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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Endometrial Related Pain

Intervention / Treatment
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* Drug: MT-2990
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-2990<br>MT-2990, IV, over 16 weeks | Drug: MT-2990<br>* IV<br>|
| Placebo Comparator: Placebo<br>Placebo, IV, over 16 weeks | Drug: Placebo<br>* IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 change from Baseline to Week 16 in dyspareunia using a pain scale ranges from 0 (none) to 3 (severe) |  | Baseline to Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis