Endometrial Related Pain Clinical Trial
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
| Verified date | May 2023 |
| Source | Mitsubishi Tanabe Pharma America Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 76 |
| Est. completion date | October 5, 2021 |
| Est. primary completion date | May 13, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 49 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Albuquerque Clinical Trials | Albuquerque | New Mexico |
| United States | Agile Clinical Research Trials | Alpharetta | Georgia |
| United States | Medi-Sense | Atlanta | Georgia |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | Wake Research Associates | Chattanooga | Tennessee |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Aventive Research - Colombus | Columbus | Ohio |
| United States | Clinical Trials Management - Covington Northshore Office | Covington | Louisiana |
| United States | Physician's Research Options (PRO) | Draper | Utah |
| United States | NuDirections Clinical Research | Dunwoody | Georgia |
| United States | Carolina Women's Research and Wellness Clinic | Durham | North Carolina |
| United States | Clinical Physiology Associates - Fort Myers | Fort Myers | Florida |
| United States | AGA Clinical Trials | Hialeah | Florida |
| United States | Kendall South Medical Center | Hialeah | Florida |
| United States | South Florida Clinical Trials | Hialeah | Florida |
| United States | Biopharma Informatic - Houston | Houston | Texas |
| United States | Clinical Trial Network | Houston | Texas |
| United States | Precision Research Institute - Houston | Houston | Texas |
| United States | Clinical Research Prime | Idaho Falls | Idaho |
| United States | Rosemark Women Care Specialists | Idaho Falls | Idaho |
| United States | Altus Research | Lake Worth | Florida |
| United States | Axcess Medical Research | Loxahatchee Groves | Florida |
| United States | Drug Studies America - Marietta | Marietta | Georgia |
| United States | Advanced Clinical Research - Idaho | Meridian | Idaho |
| United States | Southern Clinical Research Associates | Metairie | Louisiana |
| United States | Advanced Medical Research Institute | Miami | Florida |
| United States | Future Care Solution | Miami | Florida |
| United States | Health and Life Research Institute | Miami | Florida |
| United States | Ivetmar Medical Group | Miami | Florida |
| United States | South Florida Research Phase I-IV | Miami Springs | Florida |
| United States | North Star Medical Research | Middleburg Heights | Ohio |
| United States | Manhattan Medical Research | New York | New York |
| United States | Health Research of Hampton Roads | Newport News | Virginia |
| United States | The Advanced Gynecologic Surgery Institute | Park Ridge | Illinois |
| United States | American Research Centers of Florida | Pembroke Pines | Florida |
| United States | Precision Trials | Phoenix | Arizona |
| United States | Physician's Research Options (PRO) | Pleasant Grove | Utah |
| United States | Unified Women's Clinical Research - Raleigh | Raleigh | North Carolina |
| United States | PMG Research of Rocky Mount | Rocky Mount | North Carolina |
| United States | Northern California Research Corporation | Sacramento | California |
| United States | Saginaw Valley Medical Research Group/Women's OB-GYN | Saginaw | Michigan |
| United States | Wasatch Clinical Research | Salt Lake City | Utah |
| United States | Discovery Clinical Trials | San Antonio | Texas |
| United States | Ageless and Beautiful Medical Spa | San Diego | California |
| United States | Precision Research Institute | San Diego | California |
| United States | GTC Research | Shawnee Mission | Kansas |
| United States | Omni Fertility and Laser Institute | Shreveport | Louisiana |
| United States | ClinEdge - Fusion Clinical Research of Spartanburg | Spartanburg | South Carolina |
| United States | The Lundquist Institute at Harbor-UCLA Medical Center | Torrance | California |
| United States | Continental Clinical Solutions | Towson | Maryland |
| United States | Lyndhurst Gynecologic Associates | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Mitsubishi Tanabe Pharma America Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Mean change from Baseline to Week 16 in dysmenorrhea using a pain scale ranges from 0 (none) to 3 (severe) | Baseline to Week 16 | ||
| Secondary | Mean change from Baseline to Week 16 in dyspareunia using a pain scale ranges from 0 (none) to 3 (severe) | Baseline to Week 16 |