Phase 2 N=76 Randomized Quadruple-blind Treatment

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

Endometrial Related Pain

Bottom Line

View on ClinicalTrials.gov: NCT03840993 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Jul 2024

Primary outcome: Primary: Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe) — -0.28; -0.63 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: MT-2990 (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Tanabe Pharma America, Inc.
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe)	-0.28; -0.63	—
SECONDARY Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe)	-0.47; -0.68	—
SECONDARY Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe)	-0.38; -0.57	—
SECONDARY 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)	-1.05; -2.33	—
SECONDARY Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain)	-1.33; -2.28	—
SECONDARY Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranging From 0 (no Pain) to 10 (Worst Pain)	-1.32; -2.74	—
SECONDARY Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used	-0.33; -0.27	—
SECONDARY Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used	-0.01; -0.04	—
SECONDARY Time to Use of Rescue Medication (Analgesic)	42.0; 19.0	—
SECONDARY Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)	34.4; 55.2	—
SECONDARY Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)	34.4; 37.9	—
SECONDARY Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From None (0) to 3 (Severe)	36.4; 37.5	—
SECONDARY Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)	-18.87; -37.29	—
SECONDARY Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)	-21.92; -30.95	—
SECONDARY Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)	-26.95; -20.88	—
SECONDARY Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)	25.0; 48.3	—
SECONDARY Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)	34.4; 51.7	—
SECONDARY Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever)	31.6; 47.6	—
SECONDARY 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)	-21.2; -43.07	—
SECONDARY 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)	-18.54; -31.37	—
SECONDARY 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)	-29.04; -40.8	—
SECONDARY Number of Responders Using Global 7-point Scale	12; 18	—
SECONDARY Percentage of Responders Using Global 7-point Scale	40.0; 58.1	—
SECONDARY 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)	-15.58; -19.32; -19.48; -28.60; -20.03; -34.12	—
SECONDARY Number of Responders Using Endometriosis Specific 7-point Scale	14; 19	—
SECONDARY Percentage of Responders Using Endometriosis Specific 7-point Scale	46.7; 61.3	—
SECONDARY 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)	-19.80; -24.39; -25.47; -33.78; -26.66; -38.03	—
SECONDARY 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)	-13.31; -13.06; -16.54; -19.01; -15.50; -23.52	—
SECONDARY 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)	-13.77; -12.21; -22.28; -17.85; -21.35; -23.45	—
SECONDARY 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)	-17.39; -14.65; -23.20; -21.01; -17.65; -26.45	—

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.

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03840993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.