Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms

Uterine Fibroids Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00874302
• Other study ID #: ZPU-306
• Status: Withdrawn
• Phase: Phase 3
• First received: March 31, 2009
• Last updated: June 26, 2014

Study information

• Verified date: June 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Proellex
One 25mg capsule taken orally once every day.
• Proellex
Two 25mg capsules Proellex (50mg) taken orally once every day

Locations

Country	Name	City	State
Brazil	Cepeme/Cerfahc	Curitiba	Paraná.
Brazil	Vox Femina	Jundiaí
Brazil	Brazilmed	São Paulo
Brazil	Hospital dos Servidores Públicos de SP	São Paulo
Brazil	Hospital Heliópolis	São Paulo
Brazil	Hospital Santa Marcelina	São Paulo
Brazil	Universidade Federal de São Paulo - UNIFESP	São Paulo
United States	Atlanta Women's Research Inst.	Atlanta	Georgia
United States	Soapstone Center for Clinical Research	Decatur	Georgia
United States	Clinical Trials of America	Eugene	Oregon
United States	Female Pelvic Medicine	Grand Rapids	Michigan
United States	York Clinical Consulting	Marrero	Louisiana
United States	Women's Care Center, PLC Research Memphis Associates	Memphis	Tennessee
United States	Meharry Medical College	Nashville	Tennessee
United States	Thomas Jefferson University - Jefferson Center for Women's Medical Specialties	Philadelphia	Pennsylvania
United States	Willowbend Health & Wellness Associates	Plano	Texas
United States	Genesis Center for Clinical Research	San Diego	California
United States	Physician Care Clinical Research, LLC	Sarasota	Florida
United States	Hawthorne Medical Research, Inc.	Winston-Salem	North Carolina
United States	Lyndhurst Gynecologic Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles		Four months each cycle	Yes
Secondary	To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids		Two, 4 month cycles	Yes