LeiomyomasPhase 3NCT01553123
Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma
A Phase 3 study testing Ulipristal Acetate and Iron in people with Leiomyomas, run by Watson Pharmaceuticals at 47 sites in United States.
Trial summary
The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Leiomyomas
- What is being tested?
- Ulipristal Acetate and Iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 47 sitesUnited States
- Study dates
- Apr 2012to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Is a pre-menopausal female, 18 - 50 years;
- Has documented leiomyoma(s);
- Has leiomyoma-related anemia;
- Has an endometrial biopsy within the screening period prior to the first dose of the test article which shows no endometrial hyperplasia;
- Is willing and able to provide written informed consent and authorization to disclose protected health information.
Who cannot join
- Has a history of uterine surgery that would interfere with the study;
- Has a condition requiring immediate or intermittent blood transfusions;
- Has a known coagulation disorder;
- Has a history of uterine, cervix, ovarian, or breast cancer;
- Has used a selective progesterone receptor modulator or a gonadotrophin releasing hormone agonist in previous 6 months;
- Has received blood transfusion within 8 weeks before the screening visit;
- Has abnormal liver functions;
- Is pregnant.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
Southeast Regional Research Group
Aiken, South Carolina, 29803
Southwest Clinical Research
Albuquerque, New Mexico, 87102
Atlanta Women's Research Institute, Inc
Atlanta, Georgia, 30342
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Visions Clinical Research
Boynton Beach, Florida, 33472
Women's Health Practice
Champaign, Illinois, 61820
South Carolina Clinical Research Center, LLC
Columbia, South Carolina, 29201
Columbus Center for Women's Health Research
Columbus, Ohio, 43213
Discovery Clinical Trials - Genesis Health Central Women's Care
Dallas, Texas, 75231
Downtown Women's Health Care
Denver, Colorado, 80218
Hutzel Womens Health Specialists
Detroit, Michigan, 48201
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713
South Bend Clinical
Granger, Indiana, 46530
Physicians for Women of Greensboro
Greensboro, North Carolina, 27408
Advances in Health Inc
Houston, Texas, 77030
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Altus Research
Lake Worth, Florida, 33461
Office of Annette Mayes, MD, PC
Las Vegas, Nevada, 89106
Office of Edmond Pack, MD
Las Vegas, Nevada, 89106
Office of R. Garn Mabey, Jr
Las Vegas, Nevada, 89128
Lawrence Obstetrics-Gynecology Clinical Research
Lawrenceville, New Jersey, 08648
Women's Clinic of Lincoln, P.C.
Lincoln, Nebraska, 68510
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, 70072
Coastal Clinical Research, Inc
Mobile, Alabama, 36608
Advanced Gynecologic Surgery Institute
Naperville, Illinois, 60540
Eastern Carolina Women's Center
New Bern, North Carolina, 28562
Women Under Study, LLC
New Orleans, Louisiana, 70115
New York Center for Women's Health Research
New York, New York, 10038
Riverside Regional Medical Center
Newport News, Virginia, 23601
Healthcare Clinical Data, Inc.
North Miami, Florida, 33161
Center for Women's Research
Palos Heights, Illinois, 60463
Women's Health Research
Phoenix, Arizona, 85015
Willowbend Health and Wellness Associates
Plano, Texas, 75093
All Women's Healthcare of West Broward
Plantation, Florida, 33324
Wake Research Associates
Raleigh, North Carolina, 27612
Benchmark Research
Sacramento, California, 95816
Clinical Trials of Texas Incorporated Laboratory
San Antonio, Texas, 78229
Sharp Rees-Stealy Medical Group
San Diego, California, 92101
Medical Center for Clinical Research
San Diego, California, 92108
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
Physician Care Clinical Research, LLC
Sarasota, Florida, 34321
Fellows Research Alliance
Savannah, Georgia, 31406
Visions Clinical Research
Tucson, Arizona, 85712
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Advanced Clinical Concepts
West Reading, Pennsylvania, 19611
PMG Research of Wilmington
Wilmington, North Carolina, 28401
Hawthorne Medical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate in Women With Anemia Associated With Uterine Leiomyomas
The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated.
Read the detailed description
This is a randomized, placebo controlled, multicenter study with parallel groups in order to evaluate the efficacy and safety of ulipristal acetate in female subjects with anemia associated with uterine leiomyomas. The objective of this study is to determine if daily ulipristal acetate with iron is more effective than iron alone.
- Conditions
- Leiomyomas
- Being tested
- Ulipristal Acetate, Iron
- Keywords
- Leiomyomas
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulipristal AcetateDrug
Also called UPA
once daily, oral
IronDrug
once daily, dried ferrous sulfate
| Study group | Role | What they receive |
|---|---|---|
| Ulipristal with iron | Experimental | Not described Receives: Drug: Ulipristal Acetate; Drug: Iron |
| Placebo | Placebo comparator | Placebo with iron Receives: Drug: Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hemoglobin levels (g/dL)
Change from baseline in hemoglobin levels (g/dL)
Measured: Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyomasStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Zobrist, MS, PhD, Study director, Watson Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553123
- Sponsor's protocol ID
- UL1104
- Status last verified
- Feb 2013
- First submitted
- 2 Mar 2012
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. 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 in Women With Anemia Associated With Uterine Leiomyomas
- ClinicalTrials.gov ID
- NCT01553123
- Acronym / sponsor ID
- UL1104
- Conditions
- Leiomyomas
- Keywords
- Leiomyomas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated.
Detailed description
This is a randomized, placebo controlled, multicenter study with parallel groups in order to evaluate the efficacy and safety of ulipristal acetate in female subjects with anemia associated with uterine leiomyomas. The objective of this study is to determine if daily ulipristal acetate with iron is more effective than iron alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulipristal with iron | Experimental | Drug: Ulipristal Acetate, Drug: Iron |
| Placebo | Placebo comparator | Drug: IronPlacebo with iron |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Is a pre-menopausal female, 18 - 50 years;
- Has documented leiomyoma(s);
- Has leiomyoma-related anemia;
- Has an endometrial biopsy within the screening period prior to the first dose of the test article which shows no endometrial hyperplasia;
- Is willing and able to provide written informed consent and authorization to disclose protected health information.
Key exclusion criteria (8 listed)
- Has a history of uterine surgery that would interfere with the study;
- Has a condition requiring immediate or intermittent blood transfusions;
- Has a known coagulation disorder;
- Has a history of uterine, cervix, ovarian, or breast cancer;
- Has used a selective progesterone receptor modulator or a gonadotrophin releasing hormone agonist in previous 6 months;
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 AcetateAlso: UPAonce daily, oral | Drug | Ulipristal with iron |
| Irononce daily, dried ferrous sulfate | Drug | Placebo, Ulipristal with iron |
Primary outcome
Change from baseline in hemoglobin levels (g/dL)
Time frame: Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3.
Change from baseline in hemoglobin levels (g/dL)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
Related trials for Leiomyomas
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
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.
Howard Zobrist, MS, PhD study director
Watson Pharmaceuticals
47 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 and Iron in people with Leiomyomas, run by Watson Pharmaceuticals at 47 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 8 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: withdrawn, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline in hemoglobin levels (g/dL) (time frame: Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2013.