This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

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

Sponsored by Repros Therapeutics Inc.

About this trial

Last updated 11 years ago

Study ID

ZPU-305

Status

Terminated

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18 to 48 Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 16 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status