Clinical trial NCT03840993: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Related Pain
Keywords: Endometriosis
Lead sponsor: Mitsubishi Tanabe Pharma America Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)
* 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

Primary outcomes:
measure: Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe)
timeFrame: Baseline to Week 16
measure: 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)
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranging From 0 (no Pain) to 10 (Worst Pain)
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used
timeFrame: Baseline to Week 16
measure: Time to Use of Rescue Medication (Analgesic)
timeFrame: Baseline to Week 16
measure: Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
timeFrame: Baseline to Week 16
measure: Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
timeFrame: Baseline to Week 16
measure: Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From None (0) to 3 (Severe)
timeFrame: Baseline to Week 16
measure: Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
timeFrame: Baseline to Week 16
measure: Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
timeFrame: Baseline to Week 16
measure: Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
timeFrame: Baseline to Week 16
measure: Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
timeFrame: Baseline to Week 16
measure: Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
timeFrame: Baseline to Week 16
measure: Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
timeFrame: Baseline to Week 16
measure: Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
timeFrame: Baseline to Week 16
measure: Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
timeFrame: Baseline to Week 16
measure: Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)
timeFrame: Baseline to Week 16
measure: Number of Responders Using Global 7-point Scale
timeFrame: Baseline to Week 16
measure: Percentage of Responders Using Global 7-point Scale
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline to Weeks 4, 8, 12 and 16 on the Pain Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
timeFrame: From Baseline to Weeks 4, 8, 12, and 16
measure: Number of Responders Using Endometriosis Specific 7-point Scale
timeFrame: Baseline to Week 16
measure: Percentage of Responders Using Endometriosis Specific 7-point Scale
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Control and Powerlessness Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
timeFrame: From Baseline to Weeks 4, 8, 12, and 16
measure: Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Emotional Well-Being Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
timeFrame: From Baseline to Weeks 4, 8, 12, and 16
measure: Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Social Support Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
timeFrame: From Baseline to Weeks 4, 8, 12, and 16
measure: Mean Change From Baseline to Weeks 4, 8, 12, and 16 on the Self-Image Dimension of a Scale Ranging From 100 (Worst) to 0 (Best)
timeFrame: From Baseline to Weeks 4, 8, 12, and 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Sacramento
country: United States
facility: Northern California Research Corporation
state: California
city: San Diego
country: United States
facility: Ageless and Beautiful Medical Spa
state: California
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: Torrance
country: United States
facility: The Lundquist Institute at Harbor-UCLA Medical Center
state: California
city: Fort Myers
country: United States
facility: Clinical Physiology Associates - Fort Myers
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Kendall South Medical Center
state: Florida
city: Hialeah
country: United States
facility: South Florida Clinical Trials
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Loxahatchee Groves
country: United States
facility: Axcess Medical Research
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Phase I-IV
state: Florida
city: Miami
country: United States
facility: Health and Life Research Institute
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group
state: Florida
city: Miami
country: United States
facility: Future Care Solution
state: Florida
city: Miami
country: United States
facility: Advanced Medical Research Institute
state: Florida
city: Pembroke Pines
country: United States
facility: American Research Centers of Florida
state: Florida
city: Alpharetta
country: United States
facility: Agile Clinical Research Trials
state: Georgia
city: Atlanta
country: United States
facility: Medi-Sense
state: Georgia
city: Dunwoody
country: United States
facility: NuDirections Clinical Research
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America - Marietta
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Idaho Falls
country: United States
facility: Rosemark Women Care Specialists
state: Idaho
city: Meridian
country: United States
facility: Advanced Clinical Research - Idaho
state: Idaho
city: Park Ridge
country: United States
facility: The Advanced Gynecologic Surgery Institute
state: Illinois
city: Shawnee Mission
country: United States
facility: GTC Research
state: Kansas
city: Covington
country: United States
facility: Clinical Trials Management - Covington Northshore Office
state: Louisiana
city: Metairie
country: United States
facility: Southern Clinical Research Associates
state: Louisiana
city: Shreveport
country: United States
facility: Omni Fertility and Laser Institute
state: Louisiana
city: Towson
country: United States
facility: Continental Clinical Solutions
state: Maryland
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group/Women's OB-GYN
state: Michigan
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Clinic
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Research - Raleigh
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Gynecologic Associates
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Aventive Research - Colombus
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research
state: Ohio
city: Spartanburg
country: United States
facility: ClinEdge - Fusion Clinical Research of Spartanburg
state: South Carolina
city: Chattanooga
country: United States
facility: Wake Research Associates
state: Tennessee
city: Houston
country: United States
facility: Precision Research Institute - Houston
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic - Houston
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials
state: Texas
city: Draper
country: United States
facility: Physician's Research Options (PRO)
state: Utah
city: Pleasant Grove
country: United States
facility: Physician's Research Options (PRO)
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Newport News
country: United States
facility: Health Research of Hampton Roads
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Mitsubishi Tanabe Pharma America Inc.
name: Head of Medical Science
role: STUDY_DIRECTOR
References: