At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 249 enrolled
Drug / intervention
Estradiol acetate +2 moredrug
Likely dose
Estradiol acetate 0.9 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.
A Multicenter, Double-Blind, Controlled, Randomized Study to Compare the Efficacy in Relief of Hot Flushes in Women Receiving Oral Estradiol Acetate Tablets, Oral Estradiol Tablets or Oral Conjugated Equine Estrogens
In Brief
A Phase 3 clinical trial evaluating Estradiol acetate, Estradiol, and 1 other intervention for Hormone Replacement Therapy. Completed, enrolled 249 participants across 32 sites.
Detailed Summary
Multicenter, double-blind, controlled, parallel group, randomized study to compare the clinical benefit of Estradiol acetate tablets, estradiol tablets and conjugated equine estrogen tablets, each administered orally, once daily, to postmenopausal women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHormone Replacement Therapy
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2003
Primary CompletionSep 2003
First PostedFeb 2010
TodayJul 2026
First PostedFeb 18, 2010
Enrollment StartFeb 1, 2003
Primary CompletionSep 1, 2003
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.4 years ago
Interventions
Estradiol acetatedrug
Tablet containing 0.9 mg E3A, daily oral administration.
Estradioldrug
Tablet containing 1 mg estradiol, daily oral administration.
Conjugated equine estrogensdrug
Tablet containing 0.625 mg CEE, daily oral administration.