Uterine FibroidsPhase 3NCT00737282
Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
A Phase 3 study testing Proellex 25 mg and Proellex 50 mg in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 25 sites in United States.
Trial summary
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- Proellex 25 mg and Proellex 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 25 sitesUnited States
- Study dates
- Oct 2008to 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 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Speak, read and understand English or Spanish;
- Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
- One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
- Menstrual cycle lasting from 24 to 36 days;
- History of excessive menstrual bleeding;
- Negative urine pregnancy test at screening.
- Additional inclusion criteria may apply.
Who cannot join
- Six months or more (immediately prior to Screening Visit) without a menstrual period;
- Prior hysterectomy;
- Prior bilateral oophorectomy;
- Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
- Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
- Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
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- Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
- Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.
- Additional exclusion criteria may apply.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
ClinSite, LLC
Ann Arbor, Michigan, 48106
Atlanta Women's Research Inst
Atlanta, Georgia, 30342
Women Partners in Health
Austin, Texas, 78705
Impact Clinical Trials
Beverly Hills, California, 80211
Medical Network for Education and Research
Decatur, Georgia, 30033
Soapstone Center for Clinical Research
Decatur, Georgia, 30034
Clinical Trials of America
Eugene, Oregon, 97408
NECCR Falls River LLC
Fall River, Massachusetts, 02720
Female Pelvic Medicine
Grand Rapids, Michigan, 49503
University Medical Group, Dept of OB/GYN
Greenville, South Carolina, 29605
Greenville Pharmaceutical Research
Greenville, South Carolina, 29615
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205
AWC Clinical Trials LLC
Little Rock, Arkansas, 72223
York Clinical Consulting
Marrero, Louisiana, 70072
Memphis Women's Healthcare
Memphis, Tennessee, 38119
Women's Care Center, PLC Research Memphis Associates
Memphis, Tennessee, 38119
Medical Associates Inc.
Menomonee Falls, Wisconsin, 53051
Meharry Medical College
Nashville, Tennessee, 37208
Alegent Research
Omaha, Nebraska, 68124
Thomas Jefferson University - Jefferson Center for Women's Medical Specialties
Philadelphia, Pennsylvania, 19107-5127
Willowbend Health & Wellness Associates
Plano, Texas, 75093
Genesis Center for Clinical Research
San Diego, California, 92103
Physician Care Clinical Research, LLC
Sarasota, Florida, 34329
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase III, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
Read the detailed description
Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.
- Conditions
- Uterine Fibroids
- Being tested
- Proellex 25 mg, Proellex 50 mg
- 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.
Proellex 25 mgDrug
Also called Telapristone acetate
One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
Proellex 50 mgDrug
Also called Telapristone acetate
Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| 25 mg Proellex | Active comparator | Proellex 25 mg once daily Receives: Drug: Proellex 25 mg |
| Proellex 50 mg | Active comparator | 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.
To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Repros stopped study for safety and FDA put 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
- 175 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
- NCT00737282
- Sponsor's protocol ID
- ZPU-305
- Status last verified
- Aug 2014
- First submitted
- 14 Aug 2008
- 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, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
- ClinicalTrials.gov ID
- NCT00737282
- Acronym / sponsor ID
- ZPU-305
- Conditions
- Uterine Fibroids
- Keywords
- Uterine Fibroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Repros stopped study for safety and FDA put study on hold.
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 18 Aug 2008 (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.
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
Detailed description
Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25 mg Proellex | Active comparator | Drug: Proellex 25 mgProellex 25 mg once daily |
| Proellex 50 mg | Active comparator | 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)
- Speak, read and understand English or Spanish;
- Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
- One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
- Menstrual cycle lasting from 24 to 36 days;
- History of excessive menstrual bleeding;
Key exclusion criteria (9 listed)
- Six months or more (immediately prior to Screening Visit) without a menstrual period;
- Prior hysterectomy;
- Prior bilateral oophorectomy;
- Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
- Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
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 mgAlso: Telapristone acetateOne capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle | Drug | 25 mg Proellex |
| Proellex 50 mgAlso: Telapristone acetateTwo capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle | Drug | Proellex 50 mg |
Primary outcome
To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)
Time frame: 12 months
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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Life Study: Lifestyle Intervention in Fibroid Elimination
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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.
25 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 25 mg and Proellex 50 mg in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 25 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 9 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 25 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 Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle) (time frame: 12 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 21 Aug 2014.