Safety and Efficacy Study of MT-2990 in Women With Endometriosis
NCT ID: NCT03840993
Last Updated: 2025-12-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2019-01-15
2021-10-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MT-2990
MT-2990, over 16 weeks
MT-2990
over 16 weeks
Placebo
Placebo, over 16 weeks
Placebo
over 16 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MT-2990
over 16 weeks
Placebo
over 16 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Agree to approximately 30-90 day washout interval of hormonal therapies, if applicable
* Have a history of regular menstrual cycles
* Have a body mass index \< 45 kg/m\^2 (inclusive)
* Have documented surgical/laparoscopy diagnosis of endometriosis with 10 years
* Agree to use 2 forms of nonhormonal contraception throughout the study
* In the Investigator's opinion, subject is able to understand the nature of the study and any risk involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements including transvaginal ultrasound.
* Have moderate to severe endometrial related pain
Exclusion Criteria
* Subject is \< 6 months postpartum, postabortion, or post-pregnancy.
* Willing to remove a hormonal intrauterine device (IUD) at least 30 days prior to screening. (Non hormonal IUDs do not have to be removed)
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) , or total bilirubin ≥ 2.0 × upper limit of normal (ULN) above the reference range
* Have immunosuppression due to underlying medical condition
* Corrected QT interval using Fridericia's formula (QTcF) or Corrected QT interval using Bazett's formula (QTcB) ≥ 450 msec or clinically important abnormal findings on the ECG
* Subject is not up-to-date on breast screening according to current guidelines.
* Has a surgical history of hysterectomy, bilateral oophorectomy and any other recent major surgery
* Subject is required more than 2 weeks of continuous use of prohibited long-acting narcotic or immediate release narcotic for treatment of endometriosis-associated pain.
* Have chronic pelvic pain for nonendometriosis related causes, which require systemic pharmaceutical chronic therapy for pain
* Have other chronic pain syndrome which require chronic analgesic or other chronic therapy
* Have a clinically significant gynecologic condition identified on the transvaginal ultrasound (TVU) (e.g., complex ovarian cyst \> 3 cm or simple ovarian cyst \> 5 cm, clinically significant endometrial pathology, single fibroid ≥ 4 cm or multiple (\> 4) fibroids that measure ≥ 2 cm or symptomatic submucosal fibroid of any size
* Have a current history of undiagnosed abnormal genital bleeding
18 Years
49 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tanabe Pharma America, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Head of Medical Science
Role: STUDY_DIRECTOR
Tanabe Pharma America, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Precision Trials
Phoenix, Arizona, United States
Northern California Research Corporation
Sacramento, California, United States
Ageless and Beautiful Medical Spa
San Diego, California, United States
Precision Research Institute
San Diego, California, United States
The Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California, United States
Clinical Physiology Associates - Fort Myers
Fort Myers, Florida, United States
AGA Clinical Trials
Hialeah, Florida, United States
Kendall South Medical Center
Hialeah, Florida, United States
South Florida Clinical Trials
Hialeah, Florida, United States
Altus Research
Lake Worth, Florida, United States
Axcess Medical Research
Loxahatchee Groves, Florida, United States
Health and Life Research Institute
Miami, Florida, United States
Ivetmar Medical Group
Miami, Florida, United States
Future Care Solution
Miami, Florida, United States
Advanced Medical Research Institute
Miami, Florida, United States
South Florida Research Phase I-IV
Miami Springs, Florida, United States
American Research Centers of Florida
Pembroke Pines, Florida, United States
Agile Clinical Research Trials
Alpharetta, Georgia, United States
Medi-Sense
Atlanta, Georgia, United States
NuDirections Clinical Research
Dunwoody, Georgia, United States
Drug Studies America - Marietta
Marietta, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States
Advanced Clinical Research - Idaho
Meridian, Idaho, United States
The Advanced Gynecologic Surgery Institute
Park Ridge, Illinois, United States
GTC Research
Shawnee Mission, Kansas, United States
Clinical Trials Management - Covington Northshore Office
Covington, Louisiana, United States
Southern Clinical Research Associates
Metairie, Louisiana, United States
Omni Fertility and Laser Institute
Shreveport, Louisiana, United States
Continental Clinical Solutions
Towson, Maryland, United States
Saginaw Valley Medical Research Group/Women's OB-GYN
Saginaw, Michigan, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Manhattan Medical Research
New York, New York, United States
Carolina Women's Research and Wellness Clinic
Durham, North Carolina, United States
Unified Women's Clinical Research - Raleigh
Raleigh, North Carolina, United States
PMG Research of Rocky Mount
Rocky Mount, North Carolina, United States
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Aventive Research - Colombus
Columbus, Ohio, United States
North Star Medical Research
Middleburg Heights, Ohio, United States
ClinEdge - Fusion Clinical Research of Spartanburg
Spartanburg, South Carolina, United States
Wake Research Associates
Chattanooga, Tennessee, United States
Precision Research Institute - Houston
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Biopharma Informatic - Houston
Houston, Texas, United States
Discovery Clinical Trials
San Antonio, Texas, United States
Physician's Research Options (PRO)
Draper, Utah, United States
Physician's Research Options (PRO)
Pleasant Grove, Utah, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Health Research of Hampton Roads
Newport News, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MT-2990-A01
Identifier Type: -
Identifier Source: org_study_id