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NCT01942668 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Menopause, sponsored by TherapeuticsMD.

Completed
Registry status
Phase 3
Development phase
1,845
Enrollment target
20
Study locations

NCT01942668 is a Phase 3 study of Menopause that has completed, run by TherapeuticsMD. The registered enrollment target is 1,845 participants, below the 9,360-participant average among 54 other Menopause trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT01942668, a Phase 3 study of Menopause, has completed, sponsored by TherapeuticsMD.

COMPLETED
Registry status
Phase 3
Development phase
1,845 participants
Enrollment target
20
Study locations

Study Summary

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

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Progesterone
  • DRUG Estradiol

Study Locations (20)

California

  • Sutter East Bay Medical Foundation - Berkeley
  • Grossmont Center for Clinical Research - La Mesa
  • Futura Research - Norwalk
  • Medical Center for Clinical Research - San Diego
  • Women's Health Care Research Corp. - San Diego
  • Radiant Research, Inc. - Santa Rosa
  • Diablo Clinical Research - Walnut Creek

Alabama

  • Simon Williamson Clinic - Birmingham
  • Medical Affiliated Research Center - Huntsville
  • Coastal Clinical Research - Mobile
  • Mobile Ob-Gyn, P.C. - Mobile
  • Montgomery Women's Health - Montgomery

Arizona

  • Advanced Research Associates - Glendale
  • Cactus Clinical Research - Mesa
  • Precision Trials - Phoenix
  • Radiant Research (Tucson) - Tucson
  • Visions Clinical Research Tucson - Tucson

Colorado

  • Downtown Women's Healthcare - Denver
  • Horizon's Clinical Research Center - Denver

Arkansas

  • Health Star Research, LLC - Hot Springs

Trial Details

FieldValue
Enrollment Target 1,845 participants
Start Date 2013-08-05
Est. Completion 2016-10-28
Phase Phase 3

Sponsor

TherapeuticsMD

5 total trials

What the Registry Record Tells You About NCT01942668

The ClinicalTrials.gov registry entry for NCT01942668 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,845 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 9,360-participant average among 54 other Menopause trials with a reported enrollment target (80% lower). The listed sponsor is TherapeuticsMD, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Menopause appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01942668 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT01942668 about?

NCT01942668 is a clinical study titled "A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms". This study will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter trial of postmenopausal subjects with an intact uterus.

What is the current status of trial NCT01942668?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,845 participants. The study started on 2013-08-05. Estimated completion is 2016-10-28.

What conditions does trial NCT01942668 study?

This clinical trial studies the following conditions: Menopause.

What interventions are being tested in trial NCT01942668?

The interventions under investigation include: Placebo (DRUG), Progesterone (DRUG), Estradiol (DRUG).

Who is sponsoring clinical trial NCT01942668?

This trial is sponsored by TherapeuticsMD, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01942668 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.