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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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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