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

NCT ID: NCT02147158

Last Updated: 2019-06-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-29

Study Completion Date

2016-11-24

Brief Summary

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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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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

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Leiomyoma Uterine Hemorrhage
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Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma

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Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy

NCT03972917

Myoma Uterine Bleeding, Dysfunctional Uterine Bleeding Heavy +2 more
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Ulipristal Acetate 10 mg and Asisted Reproduction

NCT02425878

Intramural Fibroids Uterine Fibroids
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Adenomyosis and Ulipristal Acetate

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Detailed Description

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Conditions

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Leiomyoma Uterine Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Ulipristal acetate (UPA)

Intervention Type DRUG

Ulipristal acetate (UPA) tablet.

Placebo

Intervention Type DRUG

Matching placebo tablet.

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.

Group Type EXPERIMENTAL

Ulipristal acetate (UPA)

Intervention Type DRUG

Ulipristal acetate (UPA) tablet.

Placebo

Intervention Type DRUG

Matching placebo tablet.

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.

Group Type EXPERIMENTAL

Ulipristal acetate (UPA)

Intervention Type DRUG

Ulipristal acetate (UPA) tablet.

Placebo

Intervention Type DRUG

Matching placebo tablet.

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.

Group Type EXPERIMENTAL

Ulipristal acetate (UPA)

Intervention Type DRUG

Ulipristal acetate (UPA) tablet.

Placebo

Intervention Type DRUG

Matching placebo tablet.

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.

Group Type EXPERIMENTAL

Ulipristal acetate (UPA)

Intervention Type DRUG

Ulipristal acetate (UPA) tablet.

Placebo

Intervention Type DRUG

Matching placebo tablet.

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.

Group Type EXPERIMENTAL

Ulipristal acetate (UPA)

Intervention Type DRUG

Ulipristal acetate (UPA) tablet.

Placebo

Intervention Type DRUG

Matching placebo tablet.

Interventions

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Ulipristal acetate (UPA)

Ulipristal acetate (UPA) tablet.

Intervention Type DRUG

Placebo

Matching placebo tablet.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Chan

Role: STUDY_DIRECTOR

Allergan

Locations

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Watson Investigational Site 138

Mesa, Arizona, United States

Site Status

Watson Investigational Site 147

Phoenix, Arizona, United States

Site Status

Watson Investigational Site 106

Scottsdale, Arizona, United States

Site Status

Watson Investigational Site 124

Tucson, Arizona, United States

Site Status

Watson Investigational Site 155

Little Rock, Arkansas, United States

Site Status

Watson Investigational Site 155

Encino, California, United States

Site Status

Watson Investigational Site 157

Hawaiian Gardens, California, United States

Site Status

Watson Investigational Site 134

La Mesa, California, United States

Site Status

Watson Investigational Site 127

San Diego, California, United States

Site Status

Watson Investigational Site 151

San Diego, California, United States

Site Status

Watson Investigational Site 159

Denver, Colorado, United States

Site Status

Watson Investigational Site 131

Clearwater, Florida, United States

Site Status

Watson Investigational Site 135

Miramar, Florida, United States

Site Status

Watson Investigational Site 132

North Miami, Florida, United States

Site Status

Watson Investigational Site 161

Orlando, Florida, United States

Site Status

Watson Investigational Site 123

Plantation, Florida, United States

Site Status

Watson Investigational Site 112

Sarasota, Florida, United States

Site Status

Watson Investigational Site 102

Wellington, Florida, United States

Site Status

Watson Investigational Site 101

West Palm Beach, Florida, United States

Site Status

Watson Investigational Site 160

Atlanta, Georgia, United States

Site Status

Watson Investigational Site 103

Sandy Springs, Georgia, United States

Site Status

Watson Investigational Site 117

Savannah, Georgia, United States

Site Status

Watson Investigational Site 113

Champaign, Illinois, United States

Site Status

Watson Investigational Site 119

Schaumburg, Illinois, United States

Site Status

Watson Investigational Site 162

Brownsburg, Indiana, United States

Site Status

Watson Investigational Site 104

Granger, Indiana, United States

Site Status

Watson Investigational Site 150

Covington, Louisiana, United States

Site Status

Watson Investigational Site 130

Metairie, Louisiana, United States

Site Status

Watson Investigational Site 116

New Orleans, Louisiana, United States

Site Status

Watson Investigational Site 108

Las Vegas, Nevada, United States

Site Status

Watson Investigational Site 107

Las Vegas, Nevada, United States

Site Status

Watson Investigational Site 111

Lawrenceville, New Jersey, United States

Site Status

Watson Investigational Site 158

Moorestown, New Jersey, United States

Site Status

Watson Investigational Site 115

Albuquerque, New Mexico, United States

Site Status

Watson Investigational Site 155

The Bronx, New York, United States

Site Status

Watson Investigational Site 126

Durham, North Carolina, United States

Site Status

Watson Investigational Site 128

Greensboro, North Carolina, United States

Site Status

Watson Investigational Site 145

New Bern, North Carolina, United States

Site Status

Watson Investigational Site 146

Raleigh, North Carolina, United States

Site Status

Watson Investigational Site 118

Winston-Salem, North Carolina, United States

Site Status

Watson Investigational Site 155

Cincinnati, Ohio, United States

Site Status

Watson Investigational Site 155

Cleveland, Ohio, United States

Site Status

Watson Investigational Site 148

Cleveland, Ohio, United States

Site Status

Watson Investigational Site 139

Englewood, Ohio, United States

Site Status

Watson Investigational Site 133

Philadelphia, Pennsylvania, United States

Site Status

Watson investigational site 142

Pittsburgh, Pennsylvania, United States

Site Status

Watson Investigational Site 105

West Reading, Pennsylvania, United States

Site Status

Watson Investigational Site 136

Bluffton, South Carolina, United States

Site Status

Watson Investigational Site 110

Charleston, South Carolina, United States

Site Status

Watson Investigational Site 153

Columbia, South Carolina, United States

Site Status

Watson Investigational Site 154

Greenville, South Carolina, United States

Site Status

Watson Investigational Site 155

Knoxville, Tennessee, United States

Site Status

Watson Investigational Site 122

Dallas, Texas, United States

Site Status

Watson Investigational Site 114

Frisco, Texas, United States

Site Status

Watson Investigational Site 109

Houston, Texas, United States

Site Status

Watson Investigational Site 155

Houston, Texas, United States

Site Status

Watson Investigational Site 120

San Antonio, Texas, United States

Site Status

Watson Investigational Site 129

Webster, Texas, United States

Site Status

Watson Investigational Site 152

Norfolk, Virginia, United States

Site Status

Watson Investigational Site 137

Virginia Beach, Virginia, United States

Site Status

Watson Investigational Site 121

Seattle, Washington, United States

Site Status

Watson Investigational Site 140

Hamilton, Ontario, Canada

Site Status

Watson Investigational Site 144

Ottawa, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 31444600 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30969201 (View on PubMed)

Liu JH, Soper D, Lukes A, Gee P, Kimble T, Kroll R, Mallick M, Chan A, Gillard P, Harrington A, Sniukiene V, Shulman LP. Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1241-1251. doi: 10.1097/AOG.0000000000002942.

Reference Type DERIVED
PMID: 30303900 (View on PubMed)

Other Identifiers

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UL1208

Identifier Type: -

Identifier Source: org_study_id

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