Trial Outcomes & Findings for Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis (NCT NCT00556075)
NCT ID: NCT00556075
Last Updated: 2014-08-25
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
4 months
Results posted on
2014-08-25
Participant Flow
Participant milestones
| Measure |
C Placebo
Placebo: 1 capsule daily for 4 months
|
A 25 mg
Proellex 25 mg: 1 capsule daily for 4 months
|
B 50 mg
Proellex 50 mg: 2 capsules daily for 4 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
23
|
|
Overall Study
COMPLETED
|
9
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
8
|
Reasons for withdrawal
| Measure |
C Placebo
Placebo: 1 capsule daily for 4 months
|
A 25 mg
Proellex 25 mg: 1 capsule daily for 4 months
|
B 50 mg
Proellex 50 mg: 2 capsules daily for 4 months
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
3
|
|
Overall Study
Not eligible
|
1
|
1
|
2
|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
|
Overall Study
Personal issues
|
4
|
1
|
0
|
|
Overall Study
Endometrial stripe not viewed on 2 tvu
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
Baseline characteristics by cohort
| Measure |
Placebo
n=22 Participants
Placebo: 1 capsule daily for 4 months
|
25 mg
n=22 Participants
Proellex 25 mg: 1 capsule daily for 4 months
|
50 mg
n=23 Participants
Proellex 50 mg: 2 capsules daily for 4 months
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
67 Participants
n=4 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
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
23 participants
n=5 Participants
|
67 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Zero participants were analyzed because no data were collected due to early termination
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 monthsPopulation: Zero participants were analyzed because no data were collected due to early termination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: monthlyPopulation: Zero participants were analyzed because no data were collected due to early termination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: daysPopulation: Zero participants were analyzed because no data were collected due to early termination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: daysPopulation: Zero participants were analyzed because no data were collected due to early termination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: daysPopulation: Zero participants were analyzed because no data were collected due to early termination
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
25 mg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
50 mg
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=22 participants at risk
Placebo: 1 capsule daily for 4 months
|
25 mg
n=22 participants at risk
Proellex 25 mg: 1 capsule daily for 4 months
|
50 mg
n=23 participants at risk
Proellex 50 mg: 2 capsules daily for 4 months
|
|---|---|---|---|
|
Investigations
Elevated LFTs
|
0.00%
0/22
|
0.00%
0/22
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Grand Mal Seizure
|
4.5%
1/22 • Number of events 1
|
0.00%
0/22
|
0.00%
0/23
|
Other adverse events
| Measure |
Placebo
n=22 participants at risk
Placebo: 1 capsule daily for 4 months
|
25 mg
n=22 participants at risk
Proellex 25 mg: 1 capsule daily for 4 months
|
50 mg
n=23 participants at risk
Proellex 50 mg: 2 capsules daily for 4 months
|
|---|---|---|---|
|
Gastrointestinal disorders
Adominal pain
|
22.7%
5/22
|
13.6%
3/22
|
34.8%
8/23
|
|
Gastrointestinal disorders
Nausea
|
13.6%
3/22
|
36.4%
8/22
|
47.8%
11/23
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
1/22
|
13.6%
3/22
|
4.3%
1/23
|
|
General disorders
Fatigue
|
0.00%
0/22
|
9.1%
2/22
|
4.3%
1/23
|
|
General disorders
Irritability
|
0.00%
0/22
|
0.00%
0/22
|
8.7%
2/23
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/22
|
0.00%
0/22
|
8.7%
2/23
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/22
|
18.2%
4/22
|
0.00%
0/23
|
|
Infections and infestations
Sinusitis
|
9.1%
2/22
|
9.1%
2/22
|
0.00%
0/23
|
|
Infections and infestations
URI
|
18.2%
4/22
|
4.5%
1/22
|
17.4%
4/23
|
|
Infections and infestations
UTI
|
4.5%
1/22
|
13.6%
3/22
|
4.3%
1/23
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
9.1%
2/22
|
4.5%
1/22
|
13.0%
3/23
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/22
|
0.00%
0/22
|
13.0%
3/23
|
|
Investigations
Bone density decreased
|
9.1%
2/22
|
18.2%
4/22
|
47.8%
11/23
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/22
|
13.6%
3/22
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
1/22
|
0.00%
0/22
|
13.0%
3/23
|
|
Nervous system disorders
Dizziness
|
0.00%
0/22
|
9.1%
2/22
|
17.4%
4/23
|
|
Nervous system disorders
Headache
|
4.5%
1/22
|
18.2%
4/22
|
26.1%
6/23
|
|
Nervous system disorders
Migraine
|
0.00%
0/22
|
0.00%
0/22
|
8.7%
2/23
|
|
Reproductive system and breast disorders
Cervical cyst
|
4.5%
1/22
|
4.5%
1/22
|
8.7%
2/23
|
|
Reproductive system and breast disorders
Endometrial disorder
|
0.00%
0/22
|
9.1%
2/22
|
13.0%
3/23
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
4.5%
1/22
|
4.5%
1/22
|
13.0%
3/23
|
|
Reproductive system and breast disorders
Ovarian cyst
|
72.7%
16/22
|
45.5%
10/22
|
65.2%
15/23
|
|
Reproductive system and breast disorders
Parovarian cyst
|
0.00%
0/22
|
4.5%
1/22
|
8.7%
2/23
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/22
|
9.1%
2/22
|
4.3%
1/23
|
|
Vascular disorders
Hot flush
|
0.00%
0/22
|
18.2%
4/22
|
30.4%
7/23
|
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