CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 735 enrolled
Drug / intervention
0.5mg DRSP / 0.5mg E2 (BAY86-4891) +3 moredrug
Likely dose
0.5mg 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/NCT00446199
NCT00446199Phase 3Completed
CompareCT.gov

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Lowest Effective Dose of Combinations of Oral Drospirenone and 17 Beta-Estradiol for the Relief of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women Over a Treatment Period of 12 Weeks

Bayer·interventional·Posted Mar 12, 2007·Updated May 6, 2015

In Brief

A Phase 3 clinical trial evaluating 0.5mg DRSP / 0.5mg E2 (BAY86-4891), 0.25mg DRSP / 0.5mg E2 (BAY86-4891), and 2 other interventions for Vasomotor Symptoms and Hot Flashes. Completed, enrolled 735 participants across 76 sites.

Detailed Summary

The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVasomotor Symptoms, Hot Flashes
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 12, 2007
Enrollment StartMar 1, 2007
Primary CompletionOct 1, 2008
Study CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.3 years ago

Interventions

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

One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).

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

One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle).

Estradiol (E2 0.3mg)drug

One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle).

Placebodrug

Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).