Uterine FibroidsPhase 2NCT00683917
Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
A Phase 2 study testing Proellex 25 mg, Proellex 50 mg and Lupron Depot in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 4 sites in 2 countries.
Trial summary
PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- Proellex 25 mg, Proellex 50 mg and Lupron Depot
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2008to Aug 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive
- Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study
- Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding
- Regular or steady menstrual cycle lasting from 24 to 36 days
- Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits
- Subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug
Who cannot join
- Documented endometriosis or active pelvic inflammatory disease
- History of alcohol and/or drug abuse
- Any history or diagnosis of gynecological cancer or cervical dysplasia
- Use of an IUD
- Use of prohibited concomitant medications:
- Use of Depo-Provera must cease 10 months prior to first dose of study drug
- Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit
- Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Advances in Health, Inc.
Houston, Texas, 77030
West Houston Clinical Research Services
Houston, Texas, 77055
Physician Care Clinical Research
Sarasota, Florida, 34239
Mexico1 site
Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V. (CECYC-Pharma)
Mexico City, Federal District, 03100
About this study
Official title: A Multi-center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response
PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
Read the detailed description
The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
- Conditions
- Uterine Fibroids
- Being tested
- Proellex 25 mg, Proellex 50 mg, Lupron Depot
- Keywords
- Uterine fibroids, 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
Proellex 25 mg, 1 capsule daily for 4 months
Proellex 50 mgDrug
Also called Telapristone acetate
Proellex 50 mg, 2 capsules daily for 4 months
Lupron DepotDrug
Also called Leuprolide acetate
Lupron 3.75 mg monthly intramuscular injections for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Proellex 25 mg | Experimental | Proellex 25 mg Receives: Drug: Proellex 25 mg |
| Proellex 50 mg | Experimental | Proellex 50 mg Receives: Drug: Proellex 50 mg |
| Lupron | Active comparator | Lupron Depot Receives: Drug: Lupron Depot |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.
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 posted26 May 2008 (estimated)
- Study startMay 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 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
- NCT00683917
- Sponsor's protocol ID
- ZPU-202
- Status last verified
- Aug 2014
- First submitted
- 22 May 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 Multi-center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response
- ClinicalTrials.gov ID
- NCT00683917
- Acronym / sponsor ID
- ZPU-202
- Conditions
- Uterine Fibroids
- Keywords
- Uterine fibroids, Fibroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Repros stopped the study for safety and FDA put the study on hold for safety.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Repros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 26 May 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.
PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
Detailed description
The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Proellex 25 mg | Experimental | Drug: Proellex 25 mgProellex 25 mg |
| Proellex 50 mg | Experimental | Drug: Proellex 50 mgProellex 50 mg |
| Lupron | Active comparator | Drug: Lupron DepotLupron Depot |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive
- Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study
- Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding
- Regular or steady menstrual cycle lasting from 24 to 36 days
- Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits
Key exclusion criteria (8 listed)
- Documented endometriosis or active pelvic inflammatory disease
- History of alcohol and/or drug abuse
- Any history or diagnosis of gynecological cancer or cervical dysplasia
- Use of an IUD
- Use of prohibited concomitant medications:
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 acetateProellex 25 mg, 1 capsule daily for 4 months | Drug | Proellex 25 mg |
| Proellex 50 mgAlso: Telapristone acetateProellex 50 mg, 2 capsules daily for 4 months | Drug | Proellex 50 mg |
| Lupron DepotAlso: Leuprolide acetateLupron 3.75 mg monthly intramuscular injections for 4 months | Drug | Lupron |
Primary outcome
The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.
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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proellex 25 mg, Proellex 50 mg and Lupron Depot in people with Uterine Fibroids, run by Repros Therapeutics Inc. at 4 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 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 4 sites in United States, Mexico. 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 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 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?
The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex. (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.