At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 92 enrolled
Drug / intervention
Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) +2 moredrug
Likely dose
Not stated in 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.
A Double Blind, Randomized, Active-control Study to Evaluate Effects of Drospirenone/Estradiol (Angeliq) and Medroxyprogesterone Acetate/Conjugated Equine Estrogen (Prempro) on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
In Brief
A Phase 2 clinical trial evaluating Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) and SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM) for Postmenopause and 2 related conditions. Completed, enrolled 92 participants across 9 sites.
Detailed Summary
The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopause, Hypertension, Pre-Hypertension
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedJan 2007
Primary CompletionSep 2008
TodayJul 2026
First PostedJan 11, 2007
Enrollment StartJan 1, 2007
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.5 years ago
Interventions
Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)drug
SH K 00641 A -Active study medication encapsulated tablet
Drospirenone/17ß-estradiol (Angeliq, BAY86-4891)drug
SH K 00641 B - Active study medication encapsulated tablet
SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)drug
Active control encapsulated tablet