Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids

Repros Therapeutics

Status and phase: Completed; Phase 2

Conditions: Uterine Fibroids

Treatments: Drug: Placebo; Drug: Telapristone Acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02323646

ZPV-201

Details and patient eligibility

About

The primary objective of this study is to determine the safety and efficacy of two vaginal doses of Proellex® administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 47 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult females between 18 and 47 years.
• Have a history of at least 3 regular menstrual cycles in which menorrhagia is due to uterine fibroids.
• Must have uterine fibroids.
• Agreement not to attempt to become pregnant during the trial.
• Agreement to use only sanitary pads provided throughout the course of the study, tampon use is prohibited .
• Ability to complete a daily Participant diary and study procedures in compliance with the protocol.
• Have a negative pregnancy test at the Screening and Baseline visits, and subsequent study visits.
• A Body Mass Index (BMI) between 18 and 45 inclusive.
• Menstrual blood loss > 80 milliliters (mL) by alkaline hematin assay.

Exclusion criteria

• Post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy.
• Pregnant or lactating or is attempting or expecting to become pregnant during the entire study period.
• Received an investigational drug in the 30 days prior to the screening for this study.
• History of Polycystic Ovarian Syndrome (PCOS).
• Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, Dihydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to screening and during the study.
• Use of oral contraceptives in the preceding 30 days. Use of Depo-Provera® in the preceding 10 months.
• Use of Gonadotropin Releasing Hormone (GnRHas) (e.g. Lupron Depot) within 3 months of the first dose of study drug (Lupron Depot must have a wash-out period of 3 months).
• Has an Intra Uterine device (IUD) in place.
• Known or suspected carcinoma of the breast or reproductive organs.
• Recent history (within past 6 months) of alcoholism or drug abuse.
• Clinically significant abnormal findings on screening examination and laboratory assessments or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Following the baseline assessment no treatment period, matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.

Treatment:

Drug: Placebo

Telapristone Acetate 6 mg

Experimental group

Description:

Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.

Treatment:

Drug: Telapristone Acetate

Telapristone Acetate 12 mg

Experimental group

Description:

Following the baseline assessment no treatment period, telapristone acetate 12mg, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.

Treatment:

Drug: Telapristone Acetate