Uterine Fibroids
Conditions
Keywords
Uterine fibroids, Fibroids
Brief summary
PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
Detailed description
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.
Interventions
DRUGProellex 25 mg
Proellex 25 mg, 1 capsule daily for 4 months
DRUGProellex 50 mg
Proellex 50 mg, 2 capsules daily for 4 months
DRUGLupron Depot
Lupron 3.75 mg monthly intramuscular injections for 4 months
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex. | 4 months |
Countries
Mexico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Proellex 25 mg Proellex 25 mg: Proellex 25 mg, 1 capsule daily for 4 months | 0 |
| Proellex 50 mg Proellex 50 mg: Proellex 50 mg, 2 capsules daily for 4 months | 0 |
| Lupron Lupron Depot: Lupron 3.75 mg monthly intramuscular injections for 4 months | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study prematurely terminated | 10 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | — Participants |
| Age, Categorical >=65 years | — Participants |
| Age, Categorical Between 18 and 65 years | — Participants |
| Region of Enrollment Mexico | — participants |
| Region of Enrollment United States | — participants |
| Sex: Female, Male Female | — Participants |
| Sex: Female, Male Male | — Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.
Time frame: 4 months
Population: Study prematurely terminated