Uterine FibroidsPhase 3NCT01069120
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids
A Phase 3 study testing Proellex in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 4 sites in United States.
Trial summary
Safety and efficacy study of 25 and 50 mg doses of Proellex Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- Proellex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2009to 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
- Subject has a menstrual cycle lasting from 20 to 40 days.
- Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Who cannot join
- Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
- Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Visions Clinical Research
Boynton Beach, Florida, 33472
Advances in Health Inc
Houston, Texas, 77030
The Women's Hospital of Texas, Clinical Research Center
Houston, Texas, 77054
Insignia Clinical Research (Tampa Bay Women's Center)
Tampa, Florida, 33067
About this study
Official title: A Phase III Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® in the Treatment of Women Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Safety and efficacy study of 25 and 50 mg doses of Proellex
Read the detailed description
The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.
- Conditions
- Uterine Fibroids
- Being tested
- 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.
ProellexDrug
Also called CDB-4124
2, 25 mg capsules once per day
ProellexDrug
Also called CDB-4124
1, 25 mg capsule once per day
| Study group | Role | What they receive |
|---|---|---|
| 50 mg Proellex® | Active comparator | 2, 25 mg capsules Receives: Drug: Proellex |
| 25 mg Proellex® | Active comparator | 1, 25 mg capsule Receives: Drug: Proellex |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)
Measured: During two 4 month treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Repros stopped study due to safety and FDA placed study on hold
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
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andre vanAS, PhD, Md, Study director, Repros Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069120
- Sponsor's protocol ID
- ZPU-307
- Status last verified
- Aug 2014
- First submitted
- 10 Feb 2010
- 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 Phase III Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® in the Treatment of Women Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304
- ClinicalTrials.gov ID
- NCT01069120
- Acronym / sponsor ID
- ZPU-307
- Conditions
- Uterine Fibroids
- Keywords
- Uterine Fibroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Repros stopped study due to safety and FDA placed study on hold
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 17 Feb 2010 (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.
Safety and efficacy study of 25 and 50 mg doses of Proellex
Detailed description
The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 mg Proellex® | Active comparator | Drug: Proellex2, 25 mg capsules |
| 25 mg Proellex® | Active comparator | Drug: Proellex1, 25 mg capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
- Subject has a menstrual cycle lasting from 20 to 40 days.
- Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Key exclusion criteria (2 listed)
- Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
- Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
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 |
|---|---|---|
| ProellexAlso: CDB-41242, 25 mg capsules once per day | Drug | 50 mg Proellex® |
| ProellexAlso: CDB-41241, 25 mg capsule once per day | Drug | 25 mg Proellex® |
Primary outcome
To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)
Time frame: During two 4 month treatment periods
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, PhD, Md study director
Repros Therapeutics Inc.
4 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 in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 4 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 3 inclusion and 2 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 4 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. 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?
To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) (time frame: During two 4 month treatment periods). 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.