Primary outcome· 4 months
The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.
| Group | Value |
|---|---|
| Proellex 25 mg | not posted |
| Proellex 50 mg | not posted |
| Lupron | not posted |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataPharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
NCTNCT00683917 (opens ClinicalTrials.gov in a new tab)Other idZPU-202
This trial was stopped early.
Reason given at the registry: Repros stopped the study for safety and FDA put the study on hold for safety.
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 2
- Enrollment
- 10 participants (actual)
- Sponsor
- Repros Therapeutics Inc. · Industry
- Design
- Randomized · Single masking
- Countries
2 countries
United States, Mexico
- Start
- May 2008
- Primary completion
- Aug 2009
- Completion
- Aug 2009
- First posted
- 26 May 2008 (estimated)
- Last update posted
- 21 Aug 2014 (estimated)
- Conditions
- Uterine Fibroids
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200820092010
- Ph 2Terminated
Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
NCT00683917May 2008 to Aug 2009
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
Interventions
- Proellex 25 mgDrug
- Proellex 50 mgDrug
- Lupron DepotDrug
Arms3
Experimental
Proellex 25 mg
Proellex 25 mg
Experimental
Proellex 50 mg
Proellex 50 mg
Active comparator
Lupron
Lupron Depot
Primary outcomes1
Outcomes the sponsor listed as primary.
The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.
Time frame · 4 months
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Proellex 25 mgProellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months | – | 0 / 0 | 0 / 0 |
| Proellex 50 mgProellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months | – | 0 / 0 | 0 / 0 |
| LupronLupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months | – | 0 / 0 | 0 / 0 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 45 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
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