Safety and Efficacy Study of MT-2990 in Women With Endometriosis
- Registration Number
- NCT03840993
- Lead Sponsor
- Mitsubishi Tanabe Pharma America Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 76
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo, over 16 weeks MT-2990 MT-2990 MT-2990, over 16 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From None (0) to 3 (Severe) Baseline to Week 16 Time to Use of Rescue Medication (Analgesic) Baseline to Week 16 Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) Baseline to Week 16 Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) Baseline to Week 16 Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That 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 Ranges From 0 (None) to 3 (Severe) 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 Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used Baseline to Week 16 Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used Baseline to Week 16 Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) Baseline to Week 16 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) Baseline to Week 16 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 Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) Baseline to Week 16 Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) Baseline to Week 16 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) Baseline to Week 16 Number of Responders Using Endometriosis Specific 7-point Scale Baseline to Week 16 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) From Baseline to Weeks 4, 8, 12, and 16 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) From Baseline to Weeks 4, 8, 12, and 16 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) From Baseline to Weeks 4, 8, 12, and 16 Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) Baseline to Week 16 Number of Responders Using Global 7-point Scale Baseline to Week 16 Percentage of Responders Using Global 7-point Scale Baseline to Week 16 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) From Baseline to Weeks 4, 8, 12, and 16 Percentage of Responders Using Endometriosis Specific 7-point Scale Baseline to Week 16 Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) Baseline to Week 16 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) From Baseline to Weeks 4, 8, 12, and 16 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) Baseline to Week 16
Trial Locations
- Locations (50)
Medi-Sense
🇺🇸Atlanta, Georgia, United States
Drug Studies America - Marietta
🇺🇸Marietta, Georgia, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Precision Research Institute - Houston
🇺🇸Houston, Texas, United States
Future Care Solution
🇺🇸Miami, Florida, United States
Advanced Medical Research Institute
🇺🇸Miami, Florida, United States
Health and Life Research Institute
🇺🇸Miami, Florida, United States
American Research Centers of Florida
🇺🇸Pembroke Pines, Florida, United States
The Advanced Gynecologic Surgery Institute
🇺🇸Park Ridge, Illinois, United States
Axcess Medical Research
🇺🇸Loxahatchee Groves, Florida, United States
NuDirections Clinical Research
🇺🇸Dunwoody, Georgia, United States
South Florida Research Phase I-IV
🇺🇸Miami Springs, Florida, United States
South Florida Clinical Trials
🇺🇸Hialeah, Florida, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
Saginaw Valley Medical Research Group/Women's OB-GYN
🇺🇸Saginaw, Michigan, United States
Unified Women's Clinical Research - Raleigh
🇺🇸Raleigh, North Carolina, United States
Agile Clinical Research Trials
🇺🇸Alpharetta, Georgia, United States
Ivetmar Medical Group
🇺🇸Miami, Florida, United States
Manhattan Medical Research
🇺🇸New York, New York, United States
The Lundquist Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Omni Fertility and Laser Institute
🇺🇸Shreveport, Louisiana, United States
Health Research of Hampton Roads
🇺🇸Newport News, Virginia, United States
Continental Clinical Solutions
🇺🇸Towson, Maryland, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
North Star Medical Research
🇺🇸Middleburg Heights, Ohio, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
ClinEdge - Fusion Clinical Research of Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Ageless and Beautiful Medical Spa
🇺🇸San Diego, California, United States
Discovery Clinical Trials
🇺🇸San Antonio, Texas, United States
Carolina Women's Research and Wellness Clinic
🇺🇸Durham, North Carolina, United States
Aventive Research - Colombus
🇺🇸Columbus, Ohio, United States
Biopharma Informatic - Houston
🇺🇸Houston, Texas, United States
PMG Research of Rocky Mount
🇺🇸Rocky Mount, North Carolina, United States
Clinical Physiology Associates - Fort Myers
🇺🇸Fort Myers, Florida, United States
Precision Trials
🇺🇸Phoenix, Arizona, United States
Kendall South Medical Center
🇺🇸Hialeah, Florida, United States
Precision Research Institute
🇺🇸San Diego, California, United States
AGA Clinical Trials
🇺🇸Hialeah, Florida, United States
Advanced Clinical Research - Idaho
🇺🇸Meridian, Idaho, United States
Rosemark Women Care Specialists
🇺🇸Idaho Falls, Idaho, United States
Clinical Trials Management - Covington Northshore Office
🇺🇸Covington, Louisiana, United States
GTC Research
🇺🇸Shawnee Mission, Kansas, United States
Physician's Research Options (PRO)
🇺🇸Pleasant Grove, Utah, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
Wake Research Associates
🇺🇸Chattanooga, Tennessee, United States
Southern Clinical Research Associates
🇺🇸Metairie, Louisiana, United States
Northern California Research Corporation
🇺🇸Sacramento, California, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Lyndhurst Gynecologic Associates
🇺🇸Winston-Salem, North Carolina, United States