EndometriosisPhase 2NCT00556075
Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
A Phase 2 study testing Proellex 25 mg and Proellex 50 mg in people with Endometriosis, run by Repros Therapeutics Inc. at 17 sites in United States.
Trial summary
The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis. 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 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
- 67 participants
- Where
- 17 sitesUnited States
- Study dates
- Nov 2007to Jul 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
- Premenopausal women aged 18-48 inclusive
- Endometriosis documented by laparoscopic or surgical assessment within the past ten (10) years
- Clinical symptoms of endometriosis for at least the past three (3) months
- Endometriosis symptoms
- Must be sexually active unless sexually inactive for endometriosis-related dyspareunia
- Must have a regular or steady menstrual cycle lasting from 24 to 36 days and a detectable ovulation during the baseline period using an ovulation monitoring kit (for timing of endometrial biopsy)
- Other inclusion criteria may apply
Who cannot join
- Six (6) months or more without a menstrual period, or
- Prior hysterectomy or
- Prior bilateral oophorectomy
- Diagnosis of osteopenia
- Present history or condition that causes non-endometriosis-related dyspareunia
- Presence of excessive bleeding or menorrhagia
- Abnormal screening endometrial biopsy
- Other exclusion criteria may apply
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Physicians for Women
Cary, North Carolina, 27511
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
SC Clinical Research Center, LLC
Columbia, South Carolina, 29201
Advanced Research Associates
Corpus Christi, Texas, 78414
Medical Associates
Dubuque, Iowa, 52002
Gaffney Pharmaceutical Research
Gaffney, South Carolina, 29340
Greenville Pharma Research
Greenville, South Carolina, 29615
Altus Research
Lake Worth, Florida, 33461
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205
HWC Women's Research Center
Miamisburg, Ohio, 45342
Wake Research Associates
Raleigh, North Carolina, 27612
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 Phase II, Three-Arm, Parallel Design, Dose-Ranging Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.
- Conditions
- Endometriosis
- Being tested
- Proellex 25 mg, Placebo, Proellex 50 mg
- 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 25 mgDrug
1 capsule daily for 4 months
PlaceboDrug
1 capsule daily for 4 months
Proellex 50 mgDrug
2 capsules daily for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
| 25 mg | Experimental | Proellex 25 mg once daily Receives: Drug: Proellex 25 mg |
| 50 mg | Experimental | Proellex 50 mg once daily Receives: Drug: Proellex 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score
Measured: 4 months
Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score
Measured: 4 months
Secondary outcomes (4)
Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits
Measured: monthly
Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
Measured: days
Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
Measured: days
The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits
Measured: days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2009
- Study completionJul 2009
Why it stopped: Clinical 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 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
- NCT00556075
- Sponsor's protocol ID
- ZPE-201
- Status last verified
- Aug 2014
- First submitted
- 7 Nov 2007
- 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
- A Phase II, Three-Arm, Parallel Design, Dose-Ranging Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
- ClinicalTrials.gov ID
- NCT00556075
- Acronym / sponsor ID
- ZPE-201
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Pelvic pain, Oral progesterone blocker
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Clinical hold for safety
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Nov 2007 (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.
The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily |
| 25 mg | Experimental | Drug: Proellex 25 mgProellex 25 mg once daily |
| 50 mg | Experimental | Drug: Proellex 50 mgProellex 50 mg once daily |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Premenopausal women aged 18-48 inclusive
- Endometriosis documented by laparoscopic or surgical assessment within the past ten (10) years
- Clinical symptoms of endometriosis for at least the past three (3) months
- Endometriosis symptoms
- Must be sexually active unless sexually inactive for endometriosis-related dyspareunia
Key exclusion criteria (8 listed)
- Six (6) months or more without a menstrual period, or
- Prior hysterectomy or
- Prior bilateral oophorectomy
- Diagnosis of osteopenia
- Present history or condition that causes non-endometriosis-related dyspareunia
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 mg1 capsule daily for 4 months | Drug | 25 mg |
| Placebo1 capsule daily for 4 months | Drug | Placebo |
| Proellex 50 mg2 capsules daily for 4 months | Drug | 50 mg |
Primary outcome
Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score
Time frame: 4 months
Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score
Time frame: 4 months
4 secondary outcomes
Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits
Time frame: monthly
Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
Time frame: days
Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
Time frame: days
The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits
Time frame: days
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 vanAs, MD, PhD study director
Repros Therapeutics Inc.
17 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 25 mg and Proellex 50 mg in people with Endometriosis, run by Repros Therapeutics Inc. at 17 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 7 inclusion and 8 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 17 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 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?
Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score (time frame: 4 months). The study lists 2 primary outcomes in all. 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.