CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 662 enrolled
Drug / intervention
0.25mg DRSP / 0.5mg E2 (BAY86-4891) +1 moredrug
Likely dose
0.25mg DRSP / 0.5mg E2 (BAY86-4891)from 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/NCT00522873
NCT00522873Phase 3Completed
CompareCT.gov

A Double-blind, Randomized, Multi-center Study to Investigate the Endometrial Safety of a Continuous, Combined, Oral Estrogen/Progestin Preparation (17b-estradiol [E2] / Drospirenone [DRSP]) and to Compare the Bleeding Pattern of Subjects Treated With E2 / DRSP With the Bleeding Pattern of Subjects Treated With E2 / Norethisterone Acetate (NETA) When Used for Hormone Therapy (HT) for 1 Year in Post-menopausal Women

Bayer·interventional·Posted Aug 30, 2007·Updated Dec 31, 2014

In Brief

A Phase 3 clinical trial evaluating 0.25mg DRSP / 0.5mg E2 (BAY86-4891) and 0.5mg NETA / 1.0mg E2 (Activella) for Postmenopause. Completed, enrolled 662 participants across 59 sites in 8 countries.

Detailed Summary

The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopause
CountriesArgentina, Austria, Brazil, Denmark, Italy, Mexico, Russia, United States
CollaboratorsLaboratorium für Klinische Forschung, Diagnostic Cytology Laboratory, University of California, San Francisco

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 30, 2007
Enrollment StartAug 1, 2007
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.8 years ago

Interventions

0.25mg DRSP / 0.5mg E2 (BAY86-4891)drug

One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle).

0.5mg NETA / 1.0mg E2 (Activella)drug

One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).