Lead Sponsor

Repros Therapeutics Inc.

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

No

•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

•Documented endometriosis or active pelvic inflammatory disease
•History of alcohol and/or drug abuse
•Any history or diagnosis of gynecological cancer or cervical dysplasia
•Use of an IUD
•Use of prohibited concomitant medications:
•* Use of Depo-Provera must cease 10 months prior to first dose of study drug
•* Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit
•Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia

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