Clinical trial NCT00874302: Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Uterine Fibroids
Keywords: Uterine fibroids
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles
timeFrame: Four months each cycle
Secondary outcomes:
measure: To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids
timeFrame: Two, 4 month cycles
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: Sarasota
country: United States
facility: Physician Care Clinical Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Women's Research Inst.
state: Georgia
city: Decatur
country: United States
facility: Soapstone Center for Clinical Research
state: Georgia
city: Marrero
country: United States
facility: York Clinical Consulting
state: Louisiana
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine
state: Michigan
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Gynecologic Associates
state: North Carolina
city: Eugene
country: United States
facility: Clinical Trials of America
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University - Jefferson Center for Women's Medical Specialties
state: Pennsylvania
city: Memphis
country: United States
facility: Women's Care Center, PLC Research Memphis Associates
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Plano
country: United States
facility: Willowbend Health & Wellness Associates
state: Texas
city: Curitiba
country: Brazil
facility: Cepeme/Cerfahc
state: Paraná.
city: Jundiaí
country: Brazil
facility: Vox Femina
city: São Paulo
country: Brazil
facility: Brazilmed
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo - UNIFESP
city: São Paulo
country: Brazil
facility: Hospital dos Servidores Públicos de SP
city: São Paulo
country: Brazil
facility: Hospital Heliópolis
city: São Paulo
country: Brazil
facility: Hospital Santa Marcelina
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre van As, MD, PhD
role: STUDY_DIRECTOR
References: