Uterine Fibroids
Conditions
Keywords
Uterine Fibroids
Brief summary
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
Detailed description
Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.
Interventions
DRUGProellex 25 mg
One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
DRUGProellex 50 mg
Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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. Additional inclusion criteria may apply.
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. Additional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle) | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 25 mg Proellex Proellex 25 mg once daily
Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle | 0 |
| Proellex 50 mg Proellex 50 mg once daily
Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study prematurely terminated | 175 |
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 |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)
Time frame: 12 months
Population: Study prematurely terminated