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

Primary Purpose

Endometrial Related Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MT-2990
Placebo
Sponsored by
Mitsubishi Tanabe Pharma America Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Related Pain focused on measuring Endometriosis

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Precision Trials
  • Northern California Research Corporation
  • Ageless and Beautiful Medical Spa
  • Precision Research Institute
  • The Lundquist Institute at Harbor-UCLA Medical Center
  • Clinical Physiology Associates - Fort Myers
  • AGA Clinical Trials
  • Kendall South Medical Center
  • South Florida Clinical Trials
  • Altus Research
  • Axcess Medical Research
  • South Florida Research Phase I-IV
  • Health and Life Research Institute
  • Ivetmar Medical Group
  • Future Care Solution
  • Advanced Medical Research Institute
  • American Research Centers of Florida
  • Agile Clinical Research Trials
  • Medi-Sense
  • NuDirections Clinical Research
  • Drug Studies America - Marietta
  • Clinical Research Prime
  • Rosemark Women Care Specialists
  • Advanced Clinical Research - Idaho
  • The Advanced Gynecologic Surgery Institute
  • GTC Research
  • Clinical Trials Management - Covington Northshore Office
  • Southern Clinical Research Associates
  • Omni Fertility and Laser Institute
  • Continental Clinical Solutions
  • Saginaw Valley Medical Research Group/Women's OB-GYN
  • Albuquerque Clinical Trials
  • Manhattan Medical Research
  • Carolina Women's Research and Wellness Clinic
  • Unified Women's Clinical Research - Raleigh
  • PMG Research of Rocky Mount
  • Lyndhurst Gynecologic Associates
  • University Hospitals Cleveland Medical Center
  • Aventive Research - Colombus
  • North Star Medical Research
  • ClinEdge - Fusion Clinical Research of Spartanburg
  • Wake Research Associates
  • Precision Research Institute - Houston
  • Clinical Trial Network
  • Biopharma Informatic - Houston
  • Discovery Clinical Trials
  • Physician's Research Options (PRO)
  • Physician's Research Options (PRO)
  • Wasatch Clinical Research
  • Health Research of Hampton Roads
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MT-2990

Placebo

Arm Description

MT-2990, IV, over 16 weeks

Placebo, IV, over 16 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 4, 2019
Last Updated
May 12, 2023
Sponsor
Mitsubishi Tanabe Pharma America Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03840993
Brief Title
Safety and Efficacy Study of MT-2990 in Women With Endometriosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
May 13, 2021 (Actual)
Study Completion Date
October 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma America Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Related Pain
Keywords
Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-2990
Arm Type
Experimental
Arm Description
MT-2990, IV, over 16 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, IV, over 16 weeks
Intervention Type
Drug
Intervention Name(s)
MT-2990
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Head of Medical Science
Organizational Affiliation
Mitsubishi Tanabe Pharma America Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Precision Trials
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Northern California Research Corporation
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Ageless and Beautiful Medical Spa
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Precision Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
The Lundquist Institute at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Clinical Physiology Associates - Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
AGA Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Kendall South Medical Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
South Florida Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Axcess Medical Research
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
South Florida Research Phase I-IV
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Health and Life Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Ivetmar Medical Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Future Care Solution
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Advanced Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
American Research Centers of Florida
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Agile Clinical Research Trials
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Medi-Sense
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30363
Country
United States
Facility Name
NuDirections Clinical Research
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Drug Studies America - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Rosemark Women Care Specialists
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Advanced Clinical Research - Idaho
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
The Advanced Gynecologic Surgery Institute
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
GTC Research
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Clinical Trials Management - Covington Northshore Office
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Southern Clinical Research Associates
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Omni Fertility and Laser Institute
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71118
Country
United States
Facility Name
Continental Clinical Solutions
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Saginaw Valley Medical Research Group/Women's OB-GYN
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Manhattan Medical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Carolina Women's Research and Wellness Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Unified Women's Clinical Research - Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
PMG Research of Rocky Mount
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Lyndhurst Gynecologic Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Aventive Research - Colombus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
North Star Medical Research
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
ClinEdge - Fusion Clinical Research of Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29301
Country
United States
Facility Name
Wake Research Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Precision Research Institute - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Biopharma Informatic - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Discovery Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Physician's Research Options (PRO)
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Physician's Research Options (PRO)
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Health Research of Hampton Roads
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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