Uterine Fibroids
Conditions
Keywords
Uterine Fibroids
Brief summary
Safety and efficacy study of 25 and 50 mg doses of Proellex
Detailed description
The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.
Interventions
DRUGProellex
2, 25 mg capsules once per day
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU) * Subject has a menstrual cycle lasting from 20 to 40 days. * Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Exclusion criteria
* Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304. * Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) | During two 4 month treatment periods |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 50 mg Proellex® Proellex: 2, 25 mg capsules once per day | 0 |
| 25 mg Proellex® Proellex: 1, 25 mg capsule once per day | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study prematurely terminated | 27 |
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 Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)
Time frame: During two 4 month treatment periods