Uterine FibroidsPhase 3NCT00735553
Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids
A Phase 3 study testing Proellex in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 15 sites in United States.
Trial summary
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 15 sitesUnited States
- Study dates
- Aug 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.
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);
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Visions Clinical Research
Boynton Beach, Florida, 33472
SC Clinical Research Center
Columbia, South Carolina, 29201
Advanced Research Associates
Corpus Christi, Texas, 78414
Downtown Women's Health Care
Denver, Colorado, 80218
Advances in Health Inc.
Houston, Texas, 77030
The Woman's Hospital of Texas, Clinical Research Center
Houston, Texas, 77054
OB-GYN Associates of Mid-Florida, P.A.
Leesburg, Florida, 34748
Miami Research Associates
Miami, Florida, 33143
Women's Health Research
Phoenix, Arizona, 85015
Institute for Women's Health
San Antonio, Texas, 78229
Seven Oaks Women's Ctr.
San Antonio, Texas, 78229
Women's Health Care at Frost Steet
San Diego, California, 92123
Insignia Clinical Research
Tampa, Florida, 33613
Genova Clinical Research, Inc.
Tucson, Arizona, 85741
About this study
Official title: A Phase III, Three-arm, Parallel Design, Placebo-controlled, Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.
Read the detailed description
Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.
- Conditions
- Uterine Fibroids
- Being tested
- 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.
ProellexDrug
Also called Telapristone acetate
One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months
ProellexDrug
Also called Telapristone acetate
Two 25 mg mg capsules of Proellex® orally daily for up to four months
PlaceboDrug
Also called Sugar pill
Two placebo capsules orally daily for up to four months
| Study group | Role | What they receive |
|---|---|---|
| 25 mg Proellex | Active comparator | 25 mg oral daily dose of Proellex Receives: Drug: Proellex |
| 50 mg Proellex | Active comparator | 50 mg oral daily dose of Proellex Receives: Drug: Proellex |
| placebo | Placebo comparator | oral daily dose of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2009
- Study completionAug 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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77 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
- NCT00735553
- Sponsor's protocol ID
- ZPU-303
- Status last verified
- Aug 2014
- First submitted
- 13 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, Three-arm, Parallel Design, Placebo-controlled, Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
- ClinicalTrials.gov ID
- NCT00735553
- Acronym / sponsor ID
- ZPU-303
- Conditions
- Uterine Fibroids
- Keywords
- Uterine Fibroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Repros stopped the study for safety and FDA put the study on hold for safety.
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 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.
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.
Detailed description
Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25 mg Proellex | Active comparator | Drug: Proellex25 mg oral daily dose of Proellex |
| 50 mg Proellex | Active comparator | Drug: Proellex50 mg oral daily dose of Proellex |
| placebo | Placebo comparator | Drug: Placebooral daily dose of placebo |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 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 (8 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 |
|---|---|---|
| ProellexAlso: Telapristone acetateOne 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months | Drug | 25 mg Proellex |
| ProellexAlso: Telapristone acetateTwo 25 mg mg capsules of Proellex® orally daily for up to four months | Drug | 50 mg Proellex |
| PlaceboAlso: Sugar pillTwo placebo capsules orally daily for up to four months | Drug | placebo |
Primary outcome
To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)
Time frame: 4 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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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.
15 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 15 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 6 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 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 15 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 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 Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC) (time frame: 4 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.