Endometrial Related Pain
Conditions
Keywords
Endometriosis
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.
Interventions
DRUGMT-2990
over 16 weeks
DRUGPlacebo
over 16 weeks
Sponsors
Tanabe Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 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 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 |
| 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 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 |
| 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 |
| 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 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 Responders Using Endometriosis Specific 7-point Scale | 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 |
| 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 |
| 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 |
| 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 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 |
| 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 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 |
| 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 |
| 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 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo, over 16 weeks | 39 |
| MT-2990 MT-2990, over 16 weeks | 37 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | Neutrophil count decrease, COVID-19 | 3 | 2 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Placebo | MT-2990 | Total |
|---|---|---|---|
| Age, Continuous | 34.9 years STANDARD_DEVIATION 8.3 | 32.7 years STANDARD_DEVIATION 7.6 | 33.8 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 15 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 22 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 39 Participants | 37 Participants | 76 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 37 |
| other Total, other adverse events | 22 / 39 | 23 / 37 |
| serious Total, serious adverse events | 0 / 39 | 1 / 37 |
Outcome results
Primary
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
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe) | -0.28 units on a scale | Standard Error 0.12 |
| MT-2990 | Mean Change From Baseline to Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale Ranges From 0 (None) to 3 (Severe) | -0.63 units on a scale | Standard Error 0.12 |
Secondary
Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used | -0.33 pills | Standard Error 0.09 |
| MT-2990 | Mean Change From Baseline Through Week 16 in the Number of Any Analgesic Pills Used | -0.27 pills | Standard Error 0.09 |
Secondary
Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used | -0.01 Pills | Standard Error 0.02 |
| MT-2990 | Mean Change From Baseline Through Week 16 in the Number of Opioid Pills Used | -0.04 Pills | Standard Error 0.02 |
Secondary
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
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe) | -0.47 units on a scale | Standard Error 0.15 |
| MT-2990 | Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (None) to 3 (Severe) | -0.68 units on a scale | Standard Error 0.16 |
Secondary
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
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain) | -1.33 units on a scale | Standard Error 0.48 |
| MT-2990 | Mean Change From Baseline to Week 16 in Dysmenorrhea Using a Pain Scale Ranges From 0 (no Pain) to 10 (Worst Pain) | -2.28 units on a scale | Standard Error 0.5 |
Secondary
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
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe) | -0.38 units on a scale | Standard Error 0.19 |
| MT-2990 | Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranges From 0 (None) to 3 (Severe) | -0.57 units on a scale | Standard Error 0.18 |
Secondary
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
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranging From 0 (no Pain) to 10 (Worst Pain) | -1.32 units on a scale | Standard Error 0.56 |
| MT-2990 | Mean Change From Baseline to Week 16 in Dyspareunia Using a Pain Scale Ranging From 0 (no Pain) to 10 (Worst Pain) | -2.74 units on a scale | Standard Error 0.52 |
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)
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 units on a scale | Standard Error 0.37 |
| MT-2990 | 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) | -2.33 units on a scale | Standard Error 0.39 |
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)
Time frame: From Baseline to Weeks 4, 8, 12, and 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | Change from Baseline at Week 4 | -19.80 units on a scale | Standard Error 3.68 |
| Placebo | 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) | Change from Baseline at Week 8 | -25.47 units on a scale | Standard Error 4.42 |
| Placebo | 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) | Change from Baseline at Week 12 | -26.66 units on a scale | Standard Error 5.24 |
| Placebo | 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) | Change from Baseline at Week 16 | -25.27 units on a scale | Standard Error 5.02 |
| MT-2990 | 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) | Change from Baseline at Week 16 | -35.80 units on a scale | Standard Error 5.23 |
| MT-2990 | 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) | Change from Baseline at Week 4 | -24.39 units on a scale | Standard Error 4.03 |
| MT-2990 | 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) | Change from Baseline at Week 12 | -38.03 units on a scale | Standard Error 5.42 |
| MT-2990 | 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) | Change from Baseline at Week 8 | -33.78 units on a scale | Standard Error 4.67 |
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)
Time frame: From Baseline to Weeks 4, 8, 12, and 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | Change from Baseline at Week 8 | -16.54 units on a scale | Standard Error 3.26 |
| Placebo | 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) | Change from Baseline at Week 4 | -13.31 units on a scale | Standard Error 3.03 |
| Placebo | 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) | Change from Baseline at Week 12 | -15.50 units on a scale | Standard Error 3.54 |
| Placebo | 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) | Change from Baseline at Week 16 | -18.17 units on a scale | Standard Error 3.37 |
| MT-2990 | 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) | Change from Baseline at Week 16 | -23.75 units on a scale | Standard Error 3.47 |
| MT-2990 | 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) | Change from Baseline at Week 8 | -19.01 units on a scale | Standard Error 3.42 |
| MT-2990 | 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) | Change from Baseline at Week 12 | -23.52 units on a scale | Standard Error 3.57 |
| MT-2990 | 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) | Change from Baseline at Week 4 | -13.06 units on a scale | Standard Error 3.25 |
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)
Time frame: From Baseline to Weeks 4, 8, 12, and 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | Change from Baseline at Week 4 | -15.58 units on a scale | Standard Error 3.27 |
| Placebo | 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) | Change from Baseline at Week 8 | -19.48 units on a scale | Standard Error 3.56 |
| Placebo | 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) | Change from Baseline at Week 12 | -20.03 units on a scale | Standard Error 3.89 |
| Placebo | 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) | Change from Baseline at Week 16 | -22.55 units on a scale | Standard Error 3.66 |
| MT-2990 | 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) | Change from Baseline at Week 16 | -33.55 units on a scale | Standard Error 3.78 |
| MT-2990 | 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) | Change from Baseline at Week 4 | -19.32 units on a scale | Standard Error 3.51 |
| MT-2990 | 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) | Change from Baseline at Week 12 | -34.12 units on a scale | Standard Error 3.99 |
| MT-2990 | 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) | Change from Baseline at Week 8 | -28.60 units on a scale | Standard Error 3.76 |
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)
Time frame: From Baseline to Weeks 4, 8, 12, and 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | Change from Baseline at Week 4 | -17.39 units on a scale | Standard Error 3.9 |
| Placebo | 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) | Change from Baseline at Week 12 | -17.65 units on a scale | Standard Error 4.59 |
| Placebo | 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) | Change from Baseline at Week 8 | -23.20 units on a scale | Standard Error 4.02 |
| Placebo | 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) | Change from Baseline at Week 16 | -19.42 units on a scale | Standard Error 4.53 |
| MT-2990 | 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) | Change from Baseline at Week 8 | -21.01 units on a scale | Standard Error 4.23 |
| MT-2990 | 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) | Change from Baseline at Week 4 | -14.65 units on a scale | Standard Error 4.2 |
| MT-2990 | 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) | Change from Baseline at Week 16 | -27.55 units on a scale | Standard Error 4.65 |
| MT-2990 | 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) | Change from Baseline at Week 12 | -26.45 units on a scale | Standard Error 4.54 |
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)
Time frame: From Baseline to Weeks 4, 8, 12, and 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | Change from Baseline at Week 4 | -13.77 units on a scale | Standard Error 3.66 |
| Placebo | 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) | Change from Baseline at Week 8 | -22.28 units on a scale | Standard Error 4 |
| Placebo | 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) | Change from Baseline at Week 12 | -21.35 units on a scale | Standard Error 4.74 |
| Placebo | 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) | Change from Baseline at Week 16 | -19.28 units on a scale | Standard Error 4.5 |
| MT-2990 | 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) | Change from Baseline at Week 16 | -24.52 units on a scale | Standard Error 4.66 |
| MT-2990 | 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) | Change from Baseline at Week 4 | -12.21 units on a scale | Standard Error 3.94 |
| MT-2990 | 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) | Change from Baseline at Week 12 | -23.45 units on a scale | Standard Error 4.83 |
| MT-2990 | 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) | Change from Baseline at Week 8 | -17.85 units on a scale | Standard Error 4.21 |
Secondary
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
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | -21.92 Mean percentage change | Standard Error 7.54 |
| MT-2990 | Mean Percentage Change From Baseline Through Week 16 in Dysmenorrhea Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | -30.95 Mean percentage change | Standard Error 7.76 |
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)
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 Mean percentage change | Standard Error 7.12 |
| MT-2990 | 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) | -31.37 Mean percentage change | Standard Error 7.48 |
Secondary
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
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | -26.95 Mean percentage change | Standard Error 13.18 |
| MT-2990 | Mean Percentage Change From Baseline Through Week 16 in Dyspareunia Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | -20.88 Mean percentage change | Standard Error 12.48 |
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)
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 Mean percentage change | Standard Error 10.18 |
| MT-2990 | 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) | -40.8 Mean percentage change | Standard Error 9.4 |
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)
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 mean percentage change | Standard Error 7.48 |
| MT-2990 | Mean Percentage Change From Baseline Through Week 16 in Nonmenstrual Pelvic Pain Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | -37.29 mean percentage change | Standard Error 7.86 |
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)
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 Mean percentage change | Standard Error 6.72 |
| MT-2990 | 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) | -43.07 Mean percentage change | Standard Error 7.05 |
Secondary
Number of Responders Using Endometriosis Specific 7-point Scale
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Responders Using Endometriosis Specific 7-point Scale | 14 Participants |
| MT-2990 | Number of Responders Using Endometriosis Specific 7-point Scale | 19 Participants |
Secondary
Number of Responders Using Global 7-point Scale
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Responders Using Global 7-point Scale | 12 Participants |
| MT-2990 | Number of Responders Using Global 7-point Scale | 18 Participants |
Secondary
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
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | 34.4 percentage of dysmenorrhea responders |
| MT-2990 | Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | 37.9 percentage of dysmenorrhea responders |
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)
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 percentage of dysmenorrhea responders |
| MT-2990 | Percentage of Dysmenorrhea Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | 51.7 percentage of dysmenorrhea responders |
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)
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 percentage of dyspareunia responders |
| MT-2990 | Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | 47.6 percentage of dyspareunia responders |
Secondary
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
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From None (0) to 3 (Severe) | 36.4 percentage of dyspareunia responders |
| MT-2990 | Percentage of Dyspareunia Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From None (0) to 3 (Severe) | 37.5 percentage of dyspareunia responders |
Secondary
Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe)
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | 34.4 percentage of NMPP responders |
| MT-2990 | Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (None) to 3 (Severe) | 55.2 percentage of NMPP responders |
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)
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 percentage of NMPP responders |
| MT-2990 | Percentage of NMPP Responders From Baseline Through Week 16 Using a Pain Scale That Ranges From 0 (no Pain) to 10 (Worst Pain Ever) | 48.3 percentage of NMPP responders |
Secondary
Percentage of Responders Using Endometriosis Specific 7-point Scale
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders Using Endometriosis Specific 7-point Scale | 46.7 percentage of responders |
| MT-2990 | Percentage of Responders Using Endometriosis Specific 7-point Scale | 61.3 percentage of responders |
Secondary
Percentage of Responders Using Global 7-point Scale
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Responders Using Global 7-point Scale | 40.0 Percentage of responders |
| MT-2990 | Percentage of Responders Using Global 7-point Scale | 58.1 Percentage of responders |
Secondary
Time to Use of Rescue Medication (Analgesic)
Time frame: Baseline to Week 16
Population: Overall Number of Participants Analyzed is all participants with data available in Intent To Treat (ITT) population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Use of Rescue Medication (Analgesic) | 42.0 days |
| MT-2990 | Time to Use of Rescue Medication (Analgesic) | 19.0 days |