Trial Outcomes & Findings for Determination of the Lowest, Safe and Effective Dose of Proellex (NCT NCT01187043)
NCT ID: NCT01187043
Last Updated: 2014-07-28
Results Overview
Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding. Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
10 weeks
Results posted on
2014-07-28
Participant Flow
Participant milestones
| Measure |
ARM 1
1 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 2
3 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 3
6 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 4
9 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 5
12 mg proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
10
|
8
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
4
|
0
|
2
|
Reasons for withdrawal
| Measure |
ARM 1
1 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 2
3 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 3
6 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 4
9 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 5
12 mg proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Unable to make scheduled visits
|
1
|
0
|
4
|
0
|
1
|
Baseline Characteristics
Determination of the Lowest, Safe and Effective Dose of Proellex
Baseline characteristics by cohort
| Measure |
ARM 1
n=12 Participants
1 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 2
n=10 Participants
3 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 3
n=12 Participants
6 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 4
n=12 Participants
9 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 5
n=12 Participants
12 mg proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
37.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
34.4 years
STANDARD_DEVIATION 8.3 • n=4 Participants
|
36.3 years
STANDARD_DEVIATION 7.0 • n=21 Participants
|
36.7 years
STANDARD_DEVIATION 7.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
58 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
12 participants
n=21 Participants
|
58 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Per protocol: subjects who exhibited trough levels of proellex on at least 7 of the 10 weekly visits during the dosing period
Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding. Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.
Outcome measures
| Measure |
ARM 1
n=2 Participants
1 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 2
n=9 Participants
3 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 3
n=7 Participants
6 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 4
n=10 Participants
9 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 5
n=7 Participants
12 mg proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
|---|---|---|---|---|---|
|
Induction Amenorrhea
|
2 participants
|
9 participants
|
6 participants
|
8 participants
|
6 participants
|
Adverse Events
ARM 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
ARM 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
ARM 3
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
ARM 4
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
ARM 5
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARM 1
n=12 participants at risk
1 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 2
n=10 participants at risk
3 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 3
n=12 participants at risk
6 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 4
n=12 participants at risk
9 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 5
n=12 participants at risk
12 mg proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
Other adverse events
| Measure |
ARM 1
n=12 participants at risk
1 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 2
n=10 participants at risk
3 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 3
n=12 participants at risk
6 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 4
n=12 participants at risk
9 mg Proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
ARM 5
n=12 participants at risk
12 mg proellex
Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Ear and labyrinth disorders
Right ear ache
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Gastrointestinal disorders
Abdominal cramps
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Gastrointestinal disorders
Emesis
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
16.7%
2/12 • Number of events 2 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
16.7%
2/12 • Number of events 2 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 2 • From first dose to one week post dosing (about 11 weeks).
|
|
General disorders
Fatigue
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
General disorders
Facial pain
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
16.7%
2/12 • Number of events 2 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Infections and infestations
Pustule
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Infections and infestations
Tooth abcess
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Infections and infestations
URI
|
8.3%
1/12 • Number of events 2 • From first dose to one week post dosing (about 11 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
16.7%
2/12 • Number of events 2 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
|
Infections and infestations
UTI
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Infections and infestations
Viral gastroenteritis
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
|
Injury, poisoning and procedural complications
Insect bite
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
16.7%
2/12 • Number of events 2 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Injury, poisoning and procedural complications
Ankle sprain
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
|
Injury, poisoning and procedural complications
Abrasion
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Investigations
Abnormal PAP smear
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Investigations
Weight gain
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Musculoskeletal and connective tissue disorders
Elbow pain
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arm pain
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 2 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
16.7%
2/12 • Number of events 2 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
33.3%
4/12 • Number of events 4 • From first dose to one week post dosing (about 11 weeks).
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Nervous system disorders
Vasovagal episode
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Reproductive system and breast disorders
Irregular menses
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
10.0%
1/10 • Number of events 1 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
16.7%
2/12 • Number of events 2 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Reproductive system and breast disorders
Menstrual cramps
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Reproductive system and breast disorders
Mittelschmertz
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
10.0%
1/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
10.0%
1/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Reproductive system and breast disorders
Yeast infection
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
10.0%
1/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
10.0%
1/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Skin and subcutaneous tissue disorders
Benign breast lesion
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
|
Vascular disorders
Hot flashes
|
8.3%
1/12 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/10 • From first dose to one week post dosing (about 11 weeks).
|
0.00%
0/12 • From first dose to one week post dosing (about 11 weeks).
|
16.7%
2/12 • From first dose to one week post dosing (about 11 weeks).
|
25.0%
3/12 • From first dose to one week post dosing (about 11 weeks).
|
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