Uterine FibroidsPhase 2NCT00958893
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext
A Phase 2 study testing 25 mg Proellex in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 1 site in United States.
Trial summary
An open label, extension study for subjects completing the ZPU-003 Ext 1 study. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- 25 mg Proellex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Aug 2009
- Phase
- Phase 2
- 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
- Four subjects at one site whom have completed ZPU 003 Ext 1 study
Who cannot join
- All other subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Extension Study Evaluating Safety and Efficacy of Proellex® In Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext
An open label, extension study for subjects completing the ZPU-003 Ext 1 study.
Read the detailed description
This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cycles separated by off drug intervals.
- Conditions
- Uterine Fibroids
- Being tested
- 25 mg Proellex
- Keywords
- Uterine fibroids
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 mg ProellexDrug
Also called CDB-4124, Proellex
one 25 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| 25 mg Proellex | Experimental | 25 mg Proellex daily Receives: Drug: 25 mg Proellex |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals.
Measured: three 4 month cycles separated by off-drug intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startJun 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 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
- NCT00958893
- Sponsor's protocol ID
- ZPU-003 Extension 2
- Status last verified
- Aug 2014
- First submitted
- 11 Aug 2009
- Last updated
- 25 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 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study Evaluating Safety and Efficacy of Proellex® In Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext
- ClinicalTrials.gov ID
- NCT00958893
- Acronym / sponsor ID
- ZPU-003 Extension 2
- Conditions
- Uterine Fibroids
- Keywords
- Uterine fibroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Repros stopped the study for safety and FDA put the study on hold for safety.
- Enrolment
- 4 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
- 13 Aug 2009 (estimated)
- Results
- Posted 25 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label, extension study for subjects completing the ZPU-003 Ext 1 study.
Detailed description
This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cycles separated by off drug intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 25 mg Proellex | Experimental | Drug: 25 mg Proellex25 mg Proellex daily |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Four subjects at one site whom have completed ZPU 003 Ext 1 study
Key exclusion criteria (1 listed)
- All other subjects
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 |
|---|---|---|
| 25 mg ProellexAlso: CDB-4124, Proellexone 25 mg capsules | Drug | 25 mg Proellex |
Primary outcome
To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals.
Time frame: three 4 month cycles separated by off-drug intervals
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 25 mg Proellex in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 1 site 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 1 inclusion and 1 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 25 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 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 25 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?
To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals. (time frame: three 4 month cycles separated by off-drug intervals). 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 25 Aug 2014.