Safety and Efficacy Study of MT-2990 in Women With Endometriosis

NCT03840993 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MT-2990-A01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 51

Brief Summary

The purpose of this study is to assess the safety and efficacy of MT-2990 for treatment of moderate to severe endometriosis-related pain in women with surgically diagnosed endometriosis.

Conditions

Endometrial Related Pain

Keywords

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe)

  Baseline to Week 16

Secondary Outcomes (29)

• Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe)

  Baseline to Week 16

• Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe)

  Baseline to Week 16

• Mean Change From Baseline to Week 16 in Non-Menstrual Pelvic Pain (NMPP) Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)

  Baseline to Week 16

• Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)

  Baseline to Week 16

• Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranging From 0 (no Pain) to 10 (Worst Pain)

  Baseline to Week 16

Study Arms (2)

MT-2990

EXPERIMENTAL

MT-2990, over 16 weeks

Drug: MT-2990

Placebo

PLACEBO COMPARATOR

Placebo, over 16 weeks

Drug: Placebo

Interventions

MT-2990 DRUG

over 16 weeks

MT-2990

Placebo DRUG

over 16 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provide written informed consent to participate in this study
• 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

You may not qualify if:

• Subject is pregnant, breast feeding, or planning a pregnancy.
• 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

Sponsors & Collaborators

• Tanabe Pharma America, Inc.: lead

Study Sites (51)

Precision Trials

Phoenix, Arizona, 85032, United States

Location

Northern California Research Corporation

Sacramento, California, 95821, United States

Location

Ageless and Beautiful Medical Spa

San Diego, California, 92103, United States

Location

Precision Research Institute

San Diego, California, 92114, United States

Location

The Lundquist Institute at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Clinical Physiology Associates - Fort Myers

Fort Myers, Florida, 33912, United States

Location

AGA Clinical Trials

Hialeah, Florida, 33012, United States

Location

Kendall South Medical Center

Hialeah, Florida, 33012, United States

Location

South Florida Clinical Trials

Hialeah, Florida, 33016, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Axcess Medical Research

Loxahatchee Groves, Florida, 33470, United States

Location

Health and Life Research Institute

Miami, Florida, 33155, United States

Location

Ivetmar Medical Group

Miami, Florida, 33155, United States

Location

Future Care Solution

Miami, Florida, 33165, United States

Location

Advanced Medical Research Institute

Miami, Florida, 33174, United States

Location

South Florida Research Phase I-IV

Miami Springs, Florida, 33166, United States

Location

American Research Centers of Florida

Pembroke Pines, Florida, 33027, United States

Location

Agile Clinical Research Trials

Alpharetta, Georgia, 30005, United States

Location

Medi-Sense

Atlanta, Georgia, 30363, United States

Location

NuDirections Clinical Research

Dunwoody, Georgia, 30338, United States

Location

Drug Studies America - Marietta

Marietta, Georgia, 30060, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Rosemark Women Care Specialists

Idaho Falls, Idaho, 83404, United States

Location

Advanced Clinical Research - Idaho

Meridian, Idaho, 83642, United States

Location

The Advanced Gynecologic Surgery Institute

Park Ridge, Illinois, 60068, United States

Location

GTC Research

Shawnee Mission, Kansas, 66218, United States

Location

Clinical Trials Management - Covington Northshore Office

Covington, Louisiana, 70433, United States

Location

Southern Clinical Research Associates

Metairie, Louisiana, 70001, United States

Location

Omni Fertility and Laser Institute

Shreveport, Louisiana, 71118, United States

Location

Continental Clinical Solutions

Towson, Maryland, 21204, United States

Location

Saginaw Valley Medical Research Group/Women's OB-GYN

Saginaw, Michigan, 48604, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

Carolina Women's Research and Wellness Clinic

Durham, North Carolina, 27713, United States

Location

Unified Women's Clinical Research - Raleigh

Raleigh, North Carolina, 27607, United States

Location

PMG Research of Rocky Mount

Rocky Mount, North Carolina, 27804, United States

Location

Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, 27103, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Aventive Research - Colombus

Columbus, Ohio, 43213, United States

Location

North Star Medical Research

Middleburg Heights, Ohio, 44130, United States

Location

ClinEdge - Fusion Clinical Research of Spartanburg

Spartanburg, South Carolina, 29301, United States

Location

Wake Research Associates

Chattanooga, Tennessee, 37421, United States

Location

Precision Research Institute - Houston

Houston, Texas, 77036, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Biopharma Informatic - Houston

Houston, Texas, 77084, United States

Location

Discovery Clinical Trials

San Antonio, Texas, 78258, United States

Location

Physician's Research Options (PRO)

Draper, Utah, 84020, United States

Location

Physician's Research Options (PRO)

Pleasant Grove, Utah, 84062, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Health Research of Hampton Roads

Newport News, Virginia, 23606, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma America, Inc.

information.US@mb.tanabe-pharma.com

Please email

Study Officials

• Head of Medical Science

  Tanabe Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 15, 2019
• Study Start: January 15, 2019
• Primary Completion: May 13, 2021
• Study Completion: October 5, 2021
• Last Updated: December 31, 2025
• Results First Posted: July 10, 2024

Record last verified: 2025-12

Locations

US (51)