Endometriosis
Conditions
Brief summary
This study is designed to evaluate the safety and efficacy of HMI-115 compared to placebo over a 12 weeks period on subjects with moderate to severe endometriosis-associated pain.
Detailed description
This study aims to evaluate the safety and efficacy of HMI-115 versus a placebo in pre-menopausal women with moderate to severe Endometriosis associated pain. The study will determine the safety and efficacy of HMI 115 at 3 dose levels.
Interventions
DRUGHMI-115
HMI-115 is human monoclonal antibody
DRUGPlacebo
Placebo
Sponsors
Hope Medicine (Nanjing) Co., Ltd
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
1. Pre-menopausal female subjects, between 18 and 49 years of age, inclusive, at the time of signing informed consent. 2. Subject must have a clinical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening. 3. Subject must have a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 with a score of at least 2 for DYS and at least 2 for NMPP at screening. 4. Subject agrees not to participate in another interventional study while participating in the present study.
Exclusion criteria
1. Subject is pregnant or breastfeeding or is planning a pregnancy during the study period. 2. Subject has chronic pelvic pain that is not caused by endometriosis or has any other chronic pain syndrome or other chronic therapy, or that would interfere with the assessment of endometriosis-related pain 3. Subject has clinically significant gynecologic condition other than endometriosis 4. Subject has previous history of a severe, life-threatening or other significant sensitivity to any opioids or non-steroidal anti inflammatory drugs (NSAIDS) or any contraindication to their use such as gastrointestinal ulcer or bleeding 5. Subject has history of hysterectomy and/or bilateral oophorectomy 6. Subjects with past or present pituitary tumor growth 7. Subjects has a history of osteoporosis or other metabolic bone disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change) | Baseline, Week 12 | The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. |
| Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12（Absolute Score Change） | Baseline, Week 12 | The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change) | Baseline, Week 24 | The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. |
| Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change) | Baseline, week 12 and 24 | The Numeric Rating Scale for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. |
| Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change) | Baseline, week 12 and 24 | The Numering Rating Score for dyspareunia ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. |
| Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Baseline, week 12 and 24 | Endometriosis Daily Impact Pain Scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The higher scores mean worse outcome. |
| Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use | Baseline, week 12 and 24 | Assessment was based on average pill counts at each apecific period od days |
| Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit | Baseline, week 12 and 24 | Assessment was based on tampons or pads used. 0 means no bleeding, 4 means heavy bleeding. Higher score means more bleeding. |
| Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change) | Baseline, Week 24 | The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. |
| Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Baseline, Week12, Week24 | The Numeric Rating Scale (NRS) for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. |
| Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Baseline, Week12, Week24 | The Numering Rating Score(NRS) for dyspareunia(DYSP) ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. |
Countries
China, Poland, United States
Participant flow
Recruitment details
The study was conducted in China, the United States of America (USA), and Poland.Total of 310 subjects were screened, of which 142 subjects were randomized. Among them, 36 subjects received HMI-115 60 mg, 36 received HMI-115 120 mg, 35 received HMI-115 240 mg, and 35 subjects were randomized to receive placebo. In the protocol version 5.0, part 2 of the study was deleted and not executed. So no subject was recruited in the former planned part 2 study.
Pre-assignment details
1\. Screening Period: up to 75 days prior to first dose * Screening Visit 1 * Screening Visit 2 (at least 35 days before Visit 3 to ensure at least 5 weeks Baseline pain score obtained before randomization)
Participants by arm
| Arm | Count |
|---|---|
| HMI-115 60mg Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody | 27 |
| HMI-115 120mg Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody | 27 |
| HMI-115 240mg Once Every 2 weeks, subcutaneously injection
HMI-115: HMI-115 is human monoclonal antibody | 24 |
| Placebo Once Every 2 weeks, subcutaneously injection
Placebo: Placebo | 30 |
| Total | 108 |
Baseline characteristics
| Characteristic | Total | Placebo | HMI-115 240mg | HMI-115 120mg | HMI-115 60mg |
|---|---|---|---|---|---|
| Age, Continuous | 38.0 years STANDARD_DEVIATION 5.05 | 38.1 years STANDARD_DEVIATION 5.17 | 37.4 years STANDARD_DEVIATION 5.31 | 36.4 years STANDARD_DEVIATION 4.99 | 39.9 years STANDARD_DEVIATION 4.43 |
| Average Menstrual Bleeding Score | 2.629 units on a scale STANDARD_DEVIATION 0.606 | 2.514 units on a scale STANDARD_DEVIATION 0.5826 | 2.722 units on a scale STANDARD_DEVIATION 0.561 | 2.710 units on a scale STANDARD_DEVIATION 0.7107 | 2.594 units on a scale STANDARD_DEVIATION 0.5639 |
| BMI | 23.57 kg/m2 STANDARD_DEVIATION 3.873 | 23.25 kg/m2 STANDARD_DEVIATION 4.223 | 24.40 kg/m2 STANDARD_DEVIATION 4.046 | 23.17 kg/m2 STANDARD_DEVIATION 3.22 | 23.57 kg/m2 STANDARD_DEVIATION 4.011 |
| DYS NRS | 6.127 units on a scale STANDARD_DEVIATION 1.7909 | 5.696 units on a scale STANDARD_DEVIATION 2.0005 | 5.910 units on a scale STANDARD_DEVIATION 1.8236 | 6.393 units on a scale STANDARD_DEVIATION 2.1123 | 6.288 units on a scale STANDARD_DEVIATION 1.4261 |
| Endometriosis duration | 66.5 months STANDARD_DEVIATION 31.7 | 73.7 months STANDARD_DEVIATION 27.2 | 67.4 months STANDARD_DEVIATION 28.7 | 57.0 months STANDARD_DEVIATION 31.8 | 67.2 months STANDARD_DEVIATION 37.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants | 29 Participants | 24 Participants | 27 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Monthly Mean Endometriosis Daily Impact Pain Scale DYS | 2.223 units on a scale STANDARD_DEVIATION 0.5626 | 2.122 units on a scale STANDARD_DEVIATION 0.6031 | 2.193 units on a scale STANDARD_DEVIATION 0.558 | 2.281 units on a scale STANDARD_DEVIATION 0.6385 | 2.303 units on a scale STANDARD_DEVIATION 0.437 |
| Monthly Mean Endometriosis Daily Impact Pain Scale DYSP | 1.149 units on a scale STANDARD_DEVIATION 0.7483 | 1.358 units on a scale STANDARD_DEVIATION 0.6214 | 1.102 units on a scale STANDARD_DEVIATION 0.8189 | 1.158 units on a scale STANDARD_DEVIATION 0.9168 | 0.906 units on a scale STANDARD_DEVIATION 0.6429 |
| Monthly Mean Endometriosis Daily Impact Pain Scale NMPP | 1.481 units on a scale STANDARD_DEVIATION 0.6102 | 1.435 units on a scale STANDARD_DEVIATION 0.6191 | 1.588 units on a scale STANDARD_DEVIATION 0.6516 | 1.529 units on a scale STANDARD_DEVIATION 0.5878 | 1.390 units on a scale STANDARD_DEVIATION 0.6 |
| NMPP NRS | 3.824 units on a scale STANDARD_DEVIATION 1.8253 | 3.643 units on a scale STANDARD_DEVIATION 1.8806 | 4.052 units on a scale STANDARD_DEVIATION 2.0056 | 3.985 units on a scale STANDARD_DEVIATION 1.6538 | 3.662 units on a scale STANDARD_DEVIATION 1.8258 |
| NSAIDs | 1.307 pills STANDARD_DEVIATION 1.3654 | 1.112 pills STANDARD_DEVIATION 1.1415 | 1.411 pills STANDARD_DEVIATION 1.4096 | 1.481 pills STANDARD_DEVIATION 1.7239 | 1.283 pills STANDARD_DEVIATION 1.2805 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 49 Participants | 15 Participants | 9 Participants | 13 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 58 Participants | 15 Participants | 14 Participants | 14 Participants | 15 Participants |
| Region of Enrollment China | 49 participants | 15 participants | 9 participants | 13 participants | 12 participants |
| Region of Enrollment Poland | 54 participants | 13 participants | 14 participants | 13 participants | 14 participants |
| Region of Enrollment United States | 5 participants | 2 participants | 1 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 108 Participants | 30 Participants | 24 Participants | 27 Participants | 27 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 | 0 / 24 | 0 / 30 |
| other Total, other adverse events | 15 / 27 | 16 / 27 | 18 / 24 | 11 / 30 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 | 1 / 24 | 0 / 30 |
Outcome results
Primary
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12（Absolute Score Change）
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, Week 12
Population: All randomized subjects with at least 1 dose with surgical diagnosis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| HMI-115 60mg | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12（Absolute Score Change） | -2.57 score on a scale | Standard Error 0.542 |
| HMI-115 120mg | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12（Absolute Score Change） | -3.29 score on a scale | Standard Error 0.546 |
| HMI-115 240mg | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12（Absolute Score Change） | -3.26 score on a scale | Standard Error 0.579 |
| Placebo | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12（Absolute Score Change） | -2.31 score on a scale | Standard Error 0.502 |
Primary
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change)
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, Week 12
Population: PAS: All randomized subjects with at least 1 dose with surgical diagnosis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| HMI-115 60mg | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change) | -27.35 percentage of change from baseline | Standard Error 9.568 |
| HMI-115 120mg | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change) | -34.72 percentage of change from baseline | Standard Error 9.63 |
| HMI-115 240mg | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change) | -41.57 percentage of change from baseline | Standard Error 10.234 |
| Placebo | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 (Percentage Change) | -18.61 percentage of change from baseline | Standard Error 8.859 |
Secondary
Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use
Assessment was based on average pill counts at each apecific period od days
Time frame: Baseline, week 12 and 24
Population: PAS: All randomized subjects with at least 1 dose with surgical diagnosis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HMI-115 60mg | Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use | CFB Week12 Average pill count Tier 1 | -0.656 pill | Standard Deviation 1.402 |
| HMI-115 60mg | Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use | CFB Week24 Average pill count Tier1 | -0.394 pill | Standard Deviation 1.4724 |
| HMI-115 120mg | Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use | CFB Week24 Average pill count Tier1 | -0.643 pill | Standard Deviation 1.8192 |
| HMI-115 120mg | Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use | CFB Week12 Average pill count Tier 1 | -0.463 pill | Standard Deviation 0.9113 |
| HMI-115 240mg | Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use | CFB Week12 Average pill count Tier 1 | -1.001 pill | Standard Deviation 1.49 |
| HMI-115 240mg | Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use | CFB Week24 Average pill count Tier1 | -0.590 pill | Standard Deviation 1.1144 |
| Placebo | Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use | CFB Week12 Average pill count Tier 1 | -0.384 pill | Standard Deviation 0.8579 |
| Placebo | Change From Baseline (CFB) by Visit in Permitted Rescue Medication Use | CFB Week24 Average pill count Tier1 | -0.414 pill | Standard Deviation 0.9968 |
Secondary
Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP
Endometriosis Daily Impact Pain Scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The higher scores mean worse outcome.
Time frame: Baseline, week 12 and 24
Population: All randomized subjects with at least 1 dose with surgical diagnosis
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| HMI-115 60mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week 12 DYS | -0.83 score on a scale | Standard Error 0.184 |
| HMI-115 60mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week 24 DYS | -0.60 score on a scale | Standard Error 0.192 |
| HMI-115 60mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week12 NMPP | -0.49 score on a scale | Standard Error 0.119 |
| HMI-115 60mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week24 NMPP | -0.42 score on a scale | Standard Error 0.162 |
| HMI-115 60mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week12 DYSP | -0.01 score on a scale | Standard Error 0.169 |
| HMI-115 60mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week24 DYSP | -0.19 score on a scale | Standard Error 0.21 |
| HMI-115 120mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week24 DYSP | -0.69 score on a scale | Standard Error 0.23 |
| HMI-115 120mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week24 NMPP | -0.78 score on a scale | Standard Error 0.165 |
| HMI-115 120mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week 12 DYS | -1.06 score on a scale | Standard Error 0.185 |
| HMI-115 120mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week12 NMPP | -0.61 score on a scale | Standard Error 0.119 |
| HMI-115 120mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week 24 DYS | -0.87 score on a scale | Standard Error 0.194 |
| HMI-115 120mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week12 DYSP | -0.48 score on a scale | Standard Error 0.173 |
| HMI-115 240mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week 24 DYS | -0.66 score on a scale | Standard Error 0.205 |
| HMI-115 240mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week12 NMPP | -0.69 score on a scale | Standard Error 0.128 |
| HMI-115 240mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week24 NMPP | -0.63 score on a scale | Standard Error 0.178 |
| HMI-115 240mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week24 DYSP | -0.28 score on a scale | Standard Error 0.222 |
| HMI-115 240mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week12 DYSP | -0.16 score on a scale | Standard Error 0.187 |
| HMI-115 240mg | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week 12 DYS | -1.13 score on a scale | Standard Error 0.197 |
| Placebo | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week12 DYSP | -0.02 score on a scale | Standard Error 0.149 |
| Placebo | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week24 DYSP | -0.13 score on a scale | Standard Error 0.179 |
| Placebo | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week 24 DYS | -0.48 score on a scale | Standard Error 0.176 |
| Placebo | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week24 NMPP | -0.49 score on a scale | Standard Error 0.149 |
| Placebo | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week 12 DYS | -0.79 score on a scale | Standard Error 0.172 |
| Placebo | Change From Baseline (CFB) in the Monthly Mean Endometriosis Daily Impact Pain Scale for DYS, NMPP and DYSP | Week12 NMPP | -0.46 score on a scale | Standard Error 0.11 |
Secondary
Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change)
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, Week 24
Population: PAS: All randomized subjects with at least 1 dose with surgical diagnosis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| HMI-115 60mg | Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change) | -1.87 score on a scale | Standard Error 0.579 |
| HMI-115 120mg | Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change) | -2.95 score on a scale | Standard Error 0.585 |
| HMI-115 240mg | Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change) | -2.18 score on a scale | Standard Error 0.617 |
| Placebo | Change in Dysmenorrhea(DYS) Measured by Numeric Rating Scale (NRS) From Baseline to Week 24 (Absolute Score Change) | -1.45 score on a scale | Standard Error 0.529 |
Secondary
Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change)
The Numeric Rating Scale for dysmenorrhea ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, Week 24
Population: PAS: All randomized subjects who had at least 1 dose with surgical diagnosis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| HMI-115 60mg | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change) | -6.86 percentage of change from baseline | Standard Error 11.912 |
| HMI-115 120mg | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change) | -21.82 percentage of change from baseline | Standard Error 12.039 |
| HMI-115 240mg | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change) | -14.07 percentage of change from baseline | Standard Error 12.736 |
| Placebo | Change in Dysmenorrhea (DYS) Measured by Numeric Rating Scale(NRS) From Baseline to Week 24 (Percentage Change) | 3.97 percentage of change from baseline | Standard Error 10.898 |
Secondary
Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change)
The Numering Rating Score for dyspareunia ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, week 12 and 24
Population: All randomized subjects with at least 1 dose with surgical diagnosis and responsed having sexual intercourse at both baseline and endpoints
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| HMI-115 60mg | Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change) | Week12 %CFB | -7.01 percentage of change from baseline | Standard Error 19.073 |
| HMI-115 60mg | Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change) | Week24 %CFB | -2.32 percentage of change from baseline | Standard Error 28.065 |
| HMI-115 120mg | Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change) | Week24 %CFB | -61.91 percentage of change from baseline | Standard Error 30.048 |
| HMI-115 120mg | Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change) | Week12 %CFB | -38.43 percentage of change from baseline | Standard Error 20.42 |
| HMI-115 240mg | Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change) | Week12 %CFB | -11.70 percentage of change from baseline | Standard Error 22.342 |
| HMI-115 240mg | Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change) | Week24 %CFB | 3.47 percentage of change from baseline | Standard Error 30.259 |
| Placebo | Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change) | Week12 %CFB | -24.98 percentage of change from baseline | Standard Error 16.627 |
| Placebo | Change in Dyspareunia (DYSP) Measured by NRS From Baseline to Week 12 and 24 (Percentage Change) | Week24 %CFB | -13.17 percentage of change from baseline | Standard Error 22.422 |
Secondary
Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change)
The Numering Rating Score(NRS) for dyspareunia(DYSP) ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, Week12, Week24
Population: All randomized subjects with at least 1 dose with surgical diagnosis and responsed having sexual intercourse at both baseline and endpoints
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| HMI-115 60mg | Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week12 | -0.23 score on a scale | Standard Error 0.487 |
| HMI-115 60mg | Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week 24 | -1.03 score on a scale | Standard Error 0.547 |
| HMI-115 120mg | Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week 24 | -2.13 score on a scale | Standard Error 0.591 |
| HMI-115 120mg | Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week12 | -1.33 score on a scale | Standard Error 0.489 |
| HMI-115 240mg | Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week12 | -0.90 score on a scale | Standard Error 0.518 |
| HMI-115 240mg | Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week 24 | -1.57 score on a scale | Standard Error 0.546 |
| Placebo | Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week12 | -0.54 score on a scale | Standard Error 0.423 |
| Placebo | Change in Dyspareunia (DYSP) Measured by Numering Rating Score(NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week 24 | -0.68 score on a scale | Standard Error 0.456 |
Secondary
Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit
Assessment was based on tampons or pads used. 0 means no bleeding, 4 means heavy bleeding. Higher score means more bleeding.
Time frame: Baseline, week 12 and 24
Population: PAS:All ranomized subjects with at least 1 dose with surgical diagnosis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HMI-115 60mg | Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit | CFB Week 12 Average Score | -0.415 score on a scale | Standard Deviation 0.7062 |
| HMI-115 60mg | Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit | CFB Week 24 Average score | -0.119 score on a scale | Standard Deviation 0.6463 |
| HMI-115 120mg | Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit | CFB Week 24 Average score | -0.390 score on a scale | Standard Deviation 0.8419 |
| HMI-115 120mg | Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit | CFB Week 12 Average Score | -0.571 score on a scale | Standard Deviation 0.6114 |
| HMI-115 240mg | Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit | CFB Week 12 Average Score | -0.363 score on a scale | Standard Deviation 0.6437 |
| HMI-115 240mg | Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit | CFB Week 24 Average score | -0.585 score on a scale | Standard Deviation 0.6965 |
| Placebo | Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit | CFB Week 12 Average Score | -0.197 score on a scale | Standard Deviation 0.4525 |
| Placebo | Change in Menstrual Period Heaviness (Bleeding) From Baseline by Visit | CFB Week 24 Average score | -0.114 score on a scale | Standard Deviation 0.492 |
Secondary
Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change)
The Numeric Rating Scale (NRS) for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, Week12, Week24
Population: PAS: All randomized subjects with at least 1 dose with Surgical diagnosis
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| HMI-115 60mg | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week12 | -1.46 score on a scale | Standard Error 0.344 |
| HMI-115 60mg | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week24 | -1.21 score on a scale | Standard Error 0.452 |
| HMI-115 120mg | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week24 | -2.07 score on a scale | Standard Error 0.457 |
| HMI-115 120mg | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week12 | -1.64 score on a scale | Standard Error 0.347 |
| HMI-115 240mg | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week12 | -1.92 score on a scale | Standard Error 0.373 |
| HMI-115 240mg | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week24 | -1.67 score on a scale | Standard Error 0.49 |
| Placebo | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week12 | -1.36 score on a scale | Standard Error 0.321 |
| Placebo | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Absolute Score Change) | Week24 | -1.26 score on a scale | Standard Error 0.415 |
Secondary
Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change)
The Numeric Rating Scale for non-menstrual pelvic pain (NMPP) ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome.
Time frame: Baseline, week 12 and 24
Population: PAS: All randomized subjects with at least 1 dose with Surgical diagnosis
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| HMI-115 60mg | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change) | Week12 %CFB | -33.74 percentage of change from baseline | Standard Error 10.283 |
| HMI-115 60mg | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change) | Week24 %CFB | -11.22 percentage of change from baseline | Standard Error 15.063 |
| HMI-115 120mg | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change) | Week24 %CFB | -56.62 percentage of change from baseline | Standard Error 15.252 |
| HMI-115 120mg | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change) | Week12 %CFB | -47.48 percentage of change from baseline | Standard Error 10.363 |
| HMI-115 240mg | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change) | Week12 %CFB | -51.66 percentage of change from baseline | Standard Error 11.157 |
| HMI-115 240mg | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change) | Week24 %CFB | -38.05 percentage of change from baseline | Standard Error 16.341 |
| Placebo | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change) | Week12 %CFB | -27.61 percentage of change from baseline | Standard Error 9.577 |
| Placebo | Change in Non-menstrual Pelvic Pain (NMPP) Measured by Numeric Rating Scale (NRS) From Baseline to Week 12 and 24 (Percentage Change) | Week24 %CFB | -33.30 percentage of change from baseline | Standard Error 13.8 |