Endometriosis
Conditions
Keywords
Endometriosis, Pelvic pain, Oral progesterone blocker
Brief summary
The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.
Interventions
DRUGProellex 25 mg
1 capsule daily for 4 months
DRUGPlacebo
1 capsule daily for 4 months
DRUGProellex 50 mg
2 capsules daily for 4 months
Sponsors
Repros Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No
Inclusion criteria
* Premenopausal women aged 18-48 inclusive * Endometriosis documented by laparoscopic or surgical assessment within the past ten (10) years * Clinical symptoms of endometriosis for at least the past three (3) months * Endometriosis symptoms * Must be sexually active unless sexually inactive for endometriosis-related dyspareunia * Must have a regular or steady menstrual cycle lasting from 24 to 36 days and a detectable ovulation during the baseline period using an ovulation monitoring kit (for timing of endometrial biopsy) * Other inclusion criteria may apply
Exclusion criteria
* Six (6) months or more without a menstrual period, or * Prior hysterectomy or * Prior bilateral oophorectomy * Diagnosis of osteopenia * Present history or condition that causes non-endometriosis-related dyspareunia * Presence of excessive bleeding or menorrhagia * Abnormal screening endometrial biopsy * Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score | 4 months |
| Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits | monthly |
| Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries | days |
| Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries | days |
| The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits | days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: 1 capsule daily for 4 months | 22 |
| 25 mg Proellex 25 mg: 1 capsule daily for 4 months | 22 |
| 50 mg Proellex 50 mg: 2 capsules daily for 4 months | 23 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 0 |
| Overall Study | Endometrial stripe not viewed on 2 tvu | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 0 | 3 |
| Overall Study | Not eligible | 1 | 1 | 2 |
| Overall Study | Personal issues | 4 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 3 | 0 |
Baseline characteristics
| Characteristic | Placebo | 25 mg | 50 mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 22 Participants | 23 Participants | 67 Participants |
| Region of Enrollment United States | 22 participants | 22 participants | 23 participants | 67 participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 23 Participants | 67 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 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 | 18 / 22 | 22 / 22 | 22 / 23 |
| serious Total, serious adverse events | 1 / 22 | 0 / 22 | 1 / 23 |
Outcome results
Primary
Difference Between the 25 mg and 50 mg Proellex Groups and Placebo Group in the Month 4 Subject Diary Composite Pain Score
Time frame: 4 months
Population: Zero participants were analyzed because no data were collected due to early termination
Primary
Difference Between the 50 mg Proellex Group and Placebo Group in the Month 4 Subject Diary Composite Pain Score
Time frame: 4 months
Population: Zero participants were analyzed because no data were collected due to early termination
Secondary
Difference Between Each Treatment Group in the Subject Diary Composite Pain Score at the Monthly Visits
Time frame: monthly
Population: Zero participants were analyzed because no data were collected due to early termination
Secondary
Duration of Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
Time frame: days
Population: Zero participants were analyzed because no data were collected due to early termination
Secondary
The Number of Days With Pain as Determined by Data Recorded in the Subject Diaries, Analyzed Between Treatment Groups at the Monthly Visits
Time frame: days
Population: Zero participants were analyzed because no data were collected due to early termination
Secondary
Time to Pain-free Assessments Using the Composite Pain Score as Determined by Data Recorded in the Subject Diaries
Time frame: days
Population: Zero participants were analyzed because no data were collected due to early termination