Heavy Menstrual BleedingPhase 3NCT06671548
Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
A Phase 3 study testing Relugolix in people with Heavy Menstrual Bleeding and Uterine Fibroids, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to determine the benefit of relugolix 40 milligrams (mg) once a day compared with placebo in heavy menstrual bleeding associated with uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Heavy Menstrual Bleeding, Uterine Fibroids
- What is being tested?
- Relugolix
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 7 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Premenopausal female aged 18 or older
- Diagnosis of uterine fibroids confirmed by transvaginal/rectal ultrasound during the screening period
- Heavy menstrual bleeding caused by uterine fibroids
- Breast ultrasound results during the screening period meet the BI-RADS classification of 1 to 3
- Able to understand and comply with the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing
Who cannot join
- History of bilateral oophorectomy, or planned to undergo hysterectomy, bilateral oophorectomy, or other surgical procedures during the study period.
- Previous treatment with gonadotropin-releasing hormone (GnRH) agonists or GnRH antagonists for uterine fibroids has failed.
- History of or current osteoporosis or other metabolic bone disease.
- History of malignant tumor within 5 years prior to screening, except for cured skin cancer, basal cell carcinoma, and other localized malignant tumors.
- History of drug abuse, alcohol abuse, or drug dependence within 2 years prior to screening.
- Presence of an in situ copper intrauterine device (IUD) or a progestin-containing IUD implant/subdermal contraceptive implant during the screening period; subjects who can remove the IUD/subdermal contraceptive implant at least 1 month before enrollment may be allowed to participate.
- Baseline bone mineral density Z-score of < -2.0 at the lumbar spine, total hip, or femoral neck during the screening period.
- Any other factors that the investigator deems unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Yu Qi
About this study
Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Designed Efficacy and Safety Study to Evaluate Relugolix Tablets in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The goal of this clinical trial is to determine the benefit of relugolix 40 milligrams (mg) once a day compared with placebo in heavy menstrual bleeding associated with uterine fibroids. The main question[s] it aims to answer are:
- the benefit of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids
- the safety of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids
Read the detailed description
This study is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-designed efficacy and safety study to evaluate 12 weeks of oral daily relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg (the treatment group) or 12 weeks of daily oral relugolix 40 mg placebo (the placebo group) followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg.
Approximately 120 women with heavy menstrual bleeding associated with uterine fibroids will be enrolled and randomized 2:1 to the treatment group (N=80) or placebo group (N=40).
Stratification variables will include mean screening menstrual blood loss volume (< 225 mL versus ≥ 225 mL) by the alkaline hematin method.
The study consists of a screening period (up to ~13 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (12 weeks) and a follow-up period (4w).
Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms, and assessments of bone mineral density.
- Conditions
- Heavy Menstrual Bleeding, Uterine Fibroids
- Being tested
- Relugolix, Relugolix placebo
- Medical subject headings
- Menorrhagia, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelugolixDrug
Also called megestrol acetate, medroxyprogesterone acetate
- Relugolix (40 mg) tablet administered orally once daily；
- megestrol acetate (1 mg) administered orally once daily；
- medroxyprogesterone acetate (2 mg) administered orally once daily
Relugolix placeboDrug
Also called megestrol acetate placebo, medroxyprogesterone acetate placebo
Relugolix (0 mg) tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
megestrol acetate (0 mg) administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
medroxyprogesterone acetate (0 mg) administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
| Study group | Role | What they receive |
|---|---|---|
| Relugolix plus megestrol acetate/medroxyprogesterone acetate (the treatment group) | Experimental | Relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg for 12 weeks followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg.. Receives: Drug: Relugolix |
| Placebo (the placebo group) | Placebo comparator | Relugolix 40 mg placebo co-administered with megestrol acetate 1 mg placebo and medroxyprogesterone acetate 2 mg placebo for 12 weeks followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg. Receives: Drug: Relugolix placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And ≥ 50% Reduction From Baseline MBL Volume
A responder was a participant who had MBL volume of < 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of the double-blind treatment period. All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 12/early termination feminine product collection interval (up to 35 days prior to the last dose of double-blind treatment). The percentage of participants who were responders are presented.
As per the objective of the study, the pre-specified primary efficacy analyses compared relugolix plus megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg with placebo. Therefore, only relugolix plus megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg and placebo arms are presented.
Measured: From Baseline up to the last 35 days of the double-blind treatment period
Secondary outcomes (1)
Percentage Of Participants With Amenorrhea Over The Last 35 Days Of the double-blind treatment period
Following the administration of the investigational product, amenorrhea was defined as the central laboratory-confirmed measurement of blood loss volume <5 mL (including no bleeding) over a continuous 56-day period using feminine products.
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg with placebo. Therefore, only relugolix plus megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg and placebo arms are presented.
Measured: From Baseline up to the last 35 days of the double-blind treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start15 Jan 2024
- Primary completion12 Nov 2026 (estimated)
- Study completion7 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671548
- Sponsor's protocol ID
- QLG1079-301
- Status last verified
- Jan 2026
- First submitted
- 1 Nov 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Designed Efficacy and Safety Study to Evaluate Relugolix Tablets in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
- ClinicalTrials.gov ID
- NCT06671548
- Acronym / sponsor ID
- QLG1079-301
- Conditions
- Heavy Menstrual Bleeding, Uterine Fibroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 12 Nov 2026 (estimated)
- Study completion
- 7 Jan 2027 (estimated)
- First posted
- 4 Nov 2024 (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.
The goal of this clinical trial is to determine the benefit of relugolix 40 milligrams (mg) once a day compared with placebo in heavy menstrual bleeding associated with uterine fibroids. The main question[s] it aims to answer are:
- the benefit of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids
- the safety of relugolix 40 mg once daily in women with heavy menstrual bleeding associated with uterine fibroids
Detailed description
This study is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-designed efficacy and safety study to evaluate 12 weeks of oral daily relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg (the treatment group) or 12 weeks of daily oral relugolix 40 mg placebo (the placebo group) followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg.
Approximately 120 women with heavy menstrual bleeding associated with uterine fibroids will be enrolled and randomized 2:1 to the treatment group (N=80) or placebo group (N=40).
Stratification variables will include mean screening menstrual blood loss volume (< 225 mL versus ≥ 225 mL) by the alkaline hematin method.
The study consists of a screening period (up to ~13 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (12 weeks) and a follow-up period (4w).
Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms, and assessments of bone mineral density.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relugolix plus megestrol acetate/medroxyprogesterone acetate (the treatment group) | Experimental | Drug: RelugolixRelugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg for 12 weeks followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg.. |
| Placebo (the placebo group) | Placebo comparator | Drug: Relugolix placeboRelugolix 40 mg placebo co-administered with megestrol acetate 1 mg placebo and medroxyprogesterone acetate 2 mg placebo for 12 weeks followed by 12 weeks of daily oral relugolix 40 mg co-administered with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Premenopausal female aged 18 or older
- Diagnosis of uterine fibroids confirmed by transvaginal/rectal ultrasound during the screening period
- Heavy menstrual bleeding caused by uterine fibroids
- Breast ultrasound results during the screening period meet the BI-RADS classification of 1 to 3
- Able to understand and comply with the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing
Key exclusion criteria (8 listed)
- History of bilateral oophorectomy, or planned to undergo hysterectomy, bilateral oophorectomy, or other surgical procedures during the study period.
- Previous treatment with gonadotropin-releasing hormone (GnRH) agonists or GnRH antagonists for uterine fibroids has failed.
- History of or current osteoporosis or other metabolic bone disease.
- History of malignant tumor within 5 years prior to screening, except for cured skin cancer, basal cell carcinoma, and other localized malignant tumors.
- History of drug abuse, alcohol abuse, or drug dependence within 2 years prior to screening.
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 |
|---|---|---|
| RelugolixAlso: megestrol acetate, medroxyprogesterone acetate* Relugolix (40 mg) tablet administered orally once daily； * megestrol acetate (1 mg) administered orally once daily； * medroxyprogesterone acetate (2 mg) administered orally once daily | Drug | Relugolix plus megestrol acetate/medroxyprogesterone acetate (the treatment group) |
| Relugolix placeboAlso: megestrol acetate placebo, medroxyprogesterone acetate placeboRelugolix (0 mg) tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor. megestrol acetate (0 mg) administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor. medroxyprogesterone acetate (0 mg) administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor. | Drug | Placebo (the placebo group) |
Primary outcome
Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And ≥ 50% Reduction From Baseline MBL Volume
Time frame: From Baseline up to the last 35 days of the double-blind treatment period
A responder was a participant who had MBL volume of < 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of the double-blind treatment period. All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 12/early termination feminine product collection interval (up to 35 days prior to the last dose of double-blind treatment). The percentage of participants who were responders are presented. As per the objective of the study, the pre-specified primary efficacy analyses compared relugolix plus megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg with placebo. Therefore, only relugolix plus megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg and placebo arms are presented.
1 secondary outcome
Percentage Of Participants With Amenorrhea Over The Last 35 Days Of the double-blind treatment period
Time frame: From Baseline up to the last 35 days of the double-blind treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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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.
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 Relugolix in people with Heavy Menstrual Bleeding and Uterine Fibroids, run by Qilu Pharmaceutical 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Yu, PhD (+086-010-69154116, yuqimd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And ≥ 50% Reduction From Baseline MBL Volume (time frame: From Baseline up to the last 35 days of the double-blind treatment period). 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 2 Feb 2026.