EndometriosisPhase 3NCT06076486
A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated Pain
A Phase 3 study testing Elagolix in people with Endometriosis, run by Nanjing Chia-tai Tianqing Pharmaceutical at 1 site in China.
Trial summary
This is a phase 3, multicenter, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of elagolix tablets versus placebo in premenopausal women with moderate or 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
- 202 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2023to 2 Apr 2025
- 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
- Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.
- Diagnosis of endometriosis by pathological diagnosis or surgery within 10 years prior to screening by laparoscopy or exploratory laparotomy; or diagnosis of endometriosis based on clinical presentation of endometriosis in combination with previous imaging studies according to Endometriosis Diagnosis and Treatment Guidelines (Third Edition).
- Premenopausal female aged 18 and 49 years (both inclusive) with one complete menstruation prior to screening record in the diary for at least 35 days and at least one complete menstrual cycle before the first dosing.
- Agree to take only protocol-specified permitted rescue analgesic medications during the screening and treatment Periods.
- Cervical smear is normal or abnormal without clinical significance (acceptance of normal cervical smear within 6 months prior to screening; or participant is virgin and decides not to take cervical smear); ASCUS may be combined with HPV testing. ASCUS participants may be included if they are negative for high-risk HPV.
- Agree to use non-hormonal contraception from signing the informed consent through 1 month after last dosing.
Who cannot join
- Subjects with a history of sensitivity to elagolix or excipients; or with a known history of serious, life-threatening or significant allergy to any drug.
- Previous non-responders to GnRH agonist or GnRH antagonist therapy as judged by the investigator.
- Subjects with a history of previous or existing osteoporosis or other metabolic bone disease; or previous abnormal clinically significant hypocalcemia, hypophosphatemia or hyperphosphatemia; or DXA Z score (subjects < 40 years old) or T score (subjects ≥ 40 years old) of lumbar spine (L1-L4), femoral neck or total hip BMD is < -2.0;
- Subjects with unstable diseases (such as poorly controlled diabetes, poorly controlled hypertension, poorly controlled seizures, unstable angina pectoris, inflammatory bowel disease, hyperprolactinemia, malignant tumors (except basal cell carcinoma of the skin) or severe infection, etc.) unuitable for the study at screening as judged by the investigators;
- Subjects with a history of hysterectomy, oophorectomy, or surgery affecting drug absorption; or those who plan to undergo the above surgery during the trial;
- Subjects with a history of major depressive disorder or post-traumatic stress disorder within 2 years prior to screening or other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder); or history of suicidal behavior or suicidality; or suicidality as judged by the investigators;
Show all 21Show fewer
- Subjects with undiagnosed vaginal and/or uterine bleeding within 3 months prior to screening;
- Subjects with other chronic pain syndromes requiring chronic analgesia or other long-term treatment that would be expected to interfere with the assessment of endometriosis-related pain;
- Subjects with a history of drug or alcohol abuse within 6 months prior to screening;
- Subjects aged ≥ 40 years with abnormal results of breast ultrasonography during the screening period or within 1 year prior to screening (BI-RADS classification grade 4 and above);
- Clinically significant gynecological conditions (e.g., any non-malignant cyst > 6 cm, or malignant cyst) by TVU or transrectal ultrasound or transabdominal ultrasound at screening;
- Subjects with hepatitis B [HbsAg is positive and detection of HBV-DNA indicates viral replication], hepatitis C [HCV antibody is positive and detection of HCV-RNA indicates viral replication], positive syphilis (except specific antibody detection positive, non-specific antibody detection negative and confirmed as inactive infection in combination with clinical judgment), known HIV positive history or HIV positive;
- Subjects with moderate/severe liver injury caused by previous diseases, or AST or ALT or bilirubin ≥ 2 × ULN at screening;
- Subjects requiring the use of a prohibited long-acting anesthetic or immediate-release anesthetic for more than 2 consecutive weeks for the treatment of endometriosis-related pain within 6 months prior to screening;
- Participation in any other interventional clinical trial (including drug and device clinical trials) within 1 month prior to screening;
- Use of any systemic corticosteroids for more than 2 weeks within 3 months prior to screening or likely to require such therapy during the study (topical, inhaled, or nasal corticosteroids are allowed);
- Use of GnRH agonists or GnRH antagonists (including participation in clinical trails of elagolix) within 6 months prior to screening; use of medroxyprogesterone acetate, danazol, aromatase inhibitors within 3 months prior to screening; use of oral contraceptives, or any hormonal treatment for endometriosis within 2 months prior to screening; use of Chinese herbal medicine for endometriosis treatment or symptom relief within 1 month prior to screening;
- Subjects with IUD or subcutaneous contraceptive implants (the IUD or subcutaneous contraceptive implants removed more than 30 days prior to screening is allowed);
- Subjects taking moderate or strong CYP450 3A inducers or OATP1B1 inhibitors within 1 month prior to the first dosing;
- Pregnant or lactating women; or plan to have children during the trial (from signing the informed consent form to 3 months after using the study drug); or < 6 months after delivery; or < 3 months after abortion; or have a positive pregnancy test result during the screening period or on the day of randomization;
- Subjects with increasing risk associated with the study, interference with the interpretation of study results, or inappropriate as judged by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Elagolix Tablets in Patients With Moderate or Severe Endometriosis-associated Pain
This is a phase 3, multicenter, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of elagolix tablets versus placebo in premenopausal women with moderate or severe endometriosis-associated pain.
- 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
Elagolix 200 mg tablets administered orally BID
Elagolix placeboDrug
Elagolix placebo administered orally BID
| Study group | Role | What they receive |
|---|---|---|
| Elagolix 200 mg BID | Experimental | Participants received elagolix 200 mg tablets twice a day (BID) Receives: Drug: Elagolix |
| Elagolix placebo | Placebo comparator | Participants received elagolix placebo twice a day (BID) 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 responder was defined as reaching a pre-defined threshold.
Measured: 12 weeks
Percentage of responders of Non-Menstrual Pelvic Pain (NMPP) at week 12
The responder was defined as reaching a pre-defined threshold.
Measured: 12 weeks
Secondary outcomes (7)
Change from baseline in DYS
The DYS pain scale s range from 0 (none) to 3 (severe).
Measured: Through study completion, an average of 24 weeks
Change from baseline in NMPP
The NMPP pain scales range from 0 (none) to 3 (severe).
Measured: Through study completion, an average of 24 weeks
Change from baseline in Dyspareunia (DYSP)
The DYSP pain scales range from 0 (none) to 3 (severe).
Measured: Through study completion, an average of 24 weeks
Change from baseline in Numeric Rating Scale (NRS) scores
The NRS pain scores ranges 0 (none) to 10 (worst pain ever).
Measured: Through study completion, an average of 24 weeks
Change from baseline in rescue analgesic use
Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the subject daily as the total number of pills/tablets of each type taken within a 24-hour period.
Measured: Through study completion, an average of 24 weeks
Percentage of participants with a Patient Global Impression of Change (PGIC) response
PGIC response was defined as very much improved and much improved selected by the subject to assess the change in endometriosis-associated pain since the initiation of study drug.
Measured: Through study completion, an average of 24 weeks
Safety Specifications in the Treatment Period
AEs and SAEs occurred during the treatment period.
Measured: Through study completion, an average of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start14 Sep 2023
- Primary completion22 Nov 2024
- Study completion2 Apr 2025
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.
- More trials run by Nanjing Chia-tai Tianqing PharmaceuticalThe sponsor's other registered studies.
- 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yingfang Zhou, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076486
- Sponsor's protocol ID
- ALGKNP2022-III
- Status last verified
- Apr 2025
- First submitted
- 13 Sep 2023
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. 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 Tablets in Patients With Moderate or Severe Endometriosis-associated Pain
- ClinicalTrials.gov ID
- NCT06076486
- Acronym / sponsor ID
- ALGKNP2022-III
- Conditions
- Endometriosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Nanjing Chia-tai Tianqing PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 10 Oct 2023 (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 evaluate the efficacy and safety of elagolix tablets versus placebo in premenopausal women with moderate or severe endometriosis-associated pain.
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 200 mg BID | Experimental | Drug: ElagolixParticipants received elagolix 200 mg tablets twice a day (BID) |
| Elagolix placebo | Placebo comparator | Drug: Elagolix placeboParticipants received elagolix placebo twice a day (BID) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent.
- Diagnosis of endometriosis by pathological diagnosis or surgery within 10 years prior to screening by laparoscopy or exploratory laparotomy; or diagnosis of endometriosis based on clinical presentation of endometriosis in combination with previous imaging studies according to Endometriosis Diagnosis and Treatment Guidelines (Third Edition).
- Premenopausal female aged 18 and 49 years (both inclusive) with one complete menstruation prior to screening record in the diary for at least 35 days and at least one complete menstrual cycle before the first dosing.
- Agree to take only protocol-specified permitted rescue analgesic medications during the screening and treatment Periods.
- Cervical smear is normal or abnormal without clinical significance (acceptance of normal cervical smear within 6 months prior to screening; or participant is virgin and decides not to take cervical smear); ASCUS may be combined with HPV testing. ASCUS participants may be included if they are negative for high-risk HPV.
Key exclusion criteria (21 listed)
- Subjects with a history of sensitivity to elagolix or excipients; or with a known history of serious, life-threatening or significant allergy to any drug.
- Previous non-responders to GnRH agonist or GnRH antagonist therapy as judged by the investigator.
- Subjects with a history of previous or existing osteoporosis or other metabolic bone disease; or previous abnormal clinically significant hypocalcemia, hypophosphatemia or hyperphosphatemia; or DXA Z score (subjects < 40 years old) or T score (subjects ≥ 40 years old) of lumbar spine (L1-L4), femoral neck or total hip BMD is < -2.0;
- Subjects with unstable diseases (such as poorly controlled diabetes, poorly controlled hypertension, poorly controlled seizures, unstable angina pectoris, inflammatory bowel disease, hyperprolactinemia, malignant tumors (except basal cell carcinoma of the skin) or severe infection, etc.) unuitable for the study at screening as judged by the investigators;
- Subjects with a history of hysterectomy, oophorectomy, or surgery affecting drug absorption; or those who plan to undergo the above surgery during the trial;
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 |
|---|---|---|
| ElagolixElagolix 200 mg tablets administered orally BID | Drug | Elagolix 200 mg BID |
| Elagolix placeboElagolix placebo administered orally BID | Drug | Elagolix placebo |
Primary outcome
Percentage of responders of dysmenorrhea (DYS) at week 12
Time frame: 12 weeks
The responder was defined as reaching a pre-defined threshold.
Percentage of responders of Non-Menstrual Pelvic Pain (NMPP) at week 12
Time frame: 12 weeks
The responder was defined as reaching a pre-defined threshold.
7 secondary outcomes
Change from baseline in DYS
Time frame: Through study completion, an average of 24 weeks
Change from baseline in NMPP
Time frame: Through study completion, an average of 24 weeks
Change from baseline in Dyspareunia (DYSP)
Time frame: Through study completion, an average of 24 weeks
Change from baseline in Numeric Rating Scale (NRS) scores
Time frame: Through study completion, an average of 24 weeks
Change from baseline in rescue analgesic use
Time frame: Through study completion, an average of 24 weeks
Percentage of participants with a Patient Global Impression of Change (PGIC) response
Time frame: Through study completion, an average of 24 weeks
Safety Specifications in the Treatment Period
Time frame: Through study completion, an average of 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Yingfang Zhou principal investigator
Peking University First 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 Nanjing Chia-tai Tianqing Pharmaceutical 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 21 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: finished, as of the sponsor's last update on 23 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: 12 weeks). 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 23 Sep 2025.