CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 8 enrolled
Drug / intervention
TSEC (Tissue-selective estrogen complexes) +1 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.

Search/NCT02274571
NCT02274571Early Ph 1Completed

Tissue Selective Estrogen Complex to Prevent Metabolic Dysfunction in Women

Pennington Biomedical Research Center·interventional·Posted Oct 24, 2014·Updated Jun 4, 2025

In Brief

A Early Phase 1 clinical trial evaluating TSEC (Tissue-selective estrogen complexes) and Placebo for Menopause. Completed, enrolled 8 participants across 1 site.

Detailed Summary

The purpose of this study is to find out if a novel drug approved by the Food and Drug Administration \[Duavee™, Pfizer, Inc\] for treatment of postmenopausal symptoms (vaginal dryness and hot flashes) and prevention of osteoporosis also improves insulin sensitivity by decreasing body fat especially in your liver. DUAVEE™ (Conjugated Estrogens/Bazedoxifene) is a new prescription medicine that contains a mixture of estrogen (the main female hormone made by the ovaries) and bazedoxifene, which is FDA approved. For over 60 years, estrogens have been used as hormonal treatments to help manage hot flashes and help prevent postmenopausal bone loss. But in the treatment of postmenopausal women, the use of estrogens alone can increase the risk of developing cancer of the uterus. So estrogens have been traditionally paired with a progestin to decrease the risk of hyperplasia (the thickening of the lining of the uterus), which can be a precursor to cancer. DUAVEE™ uses bazedoxifene, a selective estrogen receptor modulator (SERM), in place of a progestin to help protect the uterus against thickening of the uterus that may result from estrogens alone. In this study, you will get either DUAVEE™ or the placebo (a "dummy pill" that may look like medicine but contains no active medication) first and then switch to the other pill.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 24, 2014
Enrollment StartSep 1, 2015
Primary CompletionApr 11, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.7 years ago

Interventions

TSEC (Tissue-selective estrogen complexes)drug

Duavee™, combination of CE(conjugated equine estrogens) and BZA (bazedoxifene)

Placeboother

non active