Uterine FibroidsPhase 2NCT00882258
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
A Phase 2 study testing 12.5 mg Proellex and 25 mg Proellex in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 16 sites in United States.
Trial summary
Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. 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?
- 12.5 mg Proellex and 25 mg Proellex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 16 sitesUnited States
- Study dates
- Mar 2006to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound.
- Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain
Who cannot join
- Post-menopausal women, as defined as one or more of the following:
- six months or more (immediately prior to Screening visit) without a menstrual period, or
- prior hysterectomy and/or oophorectomy
- Subjects with documented endometriosis
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Visions Clinical Research
Boynton Beach, Florida, 33437
SC Clinical Research Center
Columbia, South Carolina, 29201
Downtown Women's Health Care
Denver, Colorado, 80218
Advances in Health Inc.
Houston, Texas, 77030
Obstetrical & Gynecolgical Associates, PA (OGA)
Houston, Texas, 77054
Caring for Women
Las Vegas, Nevada, 89106
Affiliated Clinical Research, Inc.
Las Vegas, Nevada, 89128
Miami Research Associates, Women's Health Studies
Miami, Florida, 33143
Women's Health Research
Phoenix, Arizona, 85015
Arizona Wellness Centre for Women
Phoenix, Arizona, 85032
Medical Centre for Clinical Research
San Diego, California, 92108
Women's Health Care, Inc.
San Diego, California, 92123
Women's Clinical Research Centre
Seattle, Washington, 98105
Insignia Clinical Research (Tampa Bay Women's Center)
Tampa, Florida, 33607
Visions Clinical Research Tuscon
Tuscon, Arizona, 85712
About this study
Official title: A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.
Read the detailed description
Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.
- Conditions
- Uterine Fibroids
- Being tested
- 12.5 mg Proellex, 25 mg Proellex, Placebo
- 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.
12.5 mg ProellexDrug
Also called CDB-4124, Telapristone acetate
12.5 mg Proellex administered orally daily
25 mg ProellexDrug
Also called CDB-4124, Telapristone acetate
25 mg Proellex administered orally daily
PlaceboDrug
Also called Dummy
Administered orally daily
| Study group | Role | What they receive |
|---|---|---|
| 12.5 mg Proellex | Experimental | Proellex 12.5 mg daily Receives: Drug: 12.5 mg Proellex |
| 25 mg Proellex daily | Experimental | Proellex 25 mg Receives: Drug: 25 mg Proellex |
| Placebo | Placebo comparator | Placebo daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata
Measured: 91 days
Secondary outcomes (1)
To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata
Measured: 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startMar 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 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
- NCT00882258
- Sponsor's protocol ID
- ZPU-003
- Status last verified
- Jul 2014
- First submitted
- 14 Apr 2009
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
- ClinicalTrials.gov ID
- NCT00882258
- Acronym / sponsor ID
- ZPU-003
- Conditions
- Uterine Fibroids
- Keywords
- Uterine fibroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 16 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.
Detailed description
Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 12.5 mg Proellex | Experimental | Drug: 12.5 mg ProellexProellex 12.5 mg daily |
| 25 mg Proellex daily | Experimental | Drug: 25 mg ProellexProellex 25 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo daily |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound.
- Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain
Key exclusion criteria (4 listed)
- Post-menopausal women, as defined as one or more of the following:
- Subjects with documented endometriosis
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 |
|---|---|---|
| 12.5 mg ProellexAlso: CDB-4124, Telapristone acetate12.5 mg Proellex administered orally daily | Drug | 12.5 mg Proellex |
| 25 mg ProellexAlso: CDB-4124, Telapristone acetate25 mg Proellex administered orally daily | Drug | 25 mg Proellex daily |
| PlaceboAlso: DummyAdministered orally daily | Drug | Placebo |
Primary outcome
To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata
Time frame: 91 days
1 secondary outcome
To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata
Time frame: 91 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
Related trials for Uterine Fibroids
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
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.
16 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 12.5 mg Proellex and 25 mg Proellex in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 16 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 4 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: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata (time frame: 91 days). 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 8 Jul 2014.