LeiomyomaPhase 3NCT02147197

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

A Phase 3 study testing Ulipristal acetate (UPA) in people with Leiomyoma and Uterine Hemorrhage, run by Allergan at 28 sites in United States.

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: 157 participants
Where: 28 sitesUnited States
Study dates: 31 Mar 2014to 29 Mar 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

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

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 rang

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Watson Investigational Site 113
Albuquerque, New Mexico, 87109
Watson Investigational Site 103
Atlanta, Georgia, 30338
Watson Investigational Site 123
Atlanta, Georgia, 30342
Watson Investigational Site 111
Augusta, Georgia, 30912
Watson Investigational Site 131
Brownsburg, Indiana, 46112
Watson Investigational Site 101
Chattanooga, Tennessee, 37404
Watson Investigational Site 106
Clearwater, Florida, 33765
Watson Investigational Site 107
Columbus, Ohio, 43231
Watson Investigational Site 112
Denver, Colorado, 80209
Watson Investigational Site 124
Idaho Falls, Idaho, 83404
Watson Investigational Site 119
Jenkintown, Pennsylvania, 19046
Watson Investigational Site 122
Lake Worth, Florida, 33461
Watson Investigational Site 115
Lakewood, Colorado, 80228
Watson Investigational Site 126
Memphis, Tennessee, 38119
Watson Investigational Site 132
Metairie, Louisiana, 70006
Watson Investigational Site 130
Miami, Florida, 33176
Watson Investigational Site 116
Milford, Connecticut, 06460
Watson Investigational Site 108
Myrtle Beach, South Carolina, 29572
Watson Investigational Site 105
New Port Richey, Florida, 34652
Watson Investigational Site 110
Norfolk, Nebraska, 68701
Watson Investigational Site 104
Orlando, Florida, 32806
Watson Investigational Site 120
Orlando, Florida, 32806
Watson Investigational Site 121
Raleigh, North Carolina, 27607
Watson Investigational Site 102
San Diego, California, 92103
Watson Investigational Site 129
Shawnee Mission, Kansas, 66218
Watson Investigational Site 125
Tucson, Arizona, 85710
Watson Investigational Site 114
Washington D.C., District of Columbia, 20036
Watson Investigational Site 109
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official 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

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
UPA tablet
PlaceboDrug
Matching placebo tablet.

Study groups in NCT02147197
Study group	Role	What they receive
UPA 5 mg	Experimental	Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks. Receives: Drug: Ulipristal acetate (UPA); Drug: Placebo
UPA 10 mg	Experimental	UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks. Receives: Drug: Ulipristal acetate (UPA); Drug: Placebo
Placebo	Placebo comparator	Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks. Receives: 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
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.
Measured: Last 35 consecutive days on treatment in the 12-week Treatment Period
Time to Absence of Bleeding on Treatment
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.
Measured: From first dose up to the end of the 12-week Treatment Period

Secondary outcomes (2)

Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment
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.
Measured: Day 11 through the end of the 12-week Treatment Period
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
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 the end of 12-week Treatment Period

Timeline

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

31 Mar 201429 Mar 2016

First posted26 May 2014 (estimated)
Study start31 Mar 2014
Primary completion29 Mar 2016
Study completion29 Mar 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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02147197
Sponsor's protocol ID: UL1309
Status last verified: Apr 2019
First submitted: 21 May 2014
Last updated: 30 Apr 2019
Results posted: Yes, on ClinicalTrials.gov

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
Simon JA, Catherino W, Segars JH, Blakesley RE, Chan A, Sniukiene V, Al-Hendy A. Ulipristal Acetate for Treatment of Symptomatic Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Mar;131(3):431-439. doi: 10.1097/AOG.0000000000002462.
PubMed 29420395

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
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RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
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All Leiomyoma trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 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 Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
ClinicalTrials.gov ID: NCT02147197
Acronym / sponsor ID: UL1309
Conditions: Leiomyoma, Uterine Hemorrhage
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 157 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 31 Mar 2014 (actual)
Primary completion: 29 Mar 2016 (actual)
Study completion: 29 Mar 2016 (actual)
First posted: 26 May 2014 (estimated)
Results: Posted 5 Apr 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: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
UPA 5 mg	Experimental	Drug: Ulipristal acetate (UPA), Drug: PlaceboUlipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.
UPA 10 mg	Experimental	Drug: Ulipristal acetate (UPA), Drug: PlaceboUPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.
Placebo	Placebo comparator	Drug: PlaceboMatching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks.

Who may qualify

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

Key inclusion criteria (5 listed)

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

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 rang

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)UPA tablet	Drug	UPA 10 mg, UPA 5 mg
PlaceboMatching placebo tablet.	Drug	Placebo, UPA 10 mg, UPA 5 mg

Primary outcome

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.
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.

2 secondary outcomes

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
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

Results and safety

Results posted to the registry on 5 Apr 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
Placebo	56	47
UPA 5 mg	53	47
UPA 10 mg	48	39

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

Measure	Placebo n = 56	UPA 5 mg n = 53	UPA 10 mg n = 48
Value	1.8 (0.0 to 10.9)	47.2 (31.6 to 63.2)	58.3 (41.2 to 74.1)

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

Time frame: From first dose up to the end of the 12-week Treatment Period. Median (97.5% Confidence Interval). Unit: days

Measure	Placebo n = 56	UPA 5 mg n = 53	UPA 10 mg n = 48
Value	NA (NA to NA)	NA (6.0 to NA)	9.5 (5.0 to NA)

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From study drug administration until the end of the 12-week off-treatment follow-up period (Up to 24 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 56 (1.8%)	4 of 56 (7.1%)	0 of 56
UPA 5 mg	1 of 53 (1.9%)	8 of 53 (15.1%)	0 of 53
UPA 10 mg	2 of 48 (4.2%)	12 of 48 (25%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 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 29420395Simon JA, Catherino W, Segars JH, Blakesley RE, Chan A, Sniukiene V, Al-Hendy A. Ulipristal Acetate for Treatment of Symptomatic Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Mar;131(3):431-439. doi: 10.1097/AOG.0000000000002462.

Related trials for Leiomyoma

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
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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

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

28 sites in 1 country: 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 28 sites in United States.

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 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. 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. Some participants in this study may receive a placebo. 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 5 Apr 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 (time frame: Last 35 consecutive days on treatment in the 12-week Treatment Period). 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 NCT02147197, 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 30 Apr 2019.