LeiomyomaPhase 3NCT02147158

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

A Phase 3 study testing Ulipristal acetate (UPA) in people with Leiomyoma and Uterine Hemorrhage, run by Allergan at 63 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Leiomyoma, Uterine Hemorrhage
What is being tested?: Ulipristal acetate (UPA)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 432 participants
Where: 63 sitesin 2 countries
Study dates: 29 Jan 2014to 24 Nov 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

63 sites in 2 countries.

Country

City, postcode or hospital

63 sites in 2 countries

United States61 sites

Watson Investigational Site 115
Albuquerque, New Mexico, 87109
Watson Investigational Site 160
Atlanta, Georgia, 30342
Watson Investigational Site 136
Bluffton, South Carolina, 29910
Watson Investigational Site 162
Brownsburg, Indiana, 46112
Watson Investigational Site 113
Champaign, Illinois, 61820
Watson Investigational Site 110
Charleston, South Carolina, 29425
Watson Investigational Site 155
Cincinnati, Ohio, 45267
Watson Investigational Site 131
Clearwater, Florida, 33759
Watson Investigational Site 155
Cleveland, Ohio, 44106
Watson Investigational Site 148
Cleveland, Ohio, 44122
Watson Investigational Site 153
Columbia, South Carolina, 29201
Watson Investigational Site 150
Covington, Louisiana, 70433
Watson Investigational Site 122
Dallas, Texas, 75231
Watson Investigational Site 159
Denver, Colorado, 80209
Watson Investigational Site 126
Durham, North Carolina, 27713
Watson Investigational Site 155
Encino, California, 91436
Watson Investigational Site 139
Englewood, Ohio, 45322
Watson Investigational Site 114
Frisco, Texas, 75035
Watson Investigational Site 104
Granger, Indiana, 46530
Watson Investigational Site 128
Greensboro, North Carolina, 27408
Watson Investigational Site 154
Greenville, South Carolina, 29615
Watson Investigational Site 157
Hawaiian Gardens, California, 90716
Watson Investigational Site 109
Houston, Texas, 77030
Watson Investigational Site 155
Houston, Texas, 77054
Watson Investigational Site 155
Knoxville, Tennessee, 37920
Watson Investigational Site 134
La Mesa, California, 91942
Watson Investigational Site 108
Las Vegas, Nevada, 89109
Watson Investigational Site 107
Las Vegas, Nevada, 89128
Watson Investigational Site 111
Lawrenceville, New Jersey, 08648
Watson Investigational Site 155
Little Rock, Arkansas, 72205
Watson Investigational Site 138
Mesa, Arizona, 85209
Watson Investigational Site 130
Metairie, Louisiana, 70001
Watson Investigational Site 135
Miramar, Florida, 33027
Watson Investigational Site 158
Moorestown, New Jersey, 08057
Watson Investigational Site 145
New Bern, North Carolina, 28562
Watson Investigational Site 116
New Orleans, Louisiana, 70115
Watson Investigational Site 152
Norfolk, Virginia, 23507-1627
Watson Investigational Site 132
North Miami, Florida, 33161
Watson Investigational Site 161
Orlando, Florida, 32806
Watson Investigational Site 133
Philadelphia, Pennsylvania, 19114
Watson Investigational Site 147
Phoenix, Arizona, 85032
Watson investigational site 142
Pittsburgh, Pennsylvania, 15206
Watson Investigational Site 123
Plantation, Florida, 33324
Watson Investigational Site 146
Raleigh, North Carolina, 27612
Watson Investigational Site 120
San Antonio, Texas, 78229
Watson Investigational Site 127
San Diego, California, 92111
Watson Investigational Site 151
San Diego, California, 92114
Watson Investigational Site 103
Sandy Springs, Georgia, 30328
Watson Investigational Site 112
Sarasota, Florida, 34239
Watson Investigational Site 117
Savannah, Georgia, 31406
Watson Investigational Site 119
Schaumburg, Illinois, 60173
Watson Investigational Site 106
Scottsdale, Arizona, 85251
Watson Investigational Site 121
Seattle, Washington, 98105
Watson Investigational Site 155
The Bronx, New York, 10461
Watson Investigational Site 124
Tucson, Arizona, 85712
Watson Investigational Site 137
Virginia Beach, Virginia, 23456
Watson Investigational Site 129
Webster, Texas, 77598
Watson Investigational Site 102
Wellington, Florida, 33414
Watson Investigational Site 101
West Palm Beach, Florida, 33409
Watson Investigational Site 105
West Reading, Pennsylvania, 19611
Watson Investigational Site 118
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada2 sites

Watson Investigational Site 140
Hamilton, Ontario, L8S4L8
Watson Investigational Site 144
Ottawa, Ontario, K1H7W9

Other trials in Canada

About this study

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

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
Being tested: Ulipristal acetate (UPA), Placebo
Medical subject headings: Leiomyoma, Uterine Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ulipristal acetate (UPA)Drug
Ulipristal acetate (UPA) tablet.
PlaceboDrug
Matching placebo tablet.

Study groups in NCT02147158
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Ulipristal acetate (UPA); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: Last 35 consecutive days on treatment in the 12-Week Treatment Course 2
Time to Absence of Bleeding on Treatment During 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.
Measured: 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
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.
Measured: Baseline (Day 1-4) to End of 12-Week Treatment Course 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jan 201424 Nov 2016

First posted26 May 2014 (estimated)
Study start29 Jan 2014
Primary completion24 Nov 2016
Study completion24 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for LeiomyomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 432 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02147158
Sponsor's protocol ID: UL1208
Status last verified: May 2019
First submitted: 10 May 2014
Last updated: 4 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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.
PubMed 31444600
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.
PubMed 30969201
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.
PubMed 30303900

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy

All Leiomyoma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02147158
Acronym / sponsor ID: UL1208
Conditions: Leiomyoma, Uterine Hemorrhage
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 432 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 29 Jan 2014 (actual)
Primary completion: 24 Nov 2016 (actual)
Study completion: 24 Nov 2016 (actual)
First posted: 26 May 2014 (estimated)
Results: Posted 4 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
UPA 5 mg:Placebo	Experimental	Drug: Ulipristal acetate (UPA), Drug: PlaceboUlipristal 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.
UPA 10 mg:Placebo	Experimental	Drug: Ulipristal acetate (UPA), Drug: PlaceboUPA 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.
UPA 5 mg:UPA 5 mg	Experimental	Drug: Ulipristal acetate (UPA), Drug: PlaceboUPA 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.
UPA 10 mg:UPA 10 mg	Experimental	Drug: Ulipristal acetate (UPA), Drug: PlaceboUPA 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.
Placebo:UPA 5 mg	Experimental	Drug: Ulipristal acetate (UPA), Drug: PlaceboMatching 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.
Placebo:UPA 10 mg	Experimental	Drug: Ulipristal acetate (UPA), Drug: PlaceboMatching 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.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ulipristal acetate (UPA)Ulipristal acetate (UPA) tablet.	Drug	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
PlaceboMatching placebo tablet.	Drug	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

Primary outcome

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.
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.

4 secondary outcomes

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
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
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
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

Results and safety

Results posted to the registry on 4 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
UPA 5 mg:Placebo	55	51
UPA 10 mg:Placebo	47	38
UPA 5 mg:UPA 5 mg	107	99
UPA 10 mg:UPA 10 mg	110	97
Placebo:UPA 5 mg	55	49
Placebo:UPA 10 mg	58	50

Primary outcome: 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. Number (97.5% Confidence Interval). Unit: percentage of participants

Measure	Placebo n = 113	UPA 5 mg n = 162	UPA 10 mg n = 157
Value	0.0 (0.0 to 3.8)	42.0 (33.3 to 51.1)	54.8 (45.5 to 63.8)

Population analysed: Intent-to-Treat (ITT) Population included all randomized participants. Data was summarized as per the treatment assigned.

Primary outcome: 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. Median (97.5% Confidence Interval). Unit: days

Measure	Placebo n = 113	UPA 5 mg n = 162	UPA 10 mg n = 157
Value	NA (NA to NA)	NA (48.0 to NA)	36.0 (7.0 to NA)

Population analysed: ITT population included all randomized participants. Data was summarized per treatment assigned.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From study drug administration in Treatment Course 1 until the end of the 12-week off-treatment follow-up period after Treatment Course 2 (Up to 42 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Treatment Course 1)	2 of 116 (1.7%)	18 of 116 (15.5%)	0 of 116
UPA 5 mg (Treatment Course 1)	3 of 161 (1.9%)	38 of 161 (23.6%)	0 of 161
UPA 10 mg (Treatment Course 1)	4 of 155 (2.6%)	46 of 155 (29.7%)	0 of 155
UPA 5 mg:Placebo (Treatment Course 2)	0 of 40 (0%)	12 of 40 (30%)	0 of 40
UPA 10 mg:Placebo (Treatment Course 2)	2 of 33 (6.1%)	11 of 33 (33.3%)	0 of 33
UPA 5 mg:UPA 5 mg (Treatment Course 2)	2 of 84 (2.4%)	20 of 84 (23.8%)	0 of 84
UPA 10 mg:UPA 10 mg (Treatment Course 2)	1 of 82 (1.2%)	8 of 82 (9.8%)	0 of 82
Placebo:UPA 5 mg (Treatment Course 2)	1 of 42 (2.4%)	7 of 42 (16.7%)	0 of 42
Placebo:UPA 10 mg (Treatment Course 2)	1 of 44 (2.3%)	9 of 44 (20.5%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31444600Coyne 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.
Derived from this study: PubMed 30969201Lukes 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.
Derived from this study: PubMed 30303900Liu 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.

Related trials for Leiomyoma

Active, not recruiting
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Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna Chan study director

Allergan

63 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ulipristal acetate (UPA) in people with Leiomyoma and Uterine Hemorrhage, run by Allergan at 63 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02147158, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.