Trial · NCT02147158
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas
NCT02147158, Phase 3, Completed, Allergan; results first posted 2019-06-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas. Trials, record NCT02147158. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02147158
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas
- NCT number
- NCT02147158
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 432 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Leiomyoma, Uterine Hemorrhage
- Interventions
- Ulipristal acetate (UPA), Placebo
- First posted
- 2014-05-26
- Last updated
- 2019-06-04
- Results first posted
- 2019-06-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1 | Last 35 consecutive days on treatment in the 12-Week Treatment Course 1 | Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 1. |
| Primary | Time to Absence of Bleeding on Treatment During Treatment Course 1 | From first dose up to the end of the 12-Week Treatment Course 1 | Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the first treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 1. |
| Secondary | Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1 | Day 11 through the end of treatment in the 12-Week Treatment Course 1 | Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), from Day 11 to the end of treatment in Treatment Course 1. |
| Secondary | Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2 | Last 35 consecutive days on treatment in the 12-Week Treatment Course 2 | Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 2. |
| Secondary | Time to Absence of Bleeding on Treatment During Treatment Course 2 | From first dose up to the end of treatment in the 12-Week Treatment Course 2 | Time to absence of bleeding is defined as the duration in days from first dose in treatment course 2 to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the second treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 2. |
| Secondary | Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Course 1 | Baseline (Day 1-4) to End of 12-Week Treatment Course 1 | The UFS-QOL is a uterine fibroid-specific questionnaire consisting of 37 questions developed to evaluate symptoms of uterine fibroids and their impact on health-related quality of life in women with leiomyomas. The first 8 questions comprise the Symptom Severity subscale to assess symptoms experienced by women with uterine leiomyomas, the remaining 29 questions comprise 6 subscales (Concern, Activities, Energy/mood, Control, Self-consciousness, Sexual Function) which overall deal with women's feelings and experiences regarding impact of uterine leiomyoma symptoms on her life. Each item is scored between 1 and 5, where 1=none of the time or not at all and 5=all of the time or a very great deal. A Revised Activities subscale was created to include the most relevant items pertaining to physical and social activities with a total possible score of 0 to 100. Higher Revised Activities subscale scores indicate less impact on activities. A positive change from Baseline indicates improvement. |
Source ClinicalTrials.gov
Outcomes6
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 Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1 | Last 35 consecutive days on treatment in the 12-Week Treatment Course 1 | Intent-to-Treat (ITT) Population included all randomized participants. Data was summarized as per the treatment assigned. | percentage of participants | NUMBER |
| PRIMARY | Time to Absence of Bleeding on Treatment During Treatment Course 1 | From first dose up to the end of the 12-Week Treatment Course 1 | ITT population included all randomized participants. Data was summarized per treatment assigned. | days | MEDIAN |
| SECONDARY | Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1 | Day 11 through the end of treatment in the 12-Week Treatment Course 1 | ITT population included all randomized participants. Data was summarized as per the treatment assigned. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2 | Last 35 consecutive days on treatment in the 12-Week Treatment Course 2 | Data was summarized as per the treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint. | percentage of participants | NUMBER |
| SECONDARY | Time to Absence of Bleeding on Treatment During Treatment Course 2 | From first dose up to the end of treatment in the 12-Week Treatment Course 2 | Data was summarized as per treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint. | days | MEDIAN |
| SECONDARY | Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Course 1 | Baseline (Day 1-4) to End of 12-Week Treatment Course 1 | Data was summarized as per treatment assigned and included all participants with data at both Baseline and Week 12 in Treatment Course 1. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group21
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 Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1 | Placebo | 0.0 | 97.5% Confidence Interval 0.0 to 3.8 | percentage of participants | |
| Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1 | UPA 5 mg | 42.0 | 97.5% Confidence Interval 33.3 to 51.1 | percentage of participants | |
| Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1 | UPA 10 mg | 54.8 | 97.5% Confidence Interval 45.5 to 63.8 | percentage of participants | |
| Time to Absence of Bleeding on Treatment During Treatment Course 1 | Placebo | NA | 97.5% Confidence Interval NA to NA | days | |
| Time to Absence of Bleeding on Treatment During Treatment Course 1 | UPA 5 mg | NA | 97.5% Confidence Interval 48.0 to NA | days | |
| Time to Absence of Bleeding on Treatment During Treatment Course 1 | UPA 10 mg | 36.0 | 97.5% Confidence Interval 7.0 to NA | days | |
| Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1 | Placebo | 0.0 | 97.5% Confidence Interval 0.0 to 3.8 | percentage of participants | |
| Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1 | UPA 5 mg | 34.6 | 97.5% Confidence Interval 26.3 to 43.5 | percentage of participants | |
| Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1 | UPA 10 mg | 55.4 | 97.5% Confidence Interval 46.2 to 64.4 | percentage of participants | |
| Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2 | Placebo | 8.0 | 97.5% Confidence Interval 2.6 to 17.9 | percentage of participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow72
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Course 1 | STARTED | UPA 5 mg:Placebo | 55 | |
| Treatment Course 1 | STARTED | UPA 10 mg:Placebo | 47 | |
| Treatment Course 1 | STARTED | UPA 5 mg:UPA 5 mg | 107 | |
| Treatment Course 1 | STARTED | UPA 10 mg:UPA 10 mg | 110 | |
| Treatment Course 1 | STARTED | Placebo:UPA 5 mg | 55 | |
| Treatment Course 1 | STARTED | Placebo:UPA 10 mg | 58 | |
| Treatment Course 1 | COMPLETED | UPA 5 mg:Placebo | 51 | |
| Treatment Course 1 | COMPLETED | UPA 10 mg:Placebo | 38 | |
| Treatment Course 1 | COMPLETED | UPA 5 mg:UPA 5 mg | 99 | |
| Treatment Course 1 | COMPLETED | UPA 10 mg:UPA 10 mg | 97 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 participant flowAdverse events324
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 | Nausea | Gastrointestinal disorders | Placebo (Treatment Course 1) | 5 | 116 | |
| other | Nausea | Gastrointestinal disorders | UPA 5 mg (Treatment Course 1) | 13 | 161 | |
| other | Nausea | Gastrointestinal disorders | UPA 10 mg (Treatment Course 1) | 4 | 155 | |
| other | Nausea | Gastrointestinal disorders | UPA 5 mg:Placebo (Treatment Course 2) | 0 | 40 | |
| other | Nausea | Gastrointestinal disorders | UPA 10 mg:Placebo (Treatment Course 2) | 2 | 33 | |
| other | Nausea | Gastrointestinal disorders | UPA 5 mg:UPA 5 mg (Treatment Course 2) | 3 | 84 | |
| other | Nausea | Gastrointestinal disorders | UPA 10 mg:UPA 10 mg (Treatment Course 2) | 0 | 82 | |
| other | Nausea | Gastrointestinal disorders | Placebo:UPA 5 mg (Treatment Course 2) | 0 | 42 | |
| other | Nausea | Gastrointestinal disorders | Placebo:UPA 10 mg (Treatment Course 2) | 3 | 44 | |
| other | Fatigue | General disorders | Placebo (Treatment Course 1) | 5 | 116 |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Treatment Course 1) | 0 | 116 |
| Total, all-cause mortality | UPA 5 mg (Treatment Course 1) | 0 | 161 |
| Total, all-cause mortality | UPA 10 mg (Treatment Course 1) | 0 | 155 |
| Total, all-cause mortality | UPA 5 mg:Placebo (Treatment Course 2) | 0 | 40 |
| Total, all-cause mortality | UPA 10 mg:Placebo (Treatment Course 2) | 0 | 33 |
| Total, all-cause mortality | UPA 5 mg:UPA 5 mg (Treatment Course 2) | 0 | 84 |
| Total, all-cause mortality | UPA 10 mg:UPA 10 mg (Treatment Course 2) | 0 | 82 |
| Total, all-cause mortality | Placebo:UPA 5 mg (Treatment Course 2) | 0 | 42 |
| Total, all-cause mortality | Placebo:UPA 10 mg (Treatment Course 2) | 0 | 44 |
| Total, other adverse events | Placebo (Treatment Course 1) | 18 | 116 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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