/0.5 mg Tablets

Activella®drug

1/0.5 mg Tablets