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

Completed · Phase 2 · Has a placebo group

Conditions studied: Uterine Fibroids

In brief

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.

Key facts

Study ID

NCT02323646

Run by

Repros Therapeutics Inc.

People needed

42

Starts

2015-02-12

Expected to finish

2017-04-06

Last updated by the study team

2019-06-25

Who can join

Age: 18 and older, up to 47. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Fort Lauderdale, Florida, United States
• Study site — Sandy Springs, Georgia, United States
• Study site — Metairie, Louisiana, United States
• Study site — Saginaw, Michigan, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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