At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 96 enrolled
Drug / intervention
Estradiol +4 moredrug
Likely dose
Estradiol 1 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.
Effects of Estradiol and Soy on Menopausal Symptoms
In Brief
A Phase 2 clinical trial evaluating Soy Phytoestrogen, Estradiol, and 3 other interventions for Menopause and Hot Flashes. Completed, enrolled 96 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the effects of oral estradiol and soy phytoestrogens on anxiety, stress responsivity and cognition in perimenopausal women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause, Hot Flashes
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartDec 2009
Primary CompletionMay 2015
TodayJul 2026
First PostedOct 19, 2009
Enrollment StartDec 1, 2009
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 16.7 years ago
Interventions
Soy Phytoestrogendietary
Novasoy® pill (55 mg)
Estradioldrug
Estradiol pill (1 mg)
Medroxyprogesterone Acetate (MPA)drug
medroxyprogesterone acetate (MPA) (10mg)
Soy Placebodrug
oral placebo pill (0mg Soy Phytoestrogen)
MPA Placebodrug
oral placebo pill (0mg MPA)