| May 22, 2008 |
| August 11, 2009 |
| May 2008 |
| December 2008 (final data collection date for primary outcome measure) |
| The primary outcome measure is the PK characteristics of 25 mg and 50 mg Proellex. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00683917 on ClinicalTrials.gov Archive Site |
| Transformed UFS-QoL severity score, uterine fibroid size as measured by MRI,
relapse of symptoms as recorded on subject diary cards, and
persistence of effect as measured by UFS-QoL. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids |
| 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 |
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. |
| |
| Phase II |
| Interventional |
| Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Pharmacokinetics Study |
| Uterine Fibroids |
- Drug: Proellex 25 mg
- Drug: Proellex 50 mg
- Drug: Lupron Depot
|
- Experimental: Proellex 25 mg
- Experimental: Proellex 50 mg
- Active Comparator: Lupron Depot
|
| |
| |
| Terminated |
| 30 |
| March 2010 |
| December 2008 (final data collection date for primary outcome measure) |
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:
|
| Female |
| 18 Years to 45 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Mexico |
| |
| NCT00683917 |
| Andre vanAs, MD, PhD, Repros Therapeutics, Inc. |
| ZPU-202 |
| Repros Therapeutics Inc. |
|
| Study Director: |
Andre vanAs, MD, PhD |
Repros Therapeutics Inc. |
|
|
| Repros Therapeutics Inc. |
| August 2009 |