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

Phase 2

Completed

Conditions: Endometrial Related Pain

Interventions: Drug: Placebo
Drug: MT-2990

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

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

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
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
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
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): Precision Trials
🇺🇸
Phoenix, Arizona, United States
Northern California Research Corporation
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Sacramento, California, United States
Ageless and Beautiful Medical Spa
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San Diego, California, United States
Precision Research Institute
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San Diego, California, United States
The Lundquist Institute at Harbor-UCLA Medical Center
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Torrance, California, United States
Clinical Physiology Associates - Fort Myers
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Fort Myers, Florida, United States
AGA Clinical Trials
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Hialeah, Florida, United States
Kendall South Medical Center
🇺🇸
Hialeah, Florida, United States
South Florida Clinical Trials
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Hialeah, Florida, United States
Altus Research
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Lake Worth, Florida, United States
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Precision Trials
🇺🇸Phoenix, Arizona, United States