Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Menopause, sponsored by TherapeuticsMD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
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
| Field | Value |
|---|---|
| Enrollment Target | 1,845 participants |
| Start Date | 2013-08-05 |
| Est. Completion | 2016-10-28 |
| Phase | Phase 3 |
What the finished NCT01942668 record still lists
NCT01942668 is an interventional study that assigns participants to a tested intervention. Its 1,845 participants enrollment target places it among the larger protocols in the corpus, below the 9,360-participant average among 54 other Menopause trials with a reported enrollment target (80% lower).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
Similar trials for Menopause
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01942668's enrollment target sits among peer trials
1,845 2nd of 54 the highest of 54 other Menopause trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Menopause trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women
COMPLETED · Phase 3
-
Therapy to Prevent Sexual Pain in Breast Cancer Survivors
COMPLETED · Phase 3
-
Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function
RECRUITING
-
Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women
RECRUITING
-
Apple Women's Health Study
RECRUITING
-
Hot Flashes and Neurovascular Function in Women
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06465810 · 1,850 participants
Non-interventional Study of Patients With Transthyretin (ATTR) Amyloidosis
- NCT06580080 · 1,850 participants · NA
Evaluation of Are You Ready?
- NCT06740630 · 1,840 participants · Phase 3
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age
- NCT07104240 · 1,836 participants · NA
A Vaccine Promotion Package (TweenVax) to Improve Adolescent HPV Vaccination, TweenVax Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI