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

May 12, 2023 updated by: Mitsubishi Tanabe Pharma America Inc.

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of MT-2990 in Women With Endometriosis Experiencing Endometrial Related Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Precision Trials
    • California
      • Sacramento, California, United States, 95821
        • Northern California Research Corporation
      • San Diego, California, United States, 92114
        • Precision Research Institute
      • San Diego, California, United States, 92103
        • Ageless and Beautiful Medical Spa
      • Torrance, California, United States, 90502
        • The Lundquist Institute at Harbor-UCLA Medical Center
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Clinical Physiology Associates - Fort Myers
      • Hialeah, Florida, United States, 33012
        • AGA Clinical Trials
      • Hialeah, Florida, United States, 33012
        • Kendall South Medical Center
      • Hialeah, Florida, United States, 33016
        • South Florida Clinical Trials
      • Lake Worth, Florida, United States, 33461
        • Altus Research
      • Loxahatchee Groves, Florida, United States, 33470
        • Axcess Medical Research
      • Miami, Florida, United States, 33174
        • Advanced Medical Research Institute
      • Miami, Florida, United States, 33155
        • Health and Life Research Institute
      • Miami, Florida, United States, 33155
        • Ivetmar Medical Group
      • Miami, Florida, United States, 33165
        • Future Care Solution
      • Miami Springs, Florida, United States, 33166
        • South Florida Research Phase I-IV
      • Pembroke Pines, Florida, United States, 33027
        • American Research Centers of Florida
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Agile Clinical Research Trials
      • Atlanta, Georgia, United States, 30363
        • Medi-Sense
      • Dunwoody, Georgia, United States, 30338
        • NuDirections Clinical Research
      • Marietta, Georgia, United States, 30060
        • Drug Studies America - Marietta
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Clinical Research Prime
      • Idaho Falls, Idaho, United States, 83404
        • Rosemark Women Care Specialists
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research - Idaho
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • The Advanced Gynecologic Surgery Institute
    • Kansas
      • Shawnee Mission, Kansas, United States, 66218
        • Gtc Research
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Clinical Trials Management - Covington Northshore Office
      • Metairie, Louisiana, United States, 70001
        • Southern Clinical Research Associates
      • Shreveport, Louisiana, United States, 71118
        • Omni Fertility and Laser Institute
    • Maryland
      • Towson, Maryland, United States, 21204
        • Continental Clinical Solutions
    • Michigan
      • Saginaw, Michigan, United States, 48604
        • Saginaw Valley Medical Research Group/Women's OB-GYN
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials
    • New York
      • New York, New York, United States, 10016
        • Manhattan Medical Research
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Carolina Women's Research and Wellness Clinic
      • Raleigh, North Carolina, United States, 27607
        • Unified Women's Clinical Research - Raleigh
      • Rocky Mount, North Carolina, United States, 27804
        • PMG Research of Rocky Mount
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Gynecologic Associates
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43213
        • Aventive Research - Colombus
      • Middleburg Heights, Ohio, United States, 44130
        • North Star Medical Research
    • South Carolina
      • Spartanburg, South Carolina, United States, 29301
        • ClinEdge - Fusion Clinical Research of Spartanburg
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Wake Research Associates
    • Texas
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Houston, Texas, United States, 77036
        • Precision Research Institute - Houston
      • Houston, Texas, United States, 77084
        • Biopharma Informatic - Houston
      • San Antonio, Texas, United States, 78258
        • Discovery Clinical Trials
    • Utah
      • Draper, Utah, United States, 84020
        • Physician's Research Options (PRO)
      • Pleasant Grove, Utah, United States, 84062
        • Physician's Research Options (PRO)
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • AST, ALT, or total bilirubin ≥ 2.0 × upper limit of normal (ULN) above the reference range
  • Have immunosuppression due to underlying medical condition
  • QTcF or 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MT-2990
MT-2990, IV, over 16 weeks
Drug: MT-2990
IV
Placebo Comparator: Placebo
Placebo, IV, over 16 weeks
Drug: Placebo
IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from Baseline to Week 16 in nonmenstrual pelvic pain using a pain scale ranges from 0 (none) to 3 (severe)
Time Frame: Baseline to Week 16
Baseline to Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change from Baseline to Week 16 in dysmenorrhea using a pain scale ranges from 0 (none) to 3 (severe)
Time Frame: Baseline to Week 16
Baseline to Week 16
Mean change from Baseline to Week 16 in dyspareunia using a pain scale ranges from 0 (none) to 3 (severe)
Time Frame: Baseline to Week 16
Baseline to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma America Inc.

Investigators

  • Study Director: Head of Medical Science, Mitsubishi Tanabe Pharma America Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

May 13, 2021

Study Completion (Actual)

October 5, 2021

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-2990-A01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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