Trial Outcomes & Findings for Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids (NCT NCT01451424)
NCT ID: NCT01451424
Last Updated: 2014-08-29
Results Overview
Change from baseline in vaginal bleeding assessed at the end of treatment (12 or 16 weeks) using a Pictorial Blood Loss Assessment Chart (PBAC), which measures volume (mL) of blood loss over a 28-day period Less blood loss represents an improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
12 or 16 weeks
Results posted on
2014-08-29
Participant Flow
Participant milestones
| Measure |
Proellex 3 mg Per Protocol
Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks
All subjects completed the placebo run-in period and started active dosing.
|
Proellex 6 mg Per Protocol
Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
All subjects completed the placebo run-in period and started active dosing.
|
Proellex 12 mg Per Protocol
Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1, PK group) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks
The first 6 subjects (arm 1) had no placebo run-in period. Arm 3 subjects all completed the placebo run-in period and started active dosing.
|
24 mg Proellex
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
All subjects completed the placebo run-in period and started active dosing.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
12
|
10
|
|
Overall Study
COMPLETED
|
8
|
7
|
11
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
5
|
Reasons for withdrawal
| Measure |
Proellex 3 mg Per Protocol
Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks
All subjects completed the placebo run-in period and started active dosing.
|
Proellex 6 mg Per Protocol
Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
All subjects completed the placebo run-in period and started active dosing.
|
Proellex 12 mg Per Protocol
Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1, PK group) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks
The first 6 subjects (arm 1) had no placebo run-in period. Arm 3 subjects all completed the placebo run-in period and started active dosing.
|
24 mg Proellex
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
All subjects completed the placebo run-in period and started active dosing.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids
Baseline characteristics by cohort
| Measure |
Proellex 3 mg Per Protocol
n=9 Participants
Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 6 mg Per Protocol
n=9 Participants
Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 12 mg Per Protocol
n=12 Participants
Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 weeks Includes subjects from both arms 1 and 3 (PK group and non-PK groups)
|
24 mg Proellex
n=10 Participants
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.7 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
39.8 years
STANDARD_DEVIATION 5.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
10 participants
n=4 Participants
|
40 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 or 16 weeksPopulation: MITT population
Change from baseline in vaginal bleeding assessed at the end of treatment (12 or 16 weeks) using a Pictorial Blood Loss Assessment Chart (PBAC), which measures volume (mL) of blood loss over a 28-day period Less blood loss represents an improvement.
Outcome measures
| Measure |
Proellex 3 mg Per Protocol
n=8 Participants
Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 6 mg Per Protocol
n=7 Participants
Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 12 mg Per Protocol
n=10 Participants
Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks
|
24 mg Proellex
n=4 Participants
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
|
24 mg Proellex
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline in Vaginal Bleeding
|
-83.5 mL
Interval -102.0 to -4.0
|
-36.0 mL
Interval -124.0 to 266.0
|
-63.5 mL
Interval -242.0 to -14.0
|
-39.5 mL
Interval -201.0 to -17.0
|
—
|
SECONDARY outcome
Timeframe: 12 or 16 weeksPopulation: Subjects with end of treatment PK assessment
Determination of Cmax of Proellex at end of treatment
Outcome measures
| Measure |
Proellex 3 mg Per Protocol
n=6 Participants
Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 6 mg Per Protocol
n=7 Participants
Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 12 mg Per Protocol
n=7 Participants
Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks
|
24 mg Proellex
n=5 Participants
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
|
24 mg Proellex
n=5 Participants
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
|
|---|---|---|---|---|---|
|
Blood Levels of Proellex
|
11.1 ng/dL
Standard Deviation 5.1
|
14.1 ng/dL
Standard Deviation 6.6
|
11.6 ng/dL
Standard Deviation 2.0
|
7.4 ng/dL
Standard Deviation 5.3
|
10.2 ng/dL
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: 12 or 16 weeksPopulation: MITT population
Percent change in volume of confirmed uterine fibroids at end of treatment, assessed by MRI
Outcome measures
| Measure |
Proellex 3 mg Per Protocol
n=8 Participants
Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 6 mg Per Protocol
n=7 Participants
Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 12 mg Per Protocol
n=10 Participants
Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks
|
24 mg Proellex
n=4 Participants
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
|
24 mg Proellex
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
|
|---|---|---|---|---|---|
|
Uterine Fibroid Size
|
-9.9 Percentage change
Interval -50.7 to 35.8
|
-13.4 Percentage change
Interval -28.1 to 21.3
|
-21.9 Percentage change
Interval -42.8 to -9.6
|
-3.5 Percentage change
Interval -61.5 to 11.5
|
—
|
SECONDARY outcome
Timeframe: End of treatmentPercentage of subjects with induced amenorrhea during last 28 days on drug Amenorrhea was deemed to be achieved if no daily bleeding score was greater than 1 during the last 28 calendar days of the dosing period. A score of 1 was to be indicated if spotting was observed which did not require a sanitary product. Subjects that terminated early were deemed not to have achieved amenorrhea.
Outcome measures
| Measure |
Proellex 3 mg Per Protocol
n=9 Participants
Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 6 mg Per Protocol
n=9 Participants
Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 12 mg Per Protocol
n=12 Participants
Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks
|
24 mg Proellex
n=10 Participants
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
|
24 mg Proellex
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
|
|---|---|---|---|---|---|
|
Induction of Amenorrhea at End of Treatment
|
55.6 Percentage of particpants
|
0 Percentage of particpants
|
66.7 Percentage of particpants
|
40.0 Percentage of particpants
|
—
|
SECONDARY outcome
Timeframe: 12 or 16 weeksPopulation: Safety population, data based on subjects with both baseline and end of treatment assessments
Percent change in median endometrial thickness from baseline to end of treatment assessed by ultrasound determination of uterine stripe.
Outcome measures
| Measure |
Proellex 3 mg Per Protocol
n=9 Participants
Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 6 mg Per Protocol
n=6 Participants
Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 12 mg Per Protocol
n=12 Participants
Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks
|
24 mg Proellex
n=4 Participants
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
|
24 mg Proellex
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
|
|---|---|---|---|---|---|
|
Endometrial Thickness
|
60.8 Percent change
Interval -38.1 to 144.0
|
-25.8 Percent change
Interval -83.8 to 746.2
|
39.3 Percent change
Interval -52.7 to 243.8
|
32.3 Percent change
Interval -64.3 to 116.7
|
—
|
SECONDARY outcome
Timeframe: 12 or 16 weeksPopulation: MITT. Note: lower score is improvement
Percentage change from baseline in median quality of life using uterine fibroid symptom and quality of life questionnaire (UFSQOL)
Outcome measures
| Measure |
Proellex 3 mg Per Protocol
n=8 Participants
Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 6 mg Per Protocol
n=7 Participants
Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 12 mg Per Protocol
n=10 Participants
Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks
Proellex: vaginal suppository, daily, for 12 or 16 weeks
The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks
|
24 mg Proellex
n=3 Participants
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
|
24 mg Proellex
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 16 weeks
|
|---|---|---|---|---|---|
|
Change in Quality of Life
|
-67.9 Percent change
Interval -100.0 to 21.7
|
-8.5 Percent change
Interval -100.0 to 117.4
|
-98.2 Percent change
Interval -100.0 to -42.9
|
-100.0 Percent change
Interval -100.0 to -100.0
|
—
|
Adverse Events
Proellex 3 mg Per Protocol
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Proellex 6 mg Per Protocol
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Proellex 12 mg Per Protocol
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
24 mg Proellex
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Proellex 3 mg Per Protocol
n=9 participants at risk
Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 6 mg Per Protocol
n=9 participants at risk
Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 12 mg Per Protocol
n=12 participants at risk
Subjects receiving 12 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
|
24 mg Proellex
n=10 participants at risk
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 12 weeks
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
11.1%
1/9 • Number of events 1
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
General disorders
Chest pain
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
10.0%
1/10 • Number of events 1
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
Other adverse events
| Measure |
Proellex 3 mg Per Protocol
n=9 participants at risk
Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 6 mg Per Protocol
n=9 participants at risk
Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
|
Proellex 12 mg Per Protocol
n=12 participants at risk
Subjects receiving 12 mg Proellex daily, vaginally for 12 weeks
Proellex: vaginal suppository, daily, for 12 weeks
|
24 mg Proellex
n=10 participants at risk
24 mg vaginal Proellex daily
Proellex: vaginal suppository, daily, for 12 weeks
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Nervous system disorders
Sleepiness
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
8.3%
1/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Reproductive system and breast disorders
Vaginal dryness
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Reproductive system and breast disorders
Vaginal yeast infection
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Reproductive system and breast disorders
Atypical squamous cells of undetermined significance
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
8.3%
1/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Reproductive system and breast disorders
Trichomonous vaginalis
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Vascular disorders
Hypertension
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Gastrointestinal disorders
Tooth infection
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Skin and subcutaneous tissue disorders
Rask
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
11.1%
1/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
General disorders
Fatigue
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
8.3%
1/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
16.7%
2/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Nervous system disorders
Headache
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
8.3%
1/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
10.0%
1/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Vascular disorders
Hot flashes
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
8.3%
1/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Nervous system disorders
Tingling sensation both thighs
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
8.3%
1/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
General disorders
Chest pain
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
10.0%
1/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
|
Endocrine disorders
Thyroid enlargement
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/9
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
0.00%
0/12
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
10.0%
1/10
The Proellex 12 mg Per Protocol Arm/Group includes both Stage 1 and Stage 2 participants, i.e. all subjects dosed at 12 mg
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER