Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids

Repros Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Uterine Fibroids

Treatments: Drug: Proellex 50 mg; Drug: Proellex 25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00737282

ZPU-305

Details and patient eligibility

About

The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.

Full description

Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.

Enrollment: 175 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Speak, read and understand English or Spanish;
• Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
• One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
• Menstrual cycle lasting from 24 to 36 days;
• History of excessive menstrual bleeding;
• Negative urine pregnancy test at screening.

Additional inclusion criteria may apply.

Exclusion criteria

• Six months or more (immediately prior to Screening Visit) without a menstrual period;
• Prior hysterectomy;
• Prior bilateral oophorectomy;
• Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
• Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
• Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
• Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
• Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.

Additional exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

25 mg Proellex

Active Comparator group

Description:

Proellex 25 mg once daily

Treatment:

Drug: Proellex 25 mg

Proellex 50 mg

Active Comparator group

Description:

Proellex 50 mg once daily

Treatment:

Drug: Proellex 50 mg