Amenorrhea
Conditions
Keywords
Menstruation
Brief summary
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.
Detailed description
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able to suppress endogenous progesterone in women. It is believed that giving Proellex in the early/mid-luteal phase of the cycle will suppress the effects of endogenous progesterone triggering the end of the cycle and inducing menstruation as happens naturally
Interventions
DRUGPlacebo
Placebo, 1 capsule daily for five days
DRUGProellex
Proellex, one 3, 6, 12 or 25 mg capsule daily for five days
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Clinical laboratory tests within normal ranges * A normal menstrual period of 26-30 days * Desiring not to become pregnant * Agreeing to use a double barrier method of birth control for the duration of the trial
Exclusion criteria
* Post-menopausal status * Aamenorrhea or dysfunctional uterine bleeding * Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile * Subjects with a Body Mass Index (BMI) below 18 or over 39
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Day of Initial Vaginal Bleeding Event Following Treatment With Proellex. | An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Vaginal Bleeding Following Treatment With Proellex. | At least 2 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.
Placebo: Placebo, 1 capsule daily for five days | 0 |
| 3 mg Proellex First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days | 0 |
| 6 mg Proellex Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days | 0 |
| 12 mg Proellex Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days | 0 |
| 25 mg Proellex Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.
Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study prematurely terminated | 11 |
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 | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Day of Initial Vaginal Bleeding Event Following Treatment With Proellex.
Time frame: An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses
Population: Study prematurely terminated
Secondary
Duration of Vaginal Bleeding Following Treatment With Proellex.
Time frame: At least 2 days
Population: Study prematurely terminated