Trial Outcomes & Findings for Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix (NCT NCT00285207)
NCT ID: NCT00285207
Last Updated: 2010-10-11
Results Overview
Pathological resonse is defined as a patient who regressed from Cervical intraepithelial neoplasia (CIN) 2/3 to normal at the end of 4 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
baseline and 4 months
Results posted on
2010-10-11
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo (no treatment)
|
A007
Experimental A007
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
77
|
|
Overall Study
Treated
|
63
|
75
|
|
Overall Study
COMPLETED
|
61
|
71
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Placebo (no treatment)
|
A007
Experimental A007
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
|
Overall Study
Pregnancy
|
1
|
1
|
|
Overall Study
non-compliance
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
Baseline characteristics by cohort
| Measure |
Placebo
n=70 Participants
Placebo (no treatment)
|
A007
n=77 Participants
Experimental A007
|
Total
n=147 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
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
28 years
STANDARD_DEVIATION 6 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
28.4 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
77 participants
n=7 Participants
|
147 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 4 monthsPathological resonse is defined as a patient who regressed from Cervical intraepithelial neoplasia (CIN) 2/3 to normal at the end of 4 months.
Outcome measures
| Measure |
Placebo
n=70 Participants
Placebo (no treatment)
|
A007
n=77 Participants
Experimental A007
|
|---|---|---|
|
Pathological Response
|
20 participants
|
24 participants
|
SECONDARY outcome
Timeframe: over the course of the trialOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: over the course of the trialOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: over the course of the trialOutcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
A007
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=63 participants at risk
Placebo (no treatment)
|
A007
n=75 participants at risk
Experimental A007
|
|---|---|---|
|
General disorders
Headache
|
3.2%
2/63
|
6.7%
5/75
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place