Uterine FibroidsPhase 3NCT00874302
Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms
A Phase 3 study testing Proellex in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 20 sites in 2 countries.
Trial summary
Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. Read more about this study
- Who is it for?
- Ages 18 years and older, 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?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
- Subject must have uterine fibroid-associated symptoms during the-screening visit
- Subject has menstrual cycle lasting from 20 to 40 days
- Other inclusion criteria may apply
Who cannot join
- Post-menopausal women or women likely to become post-menopausal during the study
- Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating
- Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study.
- Subject who has had an acute illness within five days of study medication administration
- Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically
- Subject with an abnormal screening endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN)
- Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at screening
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States13 sites
Atlanta Women's Research Inst.
Atlanta, Georgia, 30342
Soapstone Center for Clinical Research
Decatur, Georgia, 30034
Clinical Trials of America
Eugene, Oregon, 97408
Female Pelvic Medicine
Grand Rapids, Michigan, 49503
York Clinical Consulting
Marrero, Louisiana, 70072
Women's Care Center, PLC Research Memphis Associates
Memphis, Tennessee, 38119
Meharry Medical College
Nashville, Tennessee, 37208
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, 34239
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103
Brazil7 sites
Cepeme/Cerfahc
Curitiba, Paraná, 80030-220
Vox Femina
Jundiaí, 13209-000
Brazilmed
São Paulo, São Paulo, 01416-000
Universidade Federal de São Paulo - UNIFESP
São Paulo, São Paulo, 04015-001
Hospital dos Servidores Públicos de SP
São Paulo, São Paulo, 04039-901
Hospital Heliópolis
São Paulo, São Paulo, 04230 - 000
Hospital Santa Marcelina
São Paulo, São Paulo, 08270-070
About this study
Official title: A Phase III, Open Label, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex to Assess Recurrence of Symptoms in the Treatment of Symptomatic Uterine Fibroids
Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.
Read the detailed description
Subjects with documented symptomatic uterine fibroids will be enrolled in the study. Following screening, subjects will receive daily oral study medication and will be assessed monthly for a 4 month treatment cycle. This first cycle will be followed by an off-drug interval until there is a return of significant symptomatology. Subjects will be followed for up to six (6) months post-treatment. If their lack of symptoms does not qualify them for a second cycle of treatment, they will be discharged from the study. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.
- Conditions
- Uterine Fibroids
- Being tested
- Proellex
- 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 25mg capsule taken orally once every day.
ProellexDrug
Also called Telapristone acetate
Two 25mg capsules Proellex (50mg) taken orally once every day
| Study group | Role | What they receive |
|---|---|---|
| 25 mg | Experimental | 25 mg Proellex Receives: Drug: Proellex |
| 50 mg | Experimental | 50 mg Proellex Receives: Drug: Proellex |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles
Measured: Four months each cycle
Secondary outcomes (1)
To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids
Measured: Two, 4 month cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
Why it stopped: Study terminated for safety and the 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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Repros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andre van As, MD, PhD, Study director, Repros Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874302
- Sponsor's protocol ID
- ZPU-306
- Status last verified
- Jun 2014
- First submitted
- 31 Mar 2009
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open Label, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex to Assess Recurrence of Symptoms in the Treatment of Symptomatic Uterine Fibroids
- ClinicalTrials.gov ID
- NCT00874302
- Acronym / sponsor ID
- ZPU-306
- Conditions
- Uterine Fibroids
- Keywords
- Uterine fibroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated for safety and the FDA put the study on hold for safety.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- First posted
- 2 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.
Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.
Detailed description
Subjects with documented symptomatic uterine fibroids will be enrolled in the study. Following screening, subjects will receive daily oral study medication and will be assessed monthly for a 4 month treatment cycle. This first cycle will be followed by an off-drug interval until there is a return of significant symptomatology. Subjects will be followed for up to six (6) months post-treatment. If their lack of symptoms does not qualify them for a second cycle of treatment, they will be discharged from the study. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 25 mg | Experimental | Drug: Proellex25 mg Proellex |
| 50 mg | Experimental | Drug: Proellex50 mg Proellex |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
- Subject must have uterine fibroid-associated symptoms during the-screening visit
- Subject has menstrual cycle lasting from 20 to 40 days
- Other inclusion criteria may apply
Key exclusion criteria (7 listed)
- Post-menopausal women or women likely to become post-menopausal during the study
- Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating
- Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study.
- Subject who has had an acute illness within five days of study medication administration
- Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically
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 25mg capsule taken orally once every day. | Drug | 25 mg |
| ProellexAlso: Telapristone acetateTwo 25mg capsules Proellex (50mg) taken orally once every day | Drug | 50 mg |
Primary outcome
To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles
Time frame: Four months each cycle
1 secondary outcome
To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids
Time frame: Two, 4 month cycles
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
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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 van As, MD, PhD study director
Repros Therapeutics Inc.
20 sites in 2 countries: 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 20 sites in 2 countries.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Brazil. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles (time frame: Four months each cycle). 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 27 Jun 2014.