A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain
NCT ID: NCT05648669
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
336 participants
INTERVENTIONAL
2022-09-04
2024-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Elagolix
Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period
Elagolix
200 mg tablet
Elagolix placebo
Placebo BID for the 6-month Treatment Period
Elagolix placebo
Elagolix-matched Placebo tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Elagolix
200 mg tablet
Elagolix placebo
Elagolix-matched Placebo tablet
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participant is premenopausal female, between 18 and 49 years of age (both inclusive), regular menstruation within 3 months before screening.
3. Participant clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Screening.
4. Participant agrees to use non-hormonal contraception from signing the informed consent through 30 days after last dose of investigational product.
5. Participant cervical smear is normal or abnormal without clinical significance (normal cervical smear within 6 months prior to screening; or participant is virgin and decides not to undergo cervical smear); Atypical Squamous Cells of Undetermined Significance (ASCUS) may be combined with human papillomavirus (HPV) testing. ASCUS participants may be included if they are negative for high-risk HPV.
6. Participant who is 40 years or older in age has a normal or abnormal without clinical significance mammogram at screening or within 6 months prior to screening \[Breast Imaging Reporting Data System (BI-RADS) classification 1-3 or equivalent\].
Exclusion Criteria
2. Participant who blood pregnancy test is positive at screening or on the day of randomization.
3. Participant who has an intra-uterine device (IUD) or contraceptive sub-dermal implant (If the IUD or sub-dermal implant is removed at least 30 days, participant may be screened for the study).
4. Participant who has a history of drug or alcohol abuse within 6 months of screening.
5. Participant who is hepatitis B patient \[hepatitis B surface antigen (HbsAg) positive and detection of HBV-DNA suggests viral replication\]; hepatitis C patients \[hepatitis C virus (HCV) antibody positive and detection of HCV-RNA suggests viral replication\]; syphilis screening positive (except for specific antibody detection positive, non-specific antibody detection negative and confirmed as inactive infection in combination with clinical judgment), known history of human immunodeficiency virus (HIV) positive or HIV screening positive;
6. Participant who has used moderate or strong inducers of cytochrome P450 3A or inhibitors of organic anion transporting polypeptide 1B1 (OATP1B1) within 30 days prior to first dose.
7. Participant who has unstable medical diseases in the opinion of the investigator (e.g. uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled seizures, angina unstable, inflammatory bowel disease, hyperprolactinemia, malignancy, or significant infection).
8. Participant who has a history of major depression or post-traumatic stress disorder within 2 years of screening or a history of other major psychiatric disorder.
9. Participant who has a history of surgical history of hysterectomy, bilateral oophorectomy, procedure that interferes with gastrointestinal mo
10. Participant who in the opinion of the investigator has a history of previous non-response to gonadotropin-releasing hormone agonists, antagonists. tility, any recent major or minor surgery.
11. Participant who need to use rescue analgesic drugs other than those specified in the protocol, or disagree to use rescue analgesic drugs specified in the protocol during the screening period and treatment period.
12. Participant who has any other chronic pain syndrome that requires chronic analgesic or other chronic therapy, which, in the opinion of the investigator, would interfere with the assessment of endometriosis-related pain.
13. Participant who has used of any systemic steroids for more than 2 weeks within 3 months prior to screening or is likely to require such treatment during the course of the study. Over-the-counter and prescription topical, inhaled or nasal corticosteroids are allowed.
14. Participant who has participated in another investigational study or treatment within 30 days prior to first dose.
15. Participant who has previously participated in an elagolix study.
16. Participant who has a of abnormal uterine or vaginal bleeding within 3 months prior to Screening.
17. Participant who has a history or presence of osteoporosis or other metabolic bone, or clinically significant hypocalcemia, hypo- or hyperphosphatemia at screening.
18. Participant who has dual-energy x-ray (DXA) absorptiometry scan results of the lumbar spine (L1-L4), femoral neck, or total hip bone mineral density (BMD) below normal 2.0 or more at screening (Z-score for patients \< 40 years, T-score for patients ≥ 40 years).
19. Participant who may increase study-related risks or interfere with the interpretation of study results in the opinion of the investigator, who are considered unsuitable for enrollment by the investigator and/or the sponsor.
18 Years
49 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Qilu Pharmaceutical (Hainan) Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
jinhua Leng
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
jinhua Leng
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
QL-YH001-002
Identifier Type: -
Identifier Source: org_study_id