Uterine FibroidsPhase 3NCT00785356
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 7 sites in Mexico.
Trial summary
Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily. Read more about this study
- Who is it for?
- Ages 18 to 48 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
- 8 participants
- Where
- 7 sitesMexico
- Study dates
- Oct 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 48 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
7 sites in 1 country.
7 sites in 1 country
Mexico7 sites
Comité para la Prevención de la Osteoporosis COMOP
Mexico City, Federal District, 06100
Centro Hospitalario Nuevo Sanatorio Durango
Mexico City, Federal District, 06700
Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes"
Mexico City, Federal District, 11000
Hospital Universitario "Dr. José Eleuterio González" Facultad de Medicina de la Universidad Autónoma de Nuevo León (UANL)
Monterrey, Nuevo León, 64460
MIRC (Monterrey International Research Center)
Monterrey, Nuevo León, 64460
Hospital de la Fe
San Miguel de Allende, Guanajuato, 37775
Hospital Perinatal del Estado de Mexico del ISEM
Toluca, Estado de Mexico C.P., 50120
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
Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.
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.
- 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
Also called Telapristone acetate
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
Proellex 50 mgDrug
Also called Telapristone acetate
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
PlaceboDrug
Also called Sugar pill, Dummy
Placebo, 2 capsules daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 25 mg Proellex | Experimental | Proellex 25 mg Receives: Drug: Proellex 25 mg |
| Proellex 50 mg | Experimental | Proellex 50 mg Receives: Drug: Proellex 50 mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.
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 posted5 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Repros stopped the study for safety and FDA put the study on hold for 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andre van As, MD, PhD, Study director, Repros Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785356
- Sponsor's protocol ID
- ZPU-302
- Status last verified
- Aug 2014
- First submitted
- 3 Nov 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
- NCT00785356
- Acronym / sponsor ID
- ZPU-302
- Conditions
- Uterine Fibroids, Anemia
- Keywords
- Uterine fibroids, Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Repros stopped the study for safety and FDA put the study on hold for safety.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 5 Nov 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.
Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25 mg Proellex | Experimental | Drug: Proellex 25 mgProellex 25 mg |
| Proellex 50 mg | Experimental | Drug: Proellex 50 mgProellex 50 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 48 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 mgAlso: Telapristone acetateProellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months | Drug | 25 mg Proellex |
| Proellex 50 mgAlso: Telapristone acetateProellex 50 mg, 2 - 25 mg capsules daily for 3 months | Drug | Proellex 50 mg |
| PlaceboAlso: Sugar pill, DummyPlacebo, 2 capsules daily for 3 months | Drug | Placebo |
Primary outcome
The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.
Time frame: 3 months
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 van As, MD, PhD study director
Repros Therapeutics Inc.
7 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 7 sites in Mexico.
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 7 sites in Mexico. 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?
The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months. (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.