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

Completed · Phase 2 · Has a placebo group

Conditions studied: Endometrial Related Pain

In brief

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.

Key facts

Study ID

NCT03840993

Run by

Tanabe Pharma America, Inc.

People needed

76

Starts

2019-01-15

Expected to finish

2021-10-05

Last updated by the study team

2025-12-31

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northern California Research Corporation — Sacramento, California, United States
• Ageless and Beautiful Medical Spa — San Diego, California, United States
• Precision Research Institute — San Diego, California, United States
• The Lundquist Institute at Harbor-UCLA Medical Center — Torrance, California, 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
• Altus Research — Lake Worth, Florida, United States
• Axcess Medical Research — Loxahatchee Groves, Florida, United States
• Health and Life Research Institute — Miami, Florida, United States
• Ivetmar Medical Group — Miami, Florida, United States
• Future Care Solution — Miami, Florida, United States
• Advanced Medical Research Institute — Miami, Florida, United States
• South Florida Research Phase I-IV — Miami Springs, Florida, United States
• American Research Centers of Florida — Pembroke Pines, Florida, United States
• Agile Clinical Research Trials — Alpharetta, Georgia, United States
• Medi-Sense — Atlanta, Georgia, United States
• NuDirections Clinical Research — Dunwoody, Georgia, United States
• Drug Studies America - Marietta — Marietta, Georgia, United States
• Clinical Research Prime — Idaho Falls, Idaho, United States
• Rosemark Women Care Specialists — Idaho Falls, Idaho, United States
• Advanced Clinical Research - Idaho — Meridian, Idaho, United States
• The Advanced Gynecologic Surgery Institute — Park Ridge, Illinois, United States
• Precision Trials — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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