A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms
REPLENISH
A Phase 3 Study Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms in Postmenopausal Women With an Intact Uterus
2 other identifiers
interventional
1,845
1 country
119
Brief Summary
This study will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter trial of postmenopausal subjects with an intact uterus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2013
Typical duration for phase_3
119 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 5, 2013
CompletedFirst Submitted
Initial submission to the registry
September 5, 2013
CompletedFirst Posted
Study publicly available on registry
September 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2016
CompletedResults Posted
Study results publicly available
May 6, 2019
CompletedMay 6, 2019
April 1, 2019
3.2 years
September 5, 2013
November 27, 2018
April 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS)
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.
Baseline and Week 4
Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS)
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12. 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.
Baseline and Week 12
Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS)
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = \[(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 4
Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS)
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = \[(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3\] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 12
Primary Safety Endpoint: Endometrial Protection - Hyperplasia
Endometrial biopsies centrally evaluated by 2 primary pathologists using criteria from Blaustein's Pathology text. Pathologists classified bx into 1 of following 3 categories: Cat.1: Non-endometrial malignancy/non-hyperplasia; Cat.2: Endometrial hyperplasia; Cat.3: Endometrial malignancy. Consensus reached when 2 primary pathologist agreed on any of above categories; if primary pathologists disagreed on presence of hyperplasia, result of 3rd pathologist was utilized and final decision regarding presence of hyperplasia was based on diagnosis of majority. If all 3 reads disparate, final diagnosis based on most severe dx. Incidence rate calculated as: I=A/B where I=incidence rate at M12 evaluation, A=all new subjects with biopsies positive for endometrial hyperplasia during study but post-Baseline, B=all subjects w/biopsies following M11 meeting criteria specified plus all subjects w/biopsies positive for endometrial hyperplasia by any pathologists before M11.
Baseline and Month 12
Secondary Outcomes (205)
Endometrial Protection - Hyperplasia
Baseline and Month 12
Frequency of Moderate to Severe Vasomotor Symptoms - Week 1 (MITT-VMS)
Baseline and Week 1
Frequency of Moderate to Severe Vasomotor Symptoms - Week 2 (MITT-VMS)
Baseline and Week 2
Frequency of Moderate to Severe Vasomotor Symptoms - Week 3 (MITT-VMS)
Baseline and Week 3
Frequency of Moderate to Severe Vasomotor Symptoms - Week 4 (MITT-VMS)
Baseline and Week 4
- +200 more secondary outcomes
Study Arms (5)
Treatment 1
EXPERIMENTALCombined Estradiol 1 mg / Progesterone 100 mg softgel capsule formulation and placebo taken orally once a day for twelve months.
Treatment 2
EXPERIMENTALCombined Estradiol 0.5 mg / Progesterone 100 mg softgel capsule formulation and placebo taken orally once a day for twelve months.
Treatment 3
EXPERIMENTALCombined Estradiol 0.5 mg / Progesterone 50 mg softgel capsule formulation and placebo, taken orally once a day for twelve months.
Treatment 4
EXPERIMENTALCombined Estradiol 0.25 mg / Progesterone 50 mg softgel capsule formulation and placebo, taken orally once a day for twelve months.
Placebo
PLACEBO COMPARATORTwo Placebo softgel capsules taken orally once a day for twelve months.
Interventions
Eligibility Criteria
You may qualify if:
- Be a female between the ages of 40 and 65 years (at the time of randomization) who is willing to participate in the study, as documented by signing the informed consent form.
- Be a postmenopausal woman with an intact uterus and a Screening serum estradiol level of ≤50 pg/mL. Postmenopausal is defined herein as:
- ≥ 12 months of spontaneous amenorrhea, or
- at least 6 months of spontaneous amenorrhea with a Screening serum FSH level of \>40 mIU/ml, or
- ≥ 6 weeks postsurgical bilateral oophorectomy.
- Be seeking treatment or relief for vasomotor symptoms associated with menopause.
- To participate in the VMS Substudy, a subject must also report ≥7 moderate to severe hot flushes per day, or ≥50 per week, at the baseline assessment during Screening (subjects whose hot flushes are less frequent may still participate as non-Substudy subjects.
- Note: A minimum of 14 consecutive days of complete hot flush diary data are required during the baseline assessment at Screening, and these consecutive days must occur within the last 14 days prior to the Randomization visit (not counting the Randomization visit day itself). The most recent 7 consecutive days of data prior to randomization (Day -7 to Day -1) will be used to determine the baseline number of mild, moderate and severe hot flushes for each subject.
- Have a Body Mass Index (BMI) less than or equal to 34 kg/mP2P. (BMI values should be rounded to the nearest integer \[e.g., 34.4 rounds down to 34, while 26.5 rounds up to 27\]).
- Be willing to abstain from using products (other than study medication) that contain estrogen, progestin, or progesterone throughout study participation.
- Be judged by the principal or sub-investigator physician as being in otherwise generally good health based on a medical evaluation performed during the Screening period prior to the initial dose of study medication. The medical evaluation findings must include:
- a normal or non-clinically significant physical examination, including vital signs (sitting blood pressure, heart rate, respiratory rate and temperature). Sitting systolic blood pressure is ≤140 mmHg and diastolic blood pressure ≤90 mmHg at Screening. A subject may be taking up to two antihypertensive medications.
- a normal or non-clinically significant pelvic examination.
- a mammogram that shows no sign of significant disease (can be performed within previous 6 months prior to initial dose of study medication). Subjects must have a BI-RADS 1 or 2 to enroll in the study. An incomplete mammogram result, i.e. BI-RADS 0, is not acceptable. The site must obtain a copy of the official report for the subject's study file, and it must be verified that the mammogram itself is available if needed for additional assessment.
- a normal or non-clinically significant clinical breast examination. An acceptable breast examination is defined as no masses or other findings identified that are suspicious of malignancy.
- +2 more criteria
You may not qualify if:
- To participate in the study, a subject must NOT:
- Be currently hospitalized.
- Have a history of thrombosis of deep veins or arteries or a thromboembolic disorder.
- Have a history of coronary artery or cerebrovascular disease (e.g., myocardial infarction, angina, stroke, TIA).
- Have a history of a chronic liver or kidney dysfunction/disorder (e.g., Hepatitis C or chronic renal failure).
- Have a history of a malabsorption disorder (e.g., gastric bypass, Crohn's disease).
- Have a history of gallbladder dysfunction/disorders (e.g., cholangitis, cholecystitis), unless gallbladder has been removed.
- Have a history of diabetes, thyroid disease or any other endocrinological disease. (Subjects with diet-controlled diabetes or controlled hypothyroid disease at Screening are not excluded.)
- Have a history of estrogen-dependent neoplasia.
- Have a history of atypical ductal hyperplasia of the breast.
- Have a finding of clinically significant uterine fibroids at Screening.
- Have had a uterine ablation.
- Have a history of undiagnosed vaginal bleeding.
- Have any history of endometrial hyperplasia, melanoma, or uterine/endometrial, breast or ovarian cancer.
- Have any history of other malignancy within the last 5 years, with the exception of basal cell (excluded if within 1 year) or non-invasive squamous cell (excluded if within 1 year) carcinoma of the skin.
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TherapeuticsMDlead
Study Sites (119)
Simon Williamson Clinic
Birmingham, Alabama, 35211, United States
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
Coastal Clinical Research
Mobile, Alabama, 36608, United States
Mobile Ob-Gyn, P.C.
Mobile, Alabama, 36608, United States
Montgomery Women's Health
Montgomery, Alabama, 36117, United States
Advanced Research Associates
Glendale, Arizona, 85308, United States
Cactus Clinical Research
Mesa, Arizona, 85209, United States
Precision Trials
Phoenix, Arizona, 85032, United States
Radiant Research (Tucson)
Tucson, Arizona, 85712, United States
Visions Clinical Research Tucson
Tucson, Arizona, 85712, United States
Health Star Research, LLC
Hot Springs, Arkansas, 71913, United States
Sutter East Bay Medical Foundation
Berkeley, California, 94705, United States
Grossmont Center for Clinical Research
La Mesa, California, 91942, United States
Futura Research
Norwalk, California, 90650, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Women's Health Care Research Corp.
San Diego, California, 92111, United States
Radiant Research, Inc.
Santa Rosa, California, 95405, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Downtown Women's Healthcare
Denver, Colorado, 80209, United States
Horizon's Clinical Research Center
Denver, Colorado, 80220, United States
Red Rocks OB/Gyn
Lakewood, Colorado, 80228, United States
Clinical Research Consulting
Milford, Connecticut, 06460, United States
Coastal Connecticut Research
New London, Connecticut, 06320, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Nature Coast Clinical Research
Crystal River, Florida, 34429, United States
Clinical Physiology Associates
Fort Myers, Florida, 33916, United States
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research
Gainesville, Florida, 32607, United States
UF College of Medicine-Jacksonville, Dept. of Obstetrics and Gynecology
Jacksonville, Florida, 32207, United States
Suncoast Research
Margate, Florida, 33063, United States
Accelovance
Melbourne, Florida, 32934, United States
Suncoast Clinical Research, Inc
New Port Richey, Florida, 34652, United States
Segal Institute
North Miami, Florida, 33161, United States
Ideal Clinical Research
North Miami Beach, Florida, 33162, United States
Compass Research
Orlando, Florida, 32806, United States
Radiant Research (St. Petersburg)
Pinellas Park, Florida, 33781, United States
All Women's Healthcare of West Broward Discovery Clinical Research
Plantation, Florida, 33324, United States
Comprehensive Clinical Trials
West Palm Beach, Florida, 33409, United States
Radiant Research (Atlanta)
Atlanta, Georgia, 30328, United States
Women's Health Associates
Atlanta, Georgia, 30342, United States
Soapstone Center for Clinical Research
Decatur, Georgia, 30034, United States
Wake Research - Mount Vernon Clinical Research
Sandy Springs, Georgia, 30328, United States
Fellows Research Alliance
Savannah, Georgia, 31406, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Biofortis
Addison, Illinois, 60101, United States
Women's Health Practice
Champaign, Illinois, 61820, United States
Radiant Research (Chicago)
Chicago, Illinois, 60654, United States
The South Bend Clinic Granger
Granger, Indiana, 46530, United States
Davis Clinic
Indianapolis, Indiana, 46250, United States
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226, United States
Central Kentucky Research Associates
Lexington, Kentucky, 40509, United States
Bluegrass Clinical Research
Louisville, Kentucky, 40291, United States
Horizon Research Group
Eunice, Louisiana, 70535, United States
Maryland Center for Sexual Health
Lutherville, Maryland, 21093, United States
Quest Research Institute
Bingham Farms, Michigan, 48025, United States
Female Pelvic Medicine & Urogynecology
Grand Rapids, Michigan, 49503, United States
Beyer Research
Kalamazoo, Michigan, 49009, United States
Saginaw Valley Medical Research Group
Saginaw, Michigan, 48604, United States
Radiant Research (St. Louis)
St Louis, Missouri, 63141, United States
Billings Clinical Research
Billings, Montana, 59101, United States
Montana Health
Billings, Montana, 59102, United States
Women's Clinic of Lincoln
Lincoln, Nebraska, 68510, United States
Affiliated Clinical Research INC
Las Vegas, Nevada, 89113, United States
Affiliated Clinical Research
Las Vegas, Nevada, 89128, United States
Lawrence OB-GYN Clinical Research
Lawrenceville, New Jersey, 08648, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Bosque Women's Care
Albuquerque, New Mexico, 87109, United States
Southwest Clinical Research
Albuquerque, New Mexico, 87109, United States
Columbia University
New York, New York, 10032, United States
Suffolk OB/GYN
Port Jefferson, New York, 11777, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
Women's Wellness Clinic
Durham, North Carolina, 27713, United States
Carolina Medical Trials
High Point, North Carolina, 27262, United States
Centre OBGYN
Raleigh, North Carolina, 27607, United States
Wake County Research
Raleigh, North Carolina, 27612, United States
Lyndhurst Clinical Research
Salem, North Carolina, 27103, United States
Carolina Medical Trials
Winston-Salem, North Carolina, 27103, United States
Hawthorne Research
Winston-Salem, North Carolina, 27103, United States
Triad Ob-Gyn
Winston-Salem, North Carolina, 27103, United States
Lillestol Research
Fargo, North Dakota, 58103, United States
Radiant Research (Akron)
Akron, Ohio, 44311, United States
University of Cincinnati Physicians Company
Cincinnati, Ohio, 45267-0457, United States
Rapid Medical Research
Cleveland, Ohio, 44122, United States
Columbus Center for Women's Health Research
Columbus, Ohio, 43213, United States
HWC Women's Research Center
Englewood, Ohio, 45322, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Sunstone Medical Research
Medford, Oregon, 97504, United States
The Clinical Trial Center
Jenkintown, Pennsylvania, 19046, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, 15206, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Fellows Research Group
Bluffton, South Carolina, 29910, United States
Vista Clinical Research
Columbia, South Carolina, 29201, United States
Upstate Pharmaceutical Research
Greenville, South Carolina, 29615, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Chattanooga Medical Research
Chattanooga, Tennessee, 37404, United States
Volunteer Research Group/NOCCR
Knoxville, Tennessee, 37920, United States
DiscoveResearch, Inc.
Bryan, Texas, 77802, United States
Advanced Research Associates
Corpus Christi, Texas, 78414, United States
Research Across America
Dallas, Texas, 75234, United States
Brownstone Clinical Trials
Fort Worth, Texas, 76104, United States
Advances in Health
Houston, Texas, 77030, United States
The Women's Hospital of Texas
Houston, Texas, 77054, United States
TMC Life Research
Houston, Texas, 77054, United States
Protenium Clinical Research
Hurst, Texas, 76054, United States
MacArthur OB/GYN
Irving, Texas, 75062, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258, United States
NECRSA
Schertz, Texas, 78154, United States
PRO/ Salt Lake Women's Center
Draper, Utah, 84020, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
UVA/Midlife Health at North Ridge
Charlottesville, Virginia, 22908, United States
Clinical Research Center Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
Virginia Women's Center
Richmond, Virginia, 23233, United States
National Clinical Research-Richmond, Inc
Richmond, Virginia, 23294, United States
Tidewater Clinical Research
Virginia Beach, Virginia, 23456, United States
Seattle Women's Health Research, Gynecology
Seattle, Washington, 98105, United States
North Spokane Women's Health
Spokane, Washington, 99027, United States
Related Publications (16)
Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.
PMID: 8844630BACKGROUNDGerlinger C, Gude K, Hiemeyer F, Schmelter T, Schafers M. An empirically validated responder definition for the reduction of moderate to severe hot flushes in postmenopausal women. Menopause. 2012 Jul;19(7):799-803. doi: 10.1097/gme.0b013e31823de8ba.
PMID: 22228322BACKGROUNDSpritzer, K. L. & Hays, R. D. (2003, November). MOS Sleep Scale: A Manual for Use and Scoring, Version 1.0. Los Angeles, CA.
BACKGROUNDKurman RJ, Ellenson L H, and Ronnett B.M., ed. Blaustein's Pathology of the Female Genital Tract. 6th ed. New York, NY: Springer; 2011:305-452.
BACKGROUNDRevicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008 Feb;61(2):102-9. doi: 10.1016/j.jclinepi.2007.03.012. Epub 2007 Aug 3.
PMID: 18177782BACKGROUNDHays RD and Stewart AL. Sleep measures. In AL Stewart & JE Ware (eds), Measuring functioning and well-being: The Medical Outcomes Study approach (pp 235-259). Durham, NC: Duke University Press, 1992.
BACKGROUNDMcClung MR, Kagan R, Graham S, Bernick B, Mirkin S, Constantine G. Effects of E2/P4 oral capsules on bone turnover in women with vasomotor symptoms. Menopause. 2022 Feb 14;29(3):304-308. doi: 10.1097/GME.0000000000001915.
PMID: 35213517DERIVEDConstantine GD, Simon JA, Kaunitz AM, Pickar JH, Revicki DA, Graham S, Bernick B, Mirkin S. TX-001HR is associated with a clinically meaningful effect on severity of moderate to severe vasomotor symptoms in the REPLENISH trial. Menopause. 2020 Nov;27(11):1236-1241. doi: 10.1097/GME.0000000000001602.
PMID: 33110039DERIVEDBlack DR, Minkin MJ, Graham S, Bernick B, Mirkin S. Effects of combined 17beta-estradiol and progesterone on weight and blood pressure in postmenopausal women of the REPLENISH trial. Menopause. 2020 Sep 14;28(1):32-39. doi: 10.1097/GME.0000000000001659.
PMID: 32932401DERIVEDKaunitz AM, Bitner D, Constantine GD, Bernick B, Graham S, Mirkin S. 17beta-estradiol/progesterone in a single, oral, softgel capsule (TX-001HR) significantly increased the number of vasomotor symptom-free days in the REPLENISH trial. Menopause. 2020 Dec;27(12):1382-1387. doi: 10.1097/GME.0000000000001615.
PMID: 32740481DERIVEDMirkin S, Goldstein SR, Archer DF, Pickar JH, Graham S, Bernick B. Endometrial safety and bleeding profile of a 17beta-estradiol/progesterone oral softgel capsule (TX-001HR). Menopause. 2020 Apr;27(4):410-417. doi: 10.1097/GME.0000000000001480.
PMID: 31913228DERIVEDLobo RA, Kaunitz AM, Santoro N, Bernick B, Graham S, Mirkin S. Metabolic and cardiovascular effects of TX-001HR in menopausal women with vasomotor symptoms. Climacteric. 2019 Dec;22(6):610-616. doi: 10.1080/13697137.2019.1640197. Epub 2019 Jul 31.
PMID: 31364889DERIVEDMirkin S, Graham S, Revicki DA, Bender RH, Bernick B, Constantine GD. Relationship between vasomotor symptom improvements and quality of life and sleep outcomes in menopausal women treated with oral, combined 17beta-estradiol/progesterone. Menopause. 2019 Jan 9;26(6):637-642. doi: 10.1097/GME.0000000000001294.
PMID: 30601452DERIVEDKagan R, Constantine G, Kaunitz AM, Bernick B, Mirkin S. Improvement in sleep outcomes with a 17beta-estradiol-progesterone oral capsule (TX-001HR) for postmenopausal women. Menopause. 2018 Dec 21;26(6):622-628. doi: 10.1097/GME.0000000000001278.
PMID: 30586005DERIVEDLobo RA, Archer DF, Kagan R, Kaunitz AM, Constantine GD, Pickar JH, Graham S, Bernick B, Mirkin S. A 17beta-Estradiol-Progesterone Oral Capsule for Vasomotor Symptoms in Postmenopausal Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):161-170. doi: 10.1097/AOG.0000000000002645.
PMID: 29889748DERIVEDMirkin S, Amadio JM, Bernick BA, Pickar JH, Archer DF. 17beta-Estradiol and natural progesterone for menopausal hormone therapy: REPLENISH phase 3 study design of a combination capsule and evidence review. Maturitas. 2015 May;81(1):28-35. doi: 10.1016/j.maturitas.2015.02.266. Epub 2015 Mar 9.
PMID: 25835751DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sebastian Mirkin, MD, Chief Medical Officer
- Organization
- TherapeuticsMD
Study Officials
- STUDY DIRECTOR
Sebastian Mirkin, MD
TherapeuticsMD
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2013
First Posted
September 16, 2013
Study Start
August 5, 2013
Primary Completion
October 28, 2016
Study Completion
October 28, 2016
Last Updated
May 6, 2019
Results First Posted
May 6, 2019
Record last verified: 2019-04