Uterine FibroidsPhase 3NCT00702702
Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids
A Phase 3 study testing Proellex 25 mg and Proellex 50 mg in people with Uterine Fibroids and Anemia, run by Repros Therapeutics Inc. at 30 sites in United States.
Trial summary
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Uterine Fibroids, Anemia
- What is being tested?
- Proellex 25 mg and Proellex 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 30 sitesUnited States
- Study dates
- Jun 2008to Aug 2009
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
- Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
- Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
- Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits
Who cannot join
- Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:
- Six months or more (immediately prior to Screening Visit) without a menstrual period, or
- Prior hysterectomy, or
- Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);
- Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
- Documented endometriosis or active pelvic inflammatory disease (PID);
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- Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
- Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;
- Use of prohibited concomitant medications:
- Depo-Provera use must cease ten months prior to first dose of study drug, or
- GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
- Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Visions Clinical Research
Boynton Beach, Florida, 33472
Central Brooklyn Medical Group (eCast)
Brooklyn, New York, 11205
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404
Rapid Medical Research, Inc.(Elite)
Cleveland, Ohio, 44122
Phoenix Women's Center (eCast)
College Park, Georgia, 30349
SC Clinical Research Center
Columbia, South Carolina, 29201
Advanced Research Associates
Corpus Christi, Texas, 78414
Clinical Trials Select (ecast)
Decatur, Georgia, 30030
Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)
Decatur, Georgia, 30035
Medical Network for Education and Research
Decatur, Georgia, 30333
Downtown Women's Health Care
Denver, Colorado, 80218
HWC Women's Research Center
Englewood, Ohio, 45322
Advances in Health Inc.
Houston, Texas, 77030
The Women's Hospital of Texas, Clinical Research Center
Houston, Texas, 77054
Centex Research
Houston, Texas, 77079
OB-GYN Associates of Mid-Florida, P.A.
Leesburg, Florida, 34748
Impact Clinical Trials
Los Angeles, California, 90057
National Institute of Clinical Research
Los Angeles, California, 90057
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, 40291
Segal Institute for Clinical Research
Miami, Florida, 33161
Phoenix OB-GYN Associates, LLC
Moorestown, New Jersey, 08057
Smith & Hackney
Morrow, Georgia, 30260
Women's Health Research
Phoenix, Arizona, 85015
Institute for Women's Health
San Antonio, Texas, 78229
Seven Oaks Women's Center
San Antonio, Texas, 78229
Clinical Trials Select (ecast)
Silver Spring, Maryland, 20903
Insignia Clinical Research (Tampa Bay Women's Center)
Tampa, Florida, 33607
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
About this study
Official title: A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Requiring Hysterectomy
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.
Read the detailed description
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.
Study was terminated by clinical hold.
- Conditions
- Uterine Fibroids, Anemia
- Being tested
- Proellex 25 mg, Proellex 50 mg, Placebo
- Keywords
- Uterine fibroids, Anemia
- Medical subject headings
- Leiomyoma, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proellex 25 mgDrug
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
Proellex 50 mgDrug
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
PlaceboDrug
Placebo, 2 capsules daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| A 25 mg | Experimental | Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months Receives: Drug: Proellex 25 mg |
| B 50 mg | Experimental | Proellex 50 mg, 2 - 25 mg capsules daily for 3 months Receives: Drug: Proellex 50 mg |
| C Placebo | Placebo comparator | Placebo, 2 capsules daily for 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin vs Placebo
Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Repros stopped study for safety and FDA put study on hold because of safety.
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.
- Other trials for Uterine FibroidsStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andre vanAs, MD, PhD, Study director, Repros Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702702
- Sponsor's protocol ID
- ZPU-301
- Status last verified
- Aug 2014
- First submitted
- 18 Jun 2008
- Last updated
- 21 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Requiring Hysterectomy
- ClinicalTrials.gov ID
- NCT00702702
- Acronym / sponsor ID
- ZPU-301
- Conditions
- Uterine Fibroids, Anemia
- Keywords
- Uterine fibroids, Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Repros stopped study for safety and FDA put study on hold because of safety.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Posted 21 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.
Detailed description
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.
Study was terminated by clinical hold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A 25 mg | Experimental | Drug: Proellex 25 mgProellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months |
| B 50 mg | Experimental | Drug: Proellex 50 mgProellex 50 mg, 2 - 25 mg capsules daily for 3 months |
| C Placebo | Placebo comparator | Drug: PlaceboPlacebo, 2 capsules daily for 3 months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
- Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
- Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
- Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits
Key exclusion criteria (12 listed)
- Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:
- Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
- Documented endometriosis or active pelvic inflammatory disease (PID);
- Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
- Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;
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 |
|---|---|---|
| Proellex 25 mgProellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months | Drug | A 25 mg |
| Proellex 50 mgProellex 50 mg, 2 - 25 mg capsules daily for 3 months | Drug | B 50 mg |
| PlaceboPlacebo, 2 capsules daily for 3 months | Drug | C Placebo |
Primary outcome
Change in Hemoglobin vs Placebo
Time frame: 3 months
Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andre vanAs, MD, PhD study director
Repros Therapeutics Inc.
30 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 Proellex 25 mg and Proellex 50 mg in people with Uterine Fibroids and Anemia, run by Repros Therapeutics Inc. at 30 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 21 Aug 2014). 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?
Change in Hemoglobin vs Placebo (time frame: 3 months). 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 21 Aug 2014.