EndometriosisPhase 2NCT00958412
Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study
A Phase 2 study testing Proellex® in people with Endometriosis, run by Repros Therapeutics Inc. at 8 sites in United States.
Trial summary
ZPE-201 Extension of treatment Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Endometriosis
- 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
- 18 participants
- Where
- 8 sitesUnited States
- Study dates
- 28 Feb 2009to 31 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 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Only subjects treated in the ZPE-201 study will be allowed to enter the extension study.
- Subjects who withdrew from ZPE-201 due to lack of treatment efficacy will also be invited to participate.
Who cannot join
- All other subjects
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Physicians for Women
Cary, North Carolina, 27518
HWC Women's Research Center
Miamisburg, Ohio, 45322
Clinical Trials of Texas/Institute for Women's Health
San Antonio, Texas, 78229
Clinical Trials of Texas/Seven Oaks Women's Center
San Antonio, Texas, 78229
Medical Center for Clinical Research
San Diego, California, 92108
Compass Clinical Research
San Ramon, California, 94583
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, 85712
Comprehensive Clinical Trials
West Palm Beach, Florida, 33409
About this study
Official title: A Randomized, Double-blind Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Premenopausal Women With Symptomatic Endometriosis-extension Study
ZPE-201 Extension of treatment
Read the detailed description
This is an extension of the phase II, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of Proellex® was administered once-daily for four (4) months.
- Conditions
- Endometriosis
- Being tested
- Proellex®
- Keywords
- Endometriosis, Pelvic pain, Oral progesterone blocker
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proellex®Drug
Also called CDB-4124
one (1) 25 mg capsule daily
| Study group | Role | What they receive |
|---|---|---|
| Proellex® | Experimental | 25 mg Proellex® Receives: Drug: Proellex® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily
Number of participants who experienced 1 or more adverse event.
Measured: 6 months
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 start28 Feb 2009
- Primary completion31 Aug 2009
- Study completion31 Aug 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 EndometriosisStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Chan, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958412
- Sponsor's protocol ID
- ZPE-201 EXT
- Status last verified
- Jan 2019
- First submitted
- 11 Aug 2009
- Last updated
- 12 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Premenopausal Women With Symptomatic Endometriosis-extension Study
- ClinicalTrials.gov ID
- NCT00958412
- Acronym / sponsor ID
- ZPE-201 EXT
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Pelvic pain, Oral progesterone blocker
- 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
- 18 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2009 (actual)
- Primary completion
- 31 Aug 2009 (actual)
- Study completion
- 31 Aug 2009 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Posted 12 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ZPE-201 Extension of treatment
Detailed description
This is an extension of the phase II, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of Proellex® was administered once-daily for four (4) months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proellex® | Experimental | Drug: Proellex®25 mg Proellex® |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Only subjects treated in the ZPE-201 study will be allowed to enter the extension study.
- Subjects who withdrew from ZPE-201 due to lack of treatment efficacy will also be invited to participate.
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 |
|---|---|---|
| Proellex®Also: CDB-4124one (1) 25 mg capsule daily | Drug | Proellex® |
Primary outcome
To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily
Time frame: 6 months
Number of participants who experienced 1 or more adverse event.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Anna Chan study director
Allergan
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proellex® in people with Endometriosis, run by Repros Therapeutics Inc. at 8 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 2 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 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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 12 Feb 2019). 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 Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily (time frame: 6 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 12 Feb 2019.