A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas

May 15, 2019 updated by: Allergan

A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Intermittent Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
432

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S4L8
        • Watson Investigational Site 140
      • Ottawa, Ontario, Canada, K1H7W9
        • Watson Investigational Site 144
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85209
        • Watson Investigational Site 138
      • Phoenix, Arizona, United States, 85032
        • Watson Investigational Site 147
      • Scottsdale, Arizona, United States, 85251
        • Watson Investigational Site 106
      • Tucson, Arizona, United States, 85712
        • Watson Investigational Site 124
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Watson Investigational Site 155
    • California
      • Encino, California, United States, 91436
        • Watson Investigational Site 155
      • Hawaiian Gardens, California, United States, 90716
        • Watson Investigational Site 157
      • La Mesa, California, United States, 91942
        • Watson Investigational Site 134
      • San Diego, California, United States, 92111
        • Watson Investigational Site 127
      • San Diego, California, United States, 92114
        • Watson Investigational Site 151
    • Colorado
      • Denver, Colorado, United States, 80209
        • Watson Investigational Site 159
    • Florida
      • Clearwater, Florida, United States, 33759
        • Watson Investigational Site 131
      • Miramar, Florida, United States, 33027
        • Watson Investigational Site 135
      • North Miami, Florida, United States, 33161
        • Watson Investigational Site 132
      • Orlando, Florida, United States, 32806
        • Watson Investigational Site 161
      • Plantation, Florida, United States, 33324
        • Watson Investigational Site 123
      • Sarasota, Florida, United States, 34239
        • Watson Investigational Site 112
      • Wellington, Florida, United States, 33414
        • Watson Investigational Site 102
      • West Palm Beach, Florida, United States, 33409
        • Watson Investigational Site 101
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Watson Investigational Site 160
      • Sandy Springs, Georgia, United States, 30328
        • Watson Investigational Site 103
      • Savannah, Georgia, United States, 31406
        • Watson Investigational Site 117
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Watson Investigational Site 113
      • Schaumburg, Illinois, United States, 60173
        • Watson Investigational Site 119
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Watson Investigational Site 162
      • Granger, Indiana, United States, 46530
        • Watson Investigational Site 104
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Watson Investigational Site 150
      • Metairie, Louisiana, United States, 70001
        • Watson Investigational Site 130
      • New Orleans, Louisiana, United States, 70115
        • Watson Investigational Site 116
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Watson Investigational Site 108
      • Las Vegas, Nevada, United States, 89128
        • Watson Investigational Site 107
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Watson Investigational Site 111
      • Moorestown, New Jersey, United States, 08057
        • Watson Investigational Site 158
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Watson Investigational Site 115
    • New York
      • Bronx, New York, United States, 10461
        • Watson Investigational Site 155
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Watson Investigational Site 126
      • Greensboro, North Carolina, United States, 27408
        • Watson Investigational Site 128
      • New Bern, North Carolina, United States, 28562
        • Watson Investigational Site 145
      • Raleigh, North Carolina, United States, 27612
        • Watson Investigational Site 146
      • Winston-Salem, North Carolina, United States, 27103
        • Watson Investigational Site 118
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Watson Investigational Site 155
      • Cleveland, Ohio, United States, 44106
        • Watson Investigational Site 155
      • Cleveland, Ohio, United States, 44122
        • Watson Investigational Site 148
      • Englewood, Ohio, United States, 45322
        • Watson Investigational Site 139
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Watson Investigational Site 133
      • Pittsburgh, Pennsylvania, United States, 15206
        • Watson investigational site 142
      • West Reading, Pennsylvania, United States, 19611
        • Watson Investigational Site 105
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Watson Investigational Site 136
      • Charleston, South Carolina, United States, 29425
        • Watson Investigational Site 110
      • Columbia, South Carolina, United States, 29201
        • Watson Investigational Site 153
      • Greenville, South Carolina, United States, 29615
        • Watson Investigational Site 154
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Watson Investigational Site 155
    • Texas
      • Dallas, Texas, United States, 75231
        • Watson Investigational Site 122
      • Frisco, Texas, United States, 75035
        • Watson Investigational Site 114
      • Houston, Texas, United States, 77030
        • Watson Investigational Site 109
      • Houston, Texas, United States, 77054
        • Watson Investigational Site 155
      • San Antonio, Texas, United States, 78229
        • Watson Investigational Site 120
      • Webster, Texas, United States, 77598
        • Watson Investigational Site 129
    • Virginia
      • Norfolk, Virginia, United States, 23507-1627
        • Watson Investigational Site 152
      • Virginia Beach, Virginia, United States, 23456
        • Watson Investigational Site 137
    • Washington
      • Seattle, Washington, United States, 98105
        • Watson Investigational Site 121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Premenopausal women, 18-50 years, inclusive.
  • Cyclic abnormal uterine bleeding (heavy or prolonged).
  • Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in the first 8 days of menses.
  • Minimum of one discrete leiomyoma observable by transvaginal ultrasound.
  • Endometrial biopsy without evidence of malignancy or atypical or non-atypical hyperplasia.

Exclusion Criteria:

  • History of uterine surgery that would interfere with the study endpoints.
  • Known coagulation disorder including bleeding disorder or clotting disorder.
  • History of, or current uterine, cervix, ovarian, or breast cancer.
  • Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), or total bilirubin two times or greater than the upper limit of normal range.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: UPA 5 mg:Placebo
Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
Drug: Placebo
Matching placebo tablet.
Drug: Ulipristal acetate (UPA)
Ulipristal acetate (UPA) tablet.
EXPERIMENTAL: UPA 10 mg:Placebo
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2.
Drug: Placebo
Matching placebo tablet.
Drug: Ulipristal acetate (UPA)
Ulipristal acetate (UPA) tablet.
EXPERIMENTAL: UPA 5 mg:UPA 5 mg
UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
Drug: Placebo
Matching placebo tablet.
Drug: Ulipristal acetate (UPA)
Ulipristal acetate (UPA) tablet.
EXPERIMENTAL: UPA 10 mg:UPA 10 mg
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses.
Drug: Placebo
Matching placebo tablet.
Drug: Ulipristal acetate (UPA)
Ulipristal acetate (UPA) tablet.
EXPERIMENTAL: Placebo:UPA 5 mg
Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
Drug: Placebo
Matching placebo tablet.
Drug: Ulipristal acetate (UPA)
Ulipristal acetate (UPA) tablet.
EXPERIMENTAL: Placebo:UPA 10 mg
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2.
Drug: Placebo
Matching placebo tablet.
Drug: Ulipristal acetate (UPA)
Ulipristal acetate (UPA) tablet.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1
Time Frame: 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.
Last 35 consecutive days on treatment in the 12-Week Treatment Course 1
Time to Absence of Bleeding on Treatment During Treatment Course 1
Time Frame: 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.
From first dose up to the end of the 12-Week Treatment Course 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1
Time Frame: 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.
Day 11 through the end of treatment in the 12-Week Treatment Course 1
Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2
Time Frame: 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.
Last 35 consecutive days on treatment in the 12-Week Treatment Course 2
Time to Absence of Bleeding on Treatment During Treatment Course 2
Time Frame: 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.
From first dose up to the end of treatment in the 12-Week Treatment Course 2
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
Time Frame: 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.
Baseline (Day 1-4) to End of 12-Week Treatment Course 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 24, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 24, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UL1208

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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