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

Tanabe Pharma America, Inc.76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Endometrial Related Pain

Interventions

MT-2990DRUG

over 16 weeks

PlaceboDRUG

over 16 weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

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

Locations (51)

Outcomes

Primary Outcomes

Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe)

Time frame: Baseline to Week 16

Secondary Outcomes

Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe)

Time frame: Baseline to Week 16

Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Baseline to Week 16

Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used

Time frame: Baseline to Week 16

Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used

Time frame: Baseline to Week 16

Time to Use of Rescue Medication (Analgesic)

Time frame: 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)

Data from ClinicalTrials.gov

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Time frame: 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)

Time frame: Baseline to Week 16

Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From None (0) to 3 (Severe)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Baseline to Week 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Baseline to Week 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)

Time frame: Baseline to Week 16

Number of Responders Using Global 7-point Scale

Time frame: Baseline to Week 16

Percentage of Responders Using Global 7-point Scale

Time frame: 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)

Time frame: From Baseline to Weeks 4, 8, 12, and 16

Number of Responders Using Endometriosis Specific 7-point Scale

Time frame: Baseline to Week 16

Percentage of Responders Using Endometriosis Specific 7-point Scale

Time frame: 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)

Time frame: From Baseline to Weeks 4, 8, 12, and 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)

Time frame: 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)

Time frame: 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)

Time frame: From Baseline to Weeks 4, 8, 12, and 16