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A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms

NCT01942668 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1845

Last updated 2019-05-06

Study results available
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Summary

This study will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter trial of postmenopausal subjects with an intact uterus.

Conditions

Interventions

DRUG

Estradiol

DRUG

Progesterone

DRUG

Placebo

Sponsors & Collaborators

  • TherapeuticsMD

    lead INDUSTRY

Principal Investigators

  • Sebastian Mirkin, MD · TherapeuticsMD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-05
Primary Completion
2016-10-28
Completion
2016-10-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01942668 on ClinicalTrials.gov