Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-08-31

Brief Summary

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PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

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Detailed Description

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The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Conditions

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Uterine Fibroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Proellex 25 mg

Group Type EXPERIMENTAL

Proellex 25 mg

Intervention Type DRUG

Proellex 25 mg, 1 capsule daily for 4 months

Proellex 50 mg

Group Type EXPERIMENTAL

Proellex 50 mg

Intervention Type DRUG

Proellex 50 mg, 2 capsules daily for 4 months

Lupron

Lupron Depot

Group Type ACTIVE_COMPARATOR

Lupron Depot

Intervention Type DRUG

Lupron 3.75 mg monthly intramuscular injections for 4 months

Interventions

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Proellex 25 mg

Proellex 25 mg, 1 capsule daily for 4 months

Intervention Type DRUG

Proellex 50 mg

Proellex 50 mg, 2 capsules daily for 4 months

Intervention Type DRUG

Lupron Depot

Lupron 3.75 mg monthly intramuscular injections for 4 months

Intervention Type DRUG

Other Intervention Names

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Telapristone acetate Telapristone acetate Leuprolide acetate

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No