A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the 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: Completed
• Conditions: Uterine Hemorrhage; Leiomyoma
• Intervention / Treatment: Drug: Placebo; Drug: Ulipristal acetate (UPA)

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Watson Investigational Site 125
  • California
    • San Diego, California, United States, 92103
      • Watson Investigational Site 102
  • Colorado
    • Denver, Colorado, United States, 80209
      • Watson Investigational Site 112
    • Lakewood, Colorado, United States, 80228
      • Watson Investigational Site 115
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Watson Investigational Site 116
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • Watson Investigational Site 114
  • Florida
    • Clearwater, Florida, United States, 33765
      • Watson Investigational Site 106
    • Lake Worth, Florida, United States, 33461
      • Watson Investigational Site 122
    • Miami, Florida, United States, 33176
      • Watson Investigational Site 130
    • New Port Richey, Florida, United States, 34652
      • Watson Investigational Site 105
    • Orlando, Florida, United States, 32806
      • Watson Investigational Site 104
    • Orlando, Florida, United States, 32806
      • Watson Investigational Site 120
  • Georgia
    • Atlanta, Georgia, United States, 30338
      • Watson Investigational Site 103
    • Atlanta, Georgia, United States, 30342
      • Watson Investigational Site 123
    • Augusta, Georgia, United States, 30912
      • Watson Investigational Site 111
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Watson Investigational Site 124
  • Indiana
    • Brownsburg, Indiana, United States, 46112
      • Watson Investigational Site 131
  • Kansas
    • Shawnee Mission, Kansas, United States, 66218
      • Watson Investigational Site 129
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Watson Investigational Site 132
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Watson Investigational Site 110
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Watson Investigational Site 113
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Watson Investigational Site 121
    • Winston-Salem, North Carolina, United States, 27103
      • Watson Investigational Site 109
  • Ohio
    • Columbus, Ohio, United States, 43231
      • Watson Investigational Site 107
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • Watson Investigational Site 119
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Watson Investigational Site 108
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Watson Investigational Site 101
    • Memphis, Tennessee, United States, 38119
      • Watson Investigational Site 126

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pre-menopausal 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 rang

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: UPA 5 mg; Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.	Drug: Placebo; Matching placebo tablet.; Drug: Ulipristal acetate (UPA); UPA tablet
EXPERIMENTAL: UPA 10 mg; UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.	Drug: Placebo; Matching placebo tablet.; Drug: Ulipristal acetate (UPA); UPA tablet
PLACEBO_COMPARATOR: Placebo; Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks.	Drug: Placebo; Matching placebo tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment	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 the 12-week Treatment Period.	Last 35 consecutive days on treatment in the 12-week Treatment Period
Time to Absence of Bleeding on Treatment	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 on treatment. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose on treatment in the 12-week Treatment Period.	From first dose up to the end of the 12-week Treatment Period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment	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), starting from Day 11 through the end of the 12-week Treatment Period.	Day 11 through the end of the 12-week Treatment Period
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 Period	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 the end of 12-week Treatment Period

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• Coyne KS, Harrington A, Currie BM, Chen J, Gillard P, Spies JB. Psychometric validation of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL). J Patient Rep Outcomes. 2019 Aug 23;3(1):57. doi: 10.1186/s41687-019-0146-x.
• Lukes AS, Soper D, Harrington A, Sniukiene V, Mo Y, Gillard P, Shulman L. Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):869-878. doi: 10.1097/AOG.0000000000003211.
• Simon JA, Catherino W, Segars JH, Blakesley RE, Chan A, Sniukiene V, Al-Hendy A. Ulipristal Acetate for Treatment of Symptomatic Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Mar;131(3):431-439. doi: 10.1097/AOG.0000000000002462.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2014
• Primary Completion (ACTUAL): March 29, 2016
• Study Completion (ACTUAL): March 29, 2016

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (ESTIMATE): May 26, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Hemorrhage; Leiomyoma; Myofibroma; Uterine Hemorrhage; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Ulipristal acetate
• Other Study ID Numbers: UL1309