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

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ClinicalTrials.gov Identifier: NCT02147158
Recruitment Status : Completed
First Posted : May 26, 2014
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Leiomyoma Uterine Hemorrhage Drug: Ulipristal acetate (UPA) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 29, 2014
Actual Primary Completion Date : November 24, 2016
Actual Study Completion Date : November 24, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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: Ulipristal acetate (UPA)
Ulipristal acetate (UPA) tablet.

Drug: Placebo
Matching placebo 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: Ulipristal acetate (UPA)
Ulipristal acetate (UPA) tablet.

Drug: Placebo
Matching placebo 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: Ulipristal acetate (UPA)
Ulipristal acetate (UPA) tablet.

Drug: Placebo
Matching placebo 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: Ulipristal acetate (UPA)
Ulipristal acetate (UPA) tablet.

Drug: Placebo
Matching placebo 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: Ulipristal acetate (UPA)
Ulipristal acetate (UPA) tablet.

Drug: Placebo
Matching placebo 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: Ulipristal acetate (UPA)
Ulipristal acetate (UPA) tablet.

Drug: Placebo
Matching placebo tablet.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females suffering with abnormal uterine bleeding associated with leiomyomas were treated in this study.
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147158


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02147158     History of Changes
Other Study ID Numbers: UL1208
First Posted: May 26, 2014    Key Record Dates
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Uterine Hemorrhage
Hemorrhage
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Diseases
Genital Diseases, Female
Ulipristal acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs