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NCT Number: NCT02147197

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

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

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Key information

Conditions

Leiomyoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Watson Investigational Site 125, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ulipristal acetate (UPA)

Drug

UPA tablet

Placebo

Drug

Matching placebo tablet.

Primary outcomes

  1. Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment

    Time frame: Last 35 consecutive days on treatment in the 12-week Treatment Period

    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.

  2. Time to Absence of Bleeding on Treatment

    Time frame: From first dose up to the end of the 12-week Treatment Period

    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.

Secondary outcomes

  1. Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment

    Time frame: Day 11 through the end of the 12-week Treatment Period

    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.

  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 Period

    Time frame: Baseline (Day 1-4) to the end of 12-week 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 26, 2014
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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