Uterine Fibroids
Conditions
Keywords
Uterine Fibroids
Brief summary
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.
Detailed description
Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.
Interventions
DRUGProellex
One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months
DRUGPlacebo
Two placebo capsules orally daily for up to four months
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No
Inclusion criteria
* Speak, read and understand English or Spanish; * Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study; * One uterine fibroid must be identifiable and measurable by transvaginal ultrasound; * Menstrual cycle lasting from 24 to 36 days; * History of excessive menstrual bleeding; * Negative urine pregnancy test at screening.
Exclusion criteria
* Six months or more (immediately prior to Screening Visit) without a menstrual period; * Prior hysterectomy; * Prior bilateral oophorectomy; * Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study; * Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease; * Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV); * Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system; * Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC) | 4 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 25 mg Proellex 25 mg oral daily dose of Proellex
Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months | 0 |
| 50 mg Proellex 50 mg oral daily dose of Proellex
Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months | 0 |
| Placebo oral daily dose of placebo
Placebo: Two placebo capsules orally daily for up to four months | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study prematurely terminated | 77 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | — Participants |
| Age, Categorical >=65 years | — Participants |
| Age, Categorical Between 18 and 65 years | — 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
To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)
Time frame: 4 months
Population: Study prematurely terminated