Trial · NCT02655237
A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids
NCT02655237, Phase 3, Completed, Takeda; results first posted 2019-03-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids. Trials, record NCT02655237. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02655237
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids
- NCT number
- NCT02655237
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 281 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Uterine Fibroids
- Interventions
- Relugolix, Relugolix Placebo, Leuprorelin, Leuprorelin Placebo
- First posted
- 2016-01-13
- Last updated
- 2019-03-22
- Results first posted
- 2019-03-22
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Total PBAC Score of <10 From Week 6 to 12 | Week 6 to 12 | PBAC score was used to measure volume of menstrual blood loss. Participants used sanitary products designated by sponsor and recorded the numbers of tampons or towels used, clots and flooding in patient diary. Three diagrams used which represented a lightly, moderately stained or completely saturated pad/tampon. Following scores assigned: 1) 1, 5, or 20 points for each pad; 2) 1, 5, or 10 points for each tampon; 3) 1 or 5 points for each blood clot of \<1 cm/=1 cm/\>1 in longest diameter; 4) 5 points for each episode of flooding. The total PBAC score (sum of points) ranges from 0 to \>500. |
| Secondary | Percentage of Participants With Total PBAC Score of <10 From Week 2 to 6 | Week 2 to 6 | PBAC score was used to measure volume of menstrual blood loss. Participants used sanitary products designated by sponsor and recorded the numbers of tampons or towels used, clots and flooding in patient diary. Three diagrams used which represented a lightly, moderately stained or completely saturated pad/tampon. Following scores assigned: 1) 1, 5, or 20 points for each pad; 2) 1, 5, or 10 points for each tampon; 3) 1 or 5 points for each blood clot of \<1 cm/=1 cm/\>1 in longest diameter; 4) 5 points for each episode of flooding. The total PBAC score (sum of points) ranges from 0 to \>500. |
| Secondary | Percentage of Participants With Total PBAC Score of <10 From Week 18 to 24 | Week 18 to 24 | PBAC score was used to measure volume of menstrual blood loss. Participants used sanitary products designated by sponsor and recorded the numbers of tampons or towels used, clots and flooding in patient diary. Three diagrams used which represented a lightly, moderately stained or completely saturated pad/tampon. Following scores assigned: 1) 1, 5, or 20 points for each pad; 2) 1, 5, or 10 points for each tampon; 3) 1 or 5 points for each blood clot of \<1 cm/=1 cm/\>1 in longest diameter; 4) 5 points for each episode of flooding. The total PBAC score (sum of points) ranges from 0 to \>500. |
| Secondary | Percentage of Participants With Total PBAC Score of <10 for 6 Weeks Before the Final Dose of Study Drug | For 6 weeks before the final dose of study drug (up to Week 24) | PBAC score was used to measure volume of menstrual blood loss. Participants used sanitary products designated by sponsor and recorded the numbers of tampons or towels used, clots and flooding in patient diary. Three diagrams used which represented a lightly, moderately stained or completely saturated pad/tampon. Following scores assigned: 1) 1, 5, or 20 points for each pad; 2) 1, 5, or 10 points for each tampon; 3) 1 or 5 points for each blood clot of \<1 cm/=1 cm/\>1 in longest diameter; 4) 5 points for each episode of flooding. The total PBAC score (sum of points) ranges from 0 to \>500. |
| Secondary | Percent Change From Baseline in Myoma Volumes at Weeks 2, 4, 8, 12 and 24 | Baseline, Weeks 2, 4, 8, 12 and 24 | A transvaginal ultrasound was performed to determine myoma volumes. Only the largest myoma among those measurable at visit 1 was measured throughout the study. On the assumption that the myoma was spheroids, the myoma volumes were calculated using 3 diameters (D1, D2, and D3). D1: the longest diameter of the myoma; D2: the longest diameter of the myoma which was perpendicular to D1; D3: the diameter of the myoma which crossed the intersection of D1 and D2 (intersection "Z") and was perpendicular to D1/D2 plane. The formula used for calculation is Myoma volume= D1\*D2\*D3\*π/6. |
| Secondary | Percent Change From Baseline in Uterine Volumes at Weeks 2, 4, 8, 12 and 24 | Baseline, Weeks 2, 4, 8, 12 and 24 | A transvaginal ultrasound was performed for determination of uterine volumes. On the assumption that the uterus was spheroids, the uterine volumes were calculated using 3 diameters (D1, D2, and D3) measured as shown below: D1: the longest diameter of the uterus (unit of length: cm); D2: the longest diameter of the uterus which was perpendicular to D1 (unit of length: cm); D3: the diameter of the uterus which crossed the intersection of D1 and D2 (intersection "Z") and was perpendicular to D1/D2 plane (unit of length: cm). The formula used for calculation is Uterine volume=D1\*D2\*D3\*π/6. |
| Secondary | Change From Baseline in Hemoglobin at Weeks 4, 8, 12, 16, 20, 24 and Follow up | Baseline, Weeks 4, 8, 12, 16, 20, 24 and Follow up (up to Week 28) | Anemia-related measurements consisted of hemoglobin, which were determined at the central laboratory. |
| Secondary | Numerical Rating Scale (NRS) Score | From Week 6 to 12, from Week 2 to 6, from Week 18 to 24, and for 6 weeks before the final dose (up to Week 24) | Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. |
| Secondary | Change From Baseline in Uterine Fibroid Symptom and Quality of Life (UFS-QOL)- Symptom Severity Score at Weeks 4, 8, 12, 16, 20, 24 and Follow-up | Baseline, Weeks 4, 8, 12, 16, 20, 24 and Follow-up (up to Week 28) | UFS-QOL was a 37-item self-reporting tool for evaluating QOL in participants with uterine fibroid. It includes eight symptom-related questions and 29 HRQL questions across six subscales (concern, activities, energy/mood, control, self-consciousness, sexual function). The total symptom severity score is ranging from 0 to 100. The higher scores indicate greater severity. |
| Secondary | Change From Baseline in Uterine Fibroid Symptom and Quality of Life (UFS-QOL)- HRQL Total Scores at Weeks 4, 8, 12, 16, 20, 24 and Follow-up | Baseline, Weeks 4, 8, 12, 16, 20, 24 and Follow-up (up to Week 28) | UFS-QOL was a 37-item self-reporting tool for evaluating QOL in participants with uterine fibroid. It includes eight symptom-related questions and 29 HRQL questions across six subscales (concern, activities, energy/mood, control, self-consciousness, sexual function). The total HRQL score is ranging from 0 to 100. The higher scores indicate better QOL. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Total PBAC Score of <10 From Week 6 to 12 | Week 6 to 12 | Full analysis set (FAS) included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Total PBAC Score of <10 From Week 2 to 6 | Week 2 to 6 | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Total PBAC Score of <10 From Week 18 to 24 | Week 18 to 24 | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Total PBAC Score of <10 for 6 Weeks Before the Final Dose of Study Drug | For 6 weeks before the final dose of study drug (up to Week 24) | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Myoma Volumes at Weeks 2, 4, 8, 12 and 24 | Baseline, Weeks 2, 4, 8, 12 and 24 | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | cm^3 | MEAN |
| SECONDARY | Percent Change From Baseline in Uterine Volumes at Weeks 2, 4, 8, 12 and 24 | Baseline, Weeks 2, 4, 8, 12 and 24 | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | cm^3 | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin at Weeks 4, 8, 12, 16, 20, 24 and Follow up | Baseline, Weeks 4, 8, 12, 16, 20, 24 and Follow up (up to Week 28) | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | g/dL | MEAN |
| SECONDARY | Numerical Rating Scale (NRS) Score | From Week 6 to 12, from Week 2 to 6, from Week 18 to 24, and for 6 weeks before the final dose (up to Week 24) | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Uterine Fibroid Symptom and Quality of Life (UFS-QOL)- Symptom Severity Score at Weeks 4, 8, 12, 16, 20, 24 and Follow-up | Baseline, Weeks 4, 8, 12, 16, 20, 24 and Follow-up (up to Week 28) | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Uterine Fibroid Symptom and Quality of Life (UFS-QOL)- HRQL Total Scores at Weeks 4, 8, 12, 16, 20, 24 and Follow-up | Baseline, Weeks 4, 8, 12, 16, 20, 24 and Follow-up (up to Week 28) | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group122
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Total PBAC Score of <10 From Week 6 to 12 | Relugolix 40 mg | 82.2 | 75.773 to 88.672 | percentage of participants | |
| Percentage of Participants With Total PBAC Score of <10 From Week 6 to 12 | Leuprorelin 1.88 mg or 3.75 mg | 83.1 | 76.935 to 89.263 | percentage of participants | |
| Percentage of Participants With Total PBAC Score of <10 From Week 2 to 6 | Relugolix 40 mg | 64.2 | percentage of participants | ||
| Percentage of Participants With Total PBAC Score of <10 From Week 2 to 6 | Leuprorelin 1.88 mg or 3.75 mg | 31.7 | percentage of participants | ||
| Percentage of Participants With Total PBAC Score of <10 From Week 18 to 24 | Relugolix 40 mg | 84.1 | percentage of participants | ||
| Percentage of Participants With Total PBAC Score of <10 From Week 18 to 24 | Leuprorelin 1.88 mg or 3.75 mg | 94.7 | percentage of participants | ||
| Percentage of Participants With Total PBAC Score of <10 for 6 Weeks Before the Final Dose of Study Drug | Relugolix 40 mg | 79.0 | percentage of participants | ||
| Percentage of Participants With Total PBAC Score of <10 for 6 Weeks Before the Final Dose of Study Drug | Leuprorelin 1.88 mg or 3.75 mg | 92.3 | percentage of participants | ||
| Percent Change From Baseline in Myoma Volumes at Weeks 2, 4, 8, 12 and 24 | Relugolix 40 mg | Change at Week 2 | -18.74 | Standard Deviation 31.849 | cm^3 |
| Percent Change From Baseline in Myoma Volumes at Weeks 2, 4, 8, 12 and 24 | Leuprorelin 1.88 mg or 3.75 mg | Change at Week 2 | -6.68 | Standard Deviation 33.377 | cm^3 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Relugolix 40 mg | 139 | |
| Overall Study | STARTED | Leuprorelin 1.88 mg or 3.75 mg | 142 | |
| Overall Study | COMPLETED | Relugolix 40 mg | 122 | |
| Overall Study | COMPLETED | Leuprorelin 1.88 mg or 3.75 mg | 131 | |
| Overall Study | NOT COMPLETED | Relugolix 40 mg | 17 | |
| Overall Study | NOT COMPLETED | Leuprorelin 1.88 mg or 3.75 mg | 11 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Malaise | General disorders | Relugolix 40 mg | 8 | 138 | |
| other | Malaise | General disorders | Leuprorelin 1.88 mg or 3.75 mg | 5 | 142 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Relugolix 40 mg | 39 | 138 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Leuprorelin 1.88 mg or 3.75 mg | 46 | 142 | |
| other | Gamma-glutamyltransferase increased | Investigations | Relugolix 40 mg | 7 | 138 | |
| other | Gamma-glutamyltransferase increased | Investigations | Leuprorelin 1.88 mg or 3.75 mg | 9 | 142 | |
| other | Bone density decreased | Investigations | Relugolix 40 mg | 6 | 138 | |
| other | Bone density decreased | Investigations | Leuprorelin 1.88 mg or 3.75 mg | 8 | 142 | |
| other | Bone resorption test abnormal | Investigations | Relugolix 40 mg | 7 | 138 | |
| other | Bone resorption test abnormal | Investigations | Leuprorelin 1.88 mg or 3.75 mg | 7 | 142 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Relugolix 40 mg | 0 | 138 |
| Total, all-cause mortality | Leuprorelin 1.88 mg or 3.75 mg | 0 | 142 |
| Total, other adverse events | Relugolix 40 mg | 123 | 138 |
| Total, other adverse events | Leuprorelin 1.88 mg or 3.75 mg | 134 | 142 |
| Total, serious adverse events | Relugolix 40 mg | 0 | 138 |
| Total, serious adverse events | Leuprorelin 1.88 mg or 3.75 mg | 2 | 142 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30741797 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Relugolix 40 mg vs Leuprorelin 1.88 mg or 3.75 mg: Number of Participants With TEAE Related to Weight | Trial comparisons |
| Relugolix 40 mg vs Leuprorelin 1.88 mg or 3.75 mg: Number of Participants With TEAE Related to Standard 12-Lead ECGs | Trial comparisons |
| Relugolix 40 mg vs Leuprorelin 1.88 mg or 3.75 mg: Number of Participants Who Had One or More Treatment Emergent Adverse Event (TEAE) | Trial comparisons |
| Relugolix 40 mg vs Leuprorelin 1.88 mg or 3.75 mg: deaths from any cause | Trial comparisons |
| Relugolix 40 mg vs Leuprorelin 1.88 mg or 3.75 mg: Number of Participants With TEAE (Bone Density Decreased) Related to Bone Mineral Density | Trial comparisons |
| Relugolix 40 mg vs Leuprorelin 1.88 mg or 3.75 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02655237
GET https://conductscience.org/api/trials/v1/NCT02655237/results?page=2