A Phase 3 interventional study of Relugolix and Estradiol/norethindrone acetate in Heavy Menstrual Bleeding and Uterine Fibroid, sponsored by Myovant Sciences GmbH. Completed at 150 sites in 9 countries. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Myovant Sciences GmbH (part of Sumitomo Pharma Co., Ltd.) · Phase 3, Interventional, and Treatment
Among 85 studies in Menorrhagia with a site in United States — 8 open to participants now, 10 under way, none of them phase 3. Menorrhagia · United States.
Among the 85 studies in Menorrhagia with a site in United States, this one is the 7th largest by enrollment of the 71 interventional ones that give a count, is one of 8 that started in 2017, is one of 22 in phase 3, and was the 59th registered.
206 studies on the registry are indexed under Menorrhagia; 35 are open to participants now.
Browse Menorrhagia studies →8 of the 85 studies in Menorrhagia with a site in United States are open now. Recruiting first, the newest first:
Alnylam Pharmaceuticals · Sites in United States, Netherlands, Sweden and 2 more countries
Spark Biomedical, Inc. · Sites in United States
Oregon Health and Science University · Sites in United States
University of Colorado, Colorado Springs · Sites in United States
Channel Medsystems · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 23 Menorrhagia studies recruiting now, 4 (17%) set no upper age limit and 19 (83%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 50 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
85 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 5 · Phase 3 22 · Phase 4 16
First in 2001; this study’s year is marked. 8 started in 2017.
This study's enrollment of 477 is above the median of 95 across 149 interventional studies indexed under Menorrhagia.
Median enrollment 82 across the 71 interventional studies, 256 across the 14 observational. Of the 66 that completed or were terminated, 40 (61%) have results posted.
This tab as a report to print or save as PDF → With an account.
43 of 85 have an industry lead sponsor. The 10 most frequent:
Myovant Sciences GmbH is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 6 (60%) have results posted.
Myovant Sciences GmbH has 5 studies filed under Menorrhagia — fewer than ten, so there is no comparison to draw.
3 of the studies in Menorrhagia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT07575308Alnylam PharmaceuticalsHMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB | 2027-06-30 |
| NCT07326722Spark Biomedical, Inc.Delivering tAN to Reduce HMB: The LUNA Study | 2027-08-31 |
Among the 85 studies in Menorrhagia with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the pivotal studies (MVT-601-3001 or MVT-601-3002).
This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that enrolled eligible participants who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled pivotal studies, MVT-601-3001 (LIBERTY 1 - NCT03049735) or MVT-601-3002 (LIBERTY 2 - NCT 03103087). All participants received relugolix 40 mg orally once daily co-administered with E2 (1 mg) and NETA (0.5 mg) for 28 weeks.
Approximately 600 women with heavy menstrual bleeding associated with uterine fibroids were to be enrolled, after having completed a 24-week treatment period in one of the pivotal studies. The objectives of the study were to evaluate long-term efficacy and safety through up to 52 weeks of treatment (including treatment during the pivotal study) of relugolix co-administered with E2/NETA.
Screening and baseline procedures were to be done at the same visit for this extension study (referred to as the "Week 24/Baseline Visit"), which coincided with the Week 24 Visit from the pivotal study and was to be defined as the date of completion of the last Week 24 procedure in the pivotal study. Participants will have received their last dose of study drug in the pivotal study on the day prior to the Week 24/Baseline Visit and were to receive their first dose of study drug for this extension study in the clinic after the participant was determined to be eligible for this extension study and provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3003 was to define enrollment into this study. Study participants were to then take the open-label study treatment orally once daily for 28 weeks.
Key Inclusion Criteria:
Key Exclusion Criteria:
Relugolix co-administered with E2/NETA for 28 weeks.
Drug: Relugolix · Drug: Estradiol/norethindrone acetate
Relugolix 40-mg tablet administered orally once daily
Also known as: MVT-601, TAK-385
Drug pages: Estradiol · Norethindrone Acetate
Capsule containing co-formulated tablet of E2 (1 mg) and NETA (0.5 mg) administered orally once daily
Also known as: E2/NETA
Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment
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 treatment (up to Week 52). 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 52/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented.
Time frame: Week 52/End of Treatment
Change From Pivotal Study Baseline In MBL Volume At Week 52
MBL volume was measured using the alkaline hematin method, which involves chemically measuring the blood content of used feminine products. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The least squares (LS) mean was derived for each treatment group using a mixed-effects model with repeated measure with visit, region, and Baseline MBL as fixed effects.
Time frame: Week 52
Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment
Amenorrhea was defined as meeting 1 of the following criteria for 2 consecutive visits: * No feminine product returned due to reported amenorrhea; * No feminine product returned due to reports of spotting/negligible bleeding coupled with other data (participant's paper diary) indicating infrequent non-cyclic bleeding/spotting; and * Feminine product collection with a negligible observed MBL volume coupled with data (participant's paper diary) indicating infrequent non-cyclic bleeding/spotting.
Time frame: Week 24 up to last 35 days of treatment (up to Week 52)
Percentage Of Participants With A Hemoglobin Level ≤10.5 Gram/Deciliter (g/dL) At Pivotal Study Baseline Who Achieved An Increase Of >2 g/dL From Pivotal Study Baseline At Week 52
Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤10.5 g/dL at pivotal study Baseline and reported at Week 52.
Time frame: Week 52
Number Of Participants With Hemoglobin Increase Of ≥1 g/dL From Pivotal Study Baseline At Week 52 Among Those With A Hemoglobin Concentration Below Lower Limit Of Normal At Pivotal Baseline
Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin concentration below the lower limit of normal (11.6 g/dL) at pivotal study Baseline and reported at Week 52.
Time frame: Week 52
Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52
Blood samples were collected from participants for hemoglobin measurements. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52
Transformed score ranges from 0 to 100 based on Likert scale (none of time, a little of time, some of the time, most of the time, and all of the time). Lower score indicates less distress and higher score indicates greater distress. A negative change from baseline indicates improvement. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52
Assessed using the UFS-QoL questionnaire. The UFS-QoL subscale scores include items related to uterine fibroid-associated limitations/impairment in activities, revised activities, concern, energy/mood, control, self-consciousness, and sexual function. The scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Change From Pivotal Study Baseline In The UFS-QoL Score By Health-Related Quality of Life Total Score At Week 52
Assessed using the UFS-QoL Questionnaire. The UFS-QoL total score was the sum of the subscales (concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function). The raw scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Change From Pivotal Study Baseline In The Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QoL) Bleeding And Pelvic Discomfort (BPD) Scale At Week 52
The BPD scale has been derived from the UFS-QoL symptom severity scale. The scale consists of the following 3 symptoms proximal to uterine fibroids that are experienced by most participants: heavy bleeding during the menstrual period (Question 1), passing blood clots during the menstrual period (Question 2), and feeling tightness or pressure in the pelvic area (Question 5). Raw scores were transformed to a normalized score, with a range of possible scores from 0 to 100 (none of time, a little of time, some of the time, most of the time, and all of the time), where higher scores values are indicative of greater distress and lower scores are indicative of minimal distress. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Change From Pivotal Study Baseline In Uterine Volume At Week 52
Volume of the uterus was measured by transvaginal or transabdominal ultrasound. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Change From Pivotal Study Baseline In Uterine Fibroid Volume At Week 52
Volume of the primary uterine fibroid was measured by transvaginal or transabdominal ultrasound. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52
Assessed by dual-energy X-ray absorptiometry (DXA) scan at the lumbar spine (L1-L4), total hip, and femoral neck at pivotal study Baseline and at Week 52. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
Time frame: Week 52
Change From Pivotal Study Baseline In Predose Serum E2 Concentrations At Week 52
Blood samples were collected from participants at predose for E2 measurements. These were analyzed at a central laboratory.
Time frame: Week 52
Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52
The EQ-5D-5L scale is a standardized instrument for use as a measure of health outcomes. Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression were each assessed on 5-point categorical scales of no problems to unable to complete specified activity, or no pain/discomfort to extreme pain/discomfort, or not anxious/depressed to extremely anxious/depressed. The change from baseline is summarized by amount of improvement (1-4 categories), amount of deterioration (1-4 categories), or no change.
Time frame: Week 52
All participants who completed their participation in one of the pivotal studies (MVT-601-3001 or MVT-601-3002) were eligible to enroll in this study.
| Milestone | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Started | 163 | 150 | 164 |
| Received at least 1 dose of study drug | 163 | 149 | 164 |
| Completed | 133 | 108 | 122 |
| Not completed | 30 | 42 | 42 |
| Withdrew: Adverse event | 5 | 5 | 9 |
| Withdrew: Protocol deviation | 2 | 1 | 2 |
| Withdrew: Lost to follow-up | 7 | 10 | 10 |
| Withdrew: Withdrawal by subject | 9 | 12 | 11 |
| Withdrew: Lack of efficacy | 2 | 7 | 5 |
| Withdrew: Other | 5 | 6 | 5 |
| Withdrew: Participants who did not receive any study drug | 0 | 1 | 0 |
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 treatment (up to Week 52). 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 52/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment | 86.50 (80.28 to 91.34) | 79.87 (72.52 to 85.98) | 75.00 (67.65 to 81.42) |
MBL volume was measured using the alkaline hematin method, which involves chemically measuring the blood content of used feminine products. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The least squares (LS) mean was derived for each treatment group using a mixed-effects model with repeated measure with visit, region, and Baseline MBL as fixed effects.
| mL | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From Pivotal Study Baseline In MBL Volume At Week 52 | -251.6 ± 16.38 | -219.1 ± 13.91 | -204.7 ± 13.31 |
Amenorrhea was defined as meeting 1 of the following criteria for 2 consecutive visits: * No feminine product returned due to reported amenorrhea; * No feminine product returned due to reports of spotting/negligible bleeding coupled with other data (participant's paper diary) indicating infrequent non-cyclic bleeding/spotting; and * Feminine product collection with a negligible observed MBL volume coupled with data (participant's paper diary) indicating infrequent non-cyclic bleeding/spotting.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment | 70.55 (62.92 to 77.42) | 68.46 (60.35 to 75.82) | 57.93 (49.98 to 65.58) |
Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤10.5 g/dL at pivotal study Baseline and reported at Week 52.
| percentage of participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Percentage Of Participants With A Hemoglobin Level ≤10.5 Gram/Deciliter (g/dL) At Pivotal Study Baseline Who Achieved An Increase Of >2 g/dL From Pivotal Study Baseline At Week 52 | 58.97 (42.10 to 74.43) | 78.95 (62.68 to 90.45) | 42.11 (26.31 to 59.18) |
Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin concentration below the lower limit of normal (11.6 g/dL) at pivotal study Baseline and reported at Week 52.
| participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Number Of Participants With Hemoglobin Increase Of ≥1 g/dL From Pivotal Study Baseline At Week 52 Among Those With A Hemoglobin Concentration Below Lower Limit Of Normal At Pivotal Baseline | 56 | 60 | 45 |
Blood samples were collected from participants for hemoglobin measurements. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
| g/dL | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52 | 2.7 ± 0.24 | 3.0 ± 0.23 | 1.9 ± 0.22 |
Transformed score ranges from 0 to 100 based on Likert scale (none of time, a little of time, some of the time, most of the time, and all of the time). Lower score indicates less distress and higher score indicates greater distress. A negative change from baseline indicates improvement. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52 | -37.3 ± 2.47 | -38.2 ± 2.77 | -35.0 ± 2.48 |
Assessed using the UFS-QoL questionnaire. The UFS-QoL subscale scores include items related to uterine fibroid-associated limitations/impairment in activities, revised activities, concern, energy/mood, control, self-consciousness, and sexual function. The scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Concern | 56.4 ± 2.92 | 56.4 ± 3.10 | 51.2 ± 3.10 |
| Activities | 47.8 ± 2.72 | 46.9 ± 2.82 | 45.2 ± 2.81 |
| Revised activities | 49.2 ± 2.78 | 48.0 ± 2.97 | 46.9 ± 2.85 |
| Energy/mood | 35.6 ± 2.67 | 38.6 ± 2.88 | 36.5 ± 2.79 |
| Control | 33.0 ± 2.69 | 36.4 ± 2.82 | 32.2 ± 2.91 |
| Self-conscious | 31.2 ± 3.06 | 35.4 ± 3.40 | 31.0 ± 3.14 |
| Sexual function | 22.7 ± 3.40 | 22.0 ± 3.87 | 24.1 ± 3.62 |
Assessed using the UFS-QoL Questionnaire. The UFS-QoL total score was the sum of the subscales (concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function). The raw scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From Pivotal Study Baseline In The UFS-QoL Score By Health-Related Quality of Life Total Score At Week 52 | 40.4 ± 2.50 | 41.7 ± 2.68 | 39.0 ± 2.63 |
The BPD scale has been derived from the UFS-QoL symptom severity scale. The scale consists of the following 3 symptoms proximal to uterine fibroids that are experienced by most participants: heavy bleeding during the menstrual period (Question 1), passing blood clots during the menstrual period (Question 2), and feeling tightness or pressure in the pelvic area (Question 5). Raw scores were transformed to a normalized score, with a range of possible scores from 0 to 100 (none of time, a little of time, some of the time, most of the time, and all of the time), where higher scores values are indicative of greater distress and lower scores are indicative of minimal distress. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
| score on a scale | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From Pivotal Study Baseline In The Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QoL) Bleeding And Pelvic Discomfort (BPD) Scale At Week 52 | -51.3 ± 2.66 | -51.6 ± 3.11 | -48.6 ± 2.76 |
Volume of the uterus was measured by transvaginal or transabdominal ultrasound. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
| cm^3 | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From Pivotal Study Baseline In Uterine Volume At Week 52 | -73.31 ± 14.471 | -91.67 ± 20.143 | -37.62 ± 14.541 |
Volume of the primary uterine fibroid was measured by transvaginal or transabdominal ultrasound. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
| cm^3 | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From Pivotal Study Baseline In Uterine Fibroid Volume At Week 52 | -31.84 ± 5.353 | -28.18 ± 5.523 | -17.07 ± 5.726 |
Assessed by dual-energy X-ray absorptiometry (DXA) scan at the lumbar spine (L1-L4), total hip, and femoral neck at pivotal study Baseline and at Week 52. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure.
| percentage change | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Lumbar Spine (L1-L4) | -0.804 ± 0.2803 | -2.045 ± 0.2679 | -0.775 ± 0.2781 |
| Total Hip | -0.153 ± 0.2337 | -0.842 ± 0.2308 | -0.065 ± 0.2086 |
| Femoral Neck | -0.575 ± 0.3208 | -0.513 ± 0.4503 | 0.004 ± 0.3886 |
Blood samples were collected from participants at predose for E2 measurements. These were analyzed at a central laboratory.
| pg/mL | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Change From Pivotal Study Baseline In Predose Serum E2 Concentrations At Week 52 | -21.83 ± 91.525 | -33.77 ± 106.407 | -29.99 ± 81.465 |
The EQ-5D-5L scale is a standardized instrument for use as a measure of health outcomes. Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression were each assessed on 5-point categorical scales of no problems to unable to complete specified activity, or no pain/discomfort to extreme pain/discomfort, or not anxious/depressed to extremely anxious/depressed. The change from baseline is summarized by amount of improvement (1-4 categories), amount of deterioration (1-4 categories), or no change.
| Participants | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Mobility - 4 Category deterioration | 0 | 0 | 0 |
| Mobility - 3 Category deterioration | 0 | 1 | 0 |
| Mobility - 2 Category deterioration | 2 | 0 | 0 |
| Mobility - 1 Category deterioration | 3 | 5 | 4 |
| Mobility - No change | 102 | 89 | 99 |
| Mobility - 1 Category improvement | 15 | 9 | 10 |
| Mobility - 2 Category improvement | 5 | 3 | 4 |
| Mobility - 3 Category improvement | 0 | 1 | 0 |
| Mobility - 4 Category improvement | 0 | 0 | 0 |
| Self-care - 4 Category deterioration | 0 | 0 | 0 |
| Self-care - 3 Category deterioration | 0 | 0 | 0 |
| Self-care - 2 Category deterioration | 0 | 1 | 0 |
| Self-care - 1 Category deterioration | 1 | 1 | 2 |
| Self-care - No change | 122 | 105 | 108 |
| Self care - 1 Category improvement | 3 | 0 | 5 |
| Self care - 2 Category improvement | 1 | 1 | 1 |
| Self care - 3 Category improvement | 0 | 0 | 0 |
| Self care - 4 Category improvement | 0 | 0 | 1 |
| Usual activities - 4 Category deterioration | 0 | 0 | 0 |
| Usual activities - 3 Category deterioration | 0 | 1 | 0 |
| Usual activities - 2 Category deterioration | 3 | 0 | 2 |
| Usual activities - 1 Category deterioration | 4 | 2 | 4 |
| Usual activities - No change | 91 | 71 | 73 |
| Usual activities - 1 Category improvement | 15 | 22 | 22 |
| Usual activities - 2 Category improvement | 10 | 10 | 12 |
| Usual activities - 3 Category improvement | 3 | 2 | 3 |
| Usual activities - 4 Category improvement | 1 | 0 | 1 |
| Pain/discomfort - 4 Category deterioration | 0 | 0 | 0 |
| Pain/discomfort - 3 Category deterioration | 0 | 1 | 2 |
| Pain/discomfort - 2 Category deterioration | 3 | 2 | 0 |
| Pain/discomfort - 1 Category deterioration | 17 | 8 | 10 |
| Pain/discomfort - No change | 46 | 45 | 45 |
| Pain/discomfort - 1 Category improvement | 37 | 31 | 37 |
| Pain/discomfort - 2 Category improvement | 16 | 14 | 17 |
| Pain/discomfort - 3 Category improvement | 8 | 6 | 6 |
| Pain/discomfort - 4 Category improvement | 0 | 1 | 0 |
| Anxiety/depression - 4 Category deterioration | 0 | 0 | 1 |
| Anxiety/depression - 3 Category deterioration | 0 | 0 | 0 |
| Anxiety/depression - 2 Category deterioration | 4 | 3 | 5 |
| Anxiety/depression - 1 Category deterioration | 11 | 20 | 12 |
| Anxiety/depression - No change | 79 | 53 | 69 |
| Anxiety/depression - 1 Category improvement | 24 | 25 | 17 |
| Anxiety/depression - 2 Category improvement | 8 | 7 | 11 |
| Anxiety/depression - 3 Category improvement | 0 | 0 | 1 |
| Anxiety/depression - 4 Category improvement | 1 | 0 | 1 |
Collected over Week 24 up to Week 52. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Relugolix Plus E2/NETA (Group A) | 0/163 (0%) | 1/163 (0.6%) | 22/163 (13.5%) |
| Relugolix Plus Delayed E2/NETA (Group B) | 0/149 (0%) | 5/149 (3.4%) | 12/149 (8.1%) |
| Placebo (Group C) | 0/164 (0%) | 11/164 (6.7%) | 38/164 (23.2%) |
| Event | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| AppendicitisInfections and infestations | 0/163 | 0/149 | 2/164 |
| MenorrhagiaReproductive system and breast disorders | 0/163 | 0/149 | 2/164 |
| CholecystitisHepatobiliary disorders | 0/163 | 1/149 | 0/164 |
| CholelithiasisHepatobiliary disorders | 0/163 | 1/149 | 0/164 |
| Ankle fractureInjury, poisoning and procedural complications | 0/163 | 1/149 | 0/164 |
| Forearm fractureInjury, poisoning and procedural complications | 0/163 | 1/149 | 0/164 |
| Wrist fractureInjury, poisoning and procedural complications | 0/163 | 1/149 | 0/164 |
| Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/163 | 1/149 | 0/164 |
| Uterine haemorrhageReproductive system and breast disorders | 1/163 | 0/149 | 0/164 |
| AnaemiaBlood and lymphatic system disorders | 0/163 | 0/149 | 1/164 |
| Event | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
|---|---|---|---|
| Hot flushVascular disorders | 4/163 | 0/149 | 13/164 |
| HeadacheNervous system disorders | 6/163 | 7/149 | 11/164 |
| NasopharyngitisInfections and infestations | 10/163 | 3/149 | 8/164 |
| HypertensionVascular disorders | 2/163 | 3/149 | 10/164 |
Extension Safety Population: all enrolled participants who received any amount of open-label study drug in the open-label extension study.
| Age, Continuous(years) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| Mean | 42.6 ± 5.08 | 42.1 ± 5.58 | 41.9 ± 5.43 | 42.2 ± 5.36 |
| Sex: Female, Male(Participants) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| Female | 163 | 149 | 164 | 476 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 38 | 34 | 36 | 108 |
| Not Hispanic or Latino | 122 | 113 | 126 | 361 |
| Unknown or Not Reported | 3 | 2 | 2 | 7 |
| Race/Ethnicity, Customized(Participants) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 7 | 1 | 10 |
| Asian | 0 | 3 | 0 | 3 |
| Black or African American | 69 | 81 | 88 | 238 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| White | 85 | 51 | 71 | 207 |
| Other | 2 | 3 | 2 | 7 |
| Multiple | 2 | 2 | 1 | 5 |
| Not Reported | 3 | 2 | 1 | 6 |
| Region of Enrollment(participants) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| United States | 113 | 104 | 117 | 335 |
| Belgium | 0 | 3 | 1 | 4 |
| Brazil | 4 | 6 | 2 | 12 |
| Chile | 5 | 6 | 8 | 19 |
| Czechia | 4 | 2 | 2 | 8 |
| Hungary | 6 | 4 | 7 | 17 |
| Italy | 7 | 5 | 3 | 15 |
| Poland | 14 | 14 | 19 | 47 |
| South Africa | 10 | 5 | 5 | 20 |
| Mean Menstrual Blood Loss (MBL) volume(mL) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| Mean | 248.71 ± 196.694 | 238.78 ± 155.332 | 216.01 ± 123.786 | 234.33 ± 161.753 |
| Body Mass Index(kg/m^2) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| Mean | 31.384 ± 7.0470 | 30.997 ± 6.4000 | 32.577 ± 7.4556 | 31.675 ± 7.0162 |
| Bone Mineral Density (BMD)(g/cm^2) | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total |
|---|---|---|---|---|
| Lumbar Spine (L1-L4) | 1.186 ± 0.1599 | 1.225 ± 0.1730 | 1.239 ± 0.1573 | 1.217 ± 0.1645 |
| Total Hip | 1.044 ± 0.1382 | 1.062 ± 0.1463 | 1.069 ± 0.1401 | 1.058 ± 0.1415 |
| Femoral Neck | 0.960 ± 0.1572 | 0.994 ± 0.1657 | 0.994 ± 0.1648 | 0.982 ± 0.1630 |
Showing the first 100 of 150 sites across 9 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Jan 2020, 27 months.
Results were first posted in May 2024, 4 years 3 months after primary completion. A results delay was requested in Dec 2020.
Of 17 phase 3 interventional studies under Menorrhagia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 35. This study's 27 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Relugolix