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

NCT02147158 | Completed Phase 3 Results FDA Drug

• 1 other identifier: UL1208
• Study Type: interventional
• Target: 432
• Locations: 2 countries
• Sites: 63

Brief Summary

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

Conditions

Leiomyoma; Uterine Hemorrhage

Outcome Measures

Primary Outcomes (2)

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

  Last 35 consecutive days on treatment in the 12-Week Treatment Course 1

• Time to Absence of Bleeding on Treatment During 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.

  From first dose up to the end of the 12-Week Treatment Course 1

Secondary Outcomes (4)

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

  Day 11 through the end of treatment in the 12-Week Treatment Course 1

• Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2

  Last 35 consecutive days on treatment in the 12-Week Treatment Course 2

• Time to Absence of Bleeding on Treatment During Treatment Course 2

  From first dose up to the end of treatment in the 12-Week Treatment Course 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 Course 1

  Baseline (Day 1-4) to End of 12-Week Treatment Course 1

Study Arms (6)

UPA 5 mg:Placebo

EXPERIMENTAL

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); Drug: Placebo

UPA 10 mg:Placebo

EXPERIMENTAL

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); Drug: Placebo

UPA 5 mg:UPA 5 mg

EXPERIMENTAL

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); Drug: Placebo

UPA 10 mg:UPA 10 mg

EXPERIMENTAL

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); Drug: Placebo

Placebo:UPA 5 mg

EXPERIMENTAL

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); Drug: Placebo

Placebo:UPA 10 mg

EXPERIMENTAL

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); Drug: Placebo

Interventions

Ulipristal acetate (UPA) DRUG

Ulipristal acetate (UPA) tablet.

Placebo:UPA 10 mg; Placebo:UPA 5 mg; UPA 10 mg:Placebo; UPA 10 mg:UPA 10 mg; UPA 5 mg:Placebo; UPA 5 mg:UPA 5 mg

Placebo DRUG

Matching placebo tablet.

Placebo:UPA 10 mg; Placebo:UPA 5 mg; UPA 10 mg:Placebo; UPA 10 mg:UPA 10 mg; UPA 5 mg:Placebo; UPA 5 mg:UPA 5 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Females suffering with abnormal uterine bleeding associated with leiomyomas were treated in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (63)

Watson Investigational Site 138

Mesa, Arizona, 85209, United States

Location

Watson Investigational Site 147

Phoenix, Arizona, 85032, United States

Location

Watson Investigational Site 106

Scottsdale, Arizona, 85251, United States

Location

Watson Investigational Site 124

Tucson, Arizona, 85712, United States

Location

Watson Investigational Site 155

Little Rock, Arkansas, 72205, United States

Location

Watson Investigational Site 155

Encino, California, 91436, United States

Location

Watson Investigational Site 157

Hawaiian Gardens, California, 90716, United States

Location

Watson Investigational Site 134

La Mesa, California, 91942, United States

Location

Watson Investigational Site 127

San Diego, California, 92111, United States

Location

Watson Investigational Site 151

San Diego, California, 92114, United States

Location

Watson Investigational Site 159

Denver, Colorado, 80209, United States

Location

Watson Investigational Site 131

Clearwater, Florida, 33759, United States

Location

Watson Investigational Site 135

Miramar, Florida, 33027, United States

Location

Watson Investigational Site 132

North Miami, Florida, 33161, United States

Location

Watson Investigational Site 161

Orlando, Florida, 32806, United States

Location

Watson Investigational Site 123

Plantation, Florida, 33324, United States

Location

Watson Investigational Site 112

Sarasota, Florida, 34239, United States

Location

Watson Investigational Site 102

Wellington, Florida, 33414, United States

Location

Watson Investigational Site 101

West Palm Beach, Florida, 33409, United States

Location

Watson Investigational Site 160

Atlanta, Georgia, 30342, United States

Location

Watson Investigational Site 103

Sandy Springs, Georgia, 30328, United States

Location

Watson Investigational Site 117

Savannah, Georgia, 31406, United States

Location

Watson Investigational Site 113

Champaign, Illinois, 61820, United States

Location

Watson Investigational Site 119

Schaumburg, Illinois, 60173, United States

Location

Watson Investigational Site 162

Brownsburg, Indiana, 46112, United States

Location

Watson Investigational Site 104

Granger, Indiana, 46530, United States

Location

Watson Investigational Site 150

Covington, Louisiana, 70433, United States

Location

Watson Investigational Site 130

Metairie, Louisiana, 70001, United States

Location

Watson Investigational Site 116

New Orleans, Louisiana, 70115, United States

Location

Watson Investigational Site 108

Las Vegas, Nevada, 89109, United States

Location

Watson Investigational Site 107

Las Vegas, Nevada, 89128, United States

Location

Watson Investigational Site 111

Lawrenceville, New Jersey, 08648, United States

Location

Watson Investigational Site 158

Moorestown, New Jersey, 08057, United States

Location

Watson Investigational Site 115

Albuquerque, New Mexico, 87109, United States

Location

Watson Investigational Site 155

The Bronx, New York, 10461, United States

Location

Watson Investigational Site 126

Durham, North Carolina, 27713, United States

Location

Watson Investigational Site 128

Greensboro, North Carolina, 27408, United States

Location

Watson Investigational Site 145

New Bern, North Carolina, 28562, United States

Location

Watson Investigational Site 146

Raleigh, North Carolina, 27612, United States

Location

Watson Investigational Site 118

Winston-Salem, North Carolina, 27103, United States

Location

Watson Investigational Site 155

Cincinnati, Ohio, 45267, United States

Location

Watson Investigational Site 155

Cleveland, Ohio, 44106, United States

Location

Watson Investigational Site 148

Cleveland, Ohio, 44122, United States

Location

Watson Investigational Site 139

Englewood, Ohio, 45322, United States

Location

Watson Investigational Site 133

Philadelphia, Pennsylvania, 19114, United States

Location

Watson investigational site 142

Pittsburgh, Pennsylvania, 15206, United States

Location

Watson Investigational Site 105

West Reading, Pennsylvania, 19611, United States

Location

Watson Investigational Site 136

Bluffton, South Carolina, 29910, United States

Location

Watson Investigational Site 110

Charleston, South Carolina, 29425, United States

Location

Watson Investigational Site 153

Columbia, South Carolina, 29201, United States

Location

Watson Investigational Site 154

Greenville, South Carolina, 29615, United States

Location

Watson Investigational Site 155

Knoxville, Tennessee, 37920, United States

Location

Watson Investigational Site 122

Dallas, Texas, 75231, United States

Location

Watson Investigational Site 114

Frisco, Texas, 75035, United States

Location

Watson Investigational Site 109

Houston, Texas, 77030, United States

Location

Watson Investigational Site 155

Houston, Texas, 77054, United States

Location

Watson Investigational Site 120

San Antonio, Texas, 78229, United States

Location

Watson Investigational Site 129

Webster, Texas, 77598, United States

Location

Watson Investigational Site 152

Norfolk, Virginia, 23507-1627, United States

Location

Watson Investigational Site 137

Virginia Beach, Virginia, 23456, United States

Location

Watson Investigational Site 121

Seattle, Washington, 98105, United States

Location

Watson Investigational Site 140

Hamilton, Ontario, L8S4L8, Canada

Location

Watson Investigational Site 144

Ottawa, Ontario, K1H7W9, Canada

Location

Related Publications (3)

• 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.

  PMID: 31444600 DERIVED

• 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.

  PMID: 30969201 DERIVED

• 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.

  PMID: 30303900 DERIVED

MeSH Terms

Conditions

Leiomyoma; Uterine Hemorrhage

Interventions

ulipristal acetate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Anna Chan

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2014
• First Posted: May 26, 2014
• Study Start: January 29, 2014
• Primary Completion: November 24, 2016
• Study Completion: November 24, 2016
• Last Updated: June 4, 2019
• Results First Posted: June 4, 2019

Record last verified: 2019-05

Locations

CA (2); US (61)