Endometriosis Clinical Trial
Official title:
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women With Moderate to Severe Endometriosis-Associated Pain Over a 12-Week Treatment Period
Verified date | October 2023 |
Source | Hope Medicine (Nanjing) Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 152 |
Est. completion date | April 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Poland | Specjalistyczna Poradnia Ginekologiczna Gabinet Ginekologiczny Dr med. Janusza Tomaszewskiego | Bialystok | Podlaskie |
Poland | Instytut Matki i Dziecka | Warszawa | Mazowieckie |
United States | Physicians' Research Options, LLC- Corner Canyon Clinic | Draper | Utah |
United States | Tidewater Clinical Research/TPW | Norfolk | Virginia |
Lead Sponsor | Collaborator |
---|---|
Hope Medicine (Nanjing) Co., Ltd |
United States, China, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) from Baseline to Week 12 | The NRS for overall endometriosis-associated pain ranges from 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | Baseline, Week 12 | |
Secondary | Change in DYS measured by NRS from Baseline to Week 24 | The NRS for overall endometriosis-associated pain ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | Baseline, Week 24 | |
Secondary | Change of non-menstrual pelvic pain (NMPP) measured by NRS from Baseline to Week 12 and 24 | The NRS for overall endometriosis-associated pain ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. | Baseline, week 12 and 24 | |
Secondary | Change in dyspareunia (DYSP) measured by NRS from Baseline to Week 12 and 24 | The NRS for overall endometriosis-associated pain ranges 0 (no pain) to 10 (severe pain). Higher scores mean a worse outcome. Higher scores mean a worse outcome. |
Baseline, week 12 and 24 | |
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 | Baseline, week 12 and 24 | |
Secondary | CFB by visit in permitted rescue medication use | Assessment was based on average pill counts | Baseline, week 12 and 24 | |
Secondary | Change in menstrual period heaviness (bleeding) from Baseline by visit | Assessment was based on tampons or pads used | Baseline, week 12 and 24 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01931670 -
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
|
Phase 3 | |
Recruiting |
NCT05648669 -
A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain
|
Phase 3 | |
Completed |
NCT04081532 -
The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain
|
N/A | |
Recruiting |
NCT06101303 -
Endometriosis Pain
|
||
Completed |
NCT04665414 -
Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
|
||
Completed |
NCT03690765 -
Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
|
||
Recruiting |
NCT05153512 -
ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
|
||
Active, not recruiting |
NCT04171297 -
Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
|
||
Recruiting |
NCT04172272 -
The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures
|
N/A | |
Completed |
NCT04565470 -
Strategies of Self-management of Endometriosis Symptoms
|
||
Completed |
NCT03613298 -
Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.
|
N/A | |
Withdrawn |
NCT05568940 -
Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
|
||
Not yet recruiting |
NCT03464799 -
Does Immunotherapy Have a Role in the Management of Endometriosis?
|
||
Active, not recruiting |
NCT03002870 -
Characteristics of Patient Population With Endometriosis
|
N/A | |
Withdrawn |
NCT03272360 -
Endometriosis Biomarker Discovery Study
|
N/A | |
Completed |
NCT02973854 -
Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
|
||
Recruiting |
NCT02481739 -
Laparoscopic Surgical Management of Endometriosis on Fertility
|
N/A | |
Active, not recruiting |
NCT02754648 -
Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve
|
N/A | |
Completed |
NCT06106932 -
GnRH-a on Angiogenesis of Endometriosis
|
N/A | |
Completed |
NCT02387931 -
Supplementation in Adolescent Girls With Endometriosis
|
Phase 4 |