EndometriosisPhase 3NCT05648669
A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain
A Phase 3 study testing Elagolix in people with Endometriosis, run by Qilu Pharmaceutical (Hainan) Co., Ltd. at 1 site in China.
Trial summary
This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Elagolix
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2022to Feb 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participant understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.
- Participant is premenopausal female, between 18 and 49 years of age (both inclusive), regular menstruation within 3 months before screening.
- Participant clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Screening.
- Participant agrees to use non-hormonal contraception from signing the informed consent through 30 days after last dose of investigational product.
- 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.
- 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].
Who cannot join
- Participant who has a history of sensitivity to elagolix or excipients.
- Participant who blood pregnancy test is positive at screening or on the day of randomization.
- 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).
- Participant who has a history of drug or alcohol abuse within 6 months of screening.
- 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;
- 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.
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- 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).
- 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.
- Participant who has a history of surgical history of hysterectomy, bilateral oophorectomy, procedure that interferes with gastrointestinal mo
- 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.
- 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.
- 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.
- 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.
- Participant who has participated in another investigational study or treatment within 30 days prior to first dose.
- Participant who has previously participated in an elagolix study.
- Participant who has a of abnormal uterine or vaginal bleeding within 3 months prior to Screening.
- Participant who has a history or presence of osteoporosis or other metabolic bone, or clinically significant hypocalcemia, hypo- or hyperphosphatemia at screening.
- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
jinhua Leng
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain
This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain.
Read the detailed description
This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. Participants will be randomised in a 1:1 ratio to receive either elagolix ( 200mg )or placebo. Participants will be administered the study drug up to month 6.
- Conditions
- Endometriosis
- Being tested
- Elagolix, Elagolix placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElagolixDrug
200 mg tablet
Elagolix placeboDrug
Elagolix-matched Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Elagolix | Experimental | Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period Receives: Drug: Elagolix |
| Elagolix placebo | Placebo comparator | Placebo BID for the 6-month Treatment Period Receives: Drug: Elagolix placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Responders of Dysmenorrhea (DYS) at week 12
The criteria for a responder was based on a pre-defined threshold.
Measured: Week12
Percentage of Responders of Non-Menstrual Pelvic Pain (NMPP) at week 12
The criteria for a responder was based on a pre-defined threshold.
Measured: Week12
Secondary outcomes (4)
Safety Specifications in the Treatment Period
Adverse event and serious adverse event
Measured: Baseline, Week24
Change in Numeric Rating Scale (NRS) Scores at week 12
The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Measured: Week12
Change in Dysmenorrhea (DYS) Score at week 24
The DYS pain scale ranges from none to severe.
Measured: Week24
Change in Non-Menstrual Pelvic Pain (NMPP) Score at week 24
The NMPP pain scale ranges from none to severe.
Measured: Week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start4 Sep 2022
- Primary completionJul 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jinhua Leng, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648669
- Sponsor's protocol ID
- QL-YH001-002
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain
- ClinicalTrials.gov ID
- NCT05648669
- Acronym / sponsor ID
- QL-YH001-002
- Conditions
- Endometriosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain.
Detailed description
This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. Participants will be randomised in a 1:1 ratio to receive either elagolix ( 200mg )or placebo. Participants will be administered the study drug up to month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elagolix | Experimental | Drug: ElagolixElagolix 200 mg twice daily (BID) for the 6-month Treatment Period |
| Elagolix placebo | Placebo comparator | Drug: Elagolix placeboPlacebo BID for the 6-month Treatment Period |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participant understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.
- Participant is premenopausal female, between 18 and 49 years of age (both inclusive), regular menstruation within 3 months before screening.
- Participant clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Screening.
- Participant agrees to use non-hormonal contraception from signing the informed consent through 30 days after last dose of investigational product.
- 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.
Key exclusion criteria (19 listed)
- Participant who has a history of sensitivity to elagolix or excipients.
- Participant who blood pregnancy test is positive at screening or on the day of randomization.
- 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).
- Participant who has a history of drug or alcohol abuse within 6 months of screening.
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elagolix200 mg tablet | Drug | Elagolix |
| Elagolix placeboElagolix-matched Placebo tablet | Drug | Elagolix placebo |
Primary outcome
Percentage of Responders of Dysmenorrhea (DYS) at week 12
Time frame: Week12
The criteria for a responder was based on a pre-defined threshold.
Percentage of Responders of Non-Menstrual Pelvic Pain (NMPP) at week 12
Time frame: Week12
The criteria for a responder was based on a pre-defined threshold.
4 secondary outcomes
Safety Specifications in the Treatment Period
Time frame: Baseline, Week24
Change in Numeric Rating Scale (NRS) Scores at week 12
Time frame: Week12
Change in Dysmenorrhea (DYS) Score at week 24
Time frame: Week24
Change in Non-Menstrual Pelvic Pain (NMPP) Score at week 24
Time frame: Week24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jinhua Leng principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Elagolix in people with Endometriosis, run by Qilu Pharmaceutical (Hainan) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jinhua Leng (010-69154116, Lengjenny@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Responders of Dysmenorrhea (DYS) at week 12 (time frame: Week12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.