Trial Outcomes & Findings for Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia (NCT NCT00303823)
NCT ID: NCT00303823
Last Updated: 2015-05-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
4 months
Results posted on
2015-05-05
Participant Flow
Participant milestones
| Measure |
Polyphenon E (Defined Green Tea Catechin Extract)
Patients receive oral Polyphenon E daily for 16 weeks
|
Placebo
Patients receive oral placebo once daily for 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
|
Overall Study
COMPLETED
|
35
|
38
|
|
Overall Study
NOT COMPLETED
|
15
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia
Baseline characteristics by cohort
| Measure |
Polyphenon E
n=50 Participants
|
Placebo
n=48 Participants
|
Total
n=98 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
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
98 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
|
28.48 years
STANDARD_DEVIATION 8.78 • n=5 Participants
|
28.27 years
STANDARD_DEVIATION 8.05 • n=7 Participants
|
28.28 years
STANDARD_DEVIATION 8.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
98 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
|
50 participants
n=5 Participants
|
48 participants
n=7 Participants
|
98 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsOutcome measures
| Measure |
Polyphenon E
n=41 Participants
|
Placebo
n=41 Participants
|
|---|---|---|
|
Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease
|
7 participants
|
6 participants
|
PRIMARY outcome
Timeframe: 4 monthsOutcome measures
| Measure |
Polyphenon E
n=41 Participants
|
Placebo
n=41 Participants
|
|---|---|---|
|
Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia
|
1 participants
|
6 participants
|
PRIMARY outcome
Timeframe: 4 monthsOutcome measures
| Measure |
Polyphenon E
n=41 Participants
|
Placebo
n=41 Participants
|
|---|---|---|
|
No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia
|
27 participants
|
26 participants
|
PRIMARY outcome
Timeframe: 4 monthsOutcome measures
| Measure |
Polyphenon E
n=41 Participants
|
Placebo
n=41 Participants
|
|---|---|---|
|
Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer
|
6 participants
|
3 participants
|
Adverse Events
Polyphenon E
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Polyphenon E
n=50 participants at risk
|
Placebo
n=48 participants at risk
|
|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/50
|
2.1%
1/48
|
Other adverse events
| Measure |
Polyphenon E
n=50 participants at risk
|
Placebo
n=48 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.0%
2/50
|
8.3%
4/48
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/50
|
6.2%
3/48
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/50
|
6.2%
3/48
|
|
Gastrointestinal disorders
Nausea
|
32.0%
16/50
|
18.8%
9/48
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
3/50
|
2.1%
1/48
|
|
Infections and infestations
Cervicitis
|
12.0%
6/50
|
6.2%
3/48
|
|
Infections and infestations
Sinusitis
|
6.0%
3/50
|
0.00%
0/48
|
|
Investigations
ALT increased
|
10.0%
5/50
|
2.1%
1/48
|
|
Investigations
AST increased
|
8.0%
4/50
|
2.1%
1/48
|
|
Nervous system disorders
Dizziness
|
14.0%
7/50
|
6.2%
3/48
|
|
General disorders
Fatigue
|
8.0%
4/50
|
8.3%
4/48
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50
|
6.2%
3/48
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/50
|
8.3%
4/48
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory disorders
|
8.0%
4/50
|
6.2%
3/48
|
|
Reproductive system and breast disorders
Irregular menses
|
6.0%
3/50
|
4.2%
2/48
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/50
|
8.3%
4/48
|
|
Reproductive system and breast disorders
Other reproductive system disorders
|
2.0%
1/50
|
6.2%
3/48
|
|
Gastrointestinal disorders
Abdomen pain
|
4.0%
2/50
|
8.3%
4/48
|
|
Gastrointestinal disorders
Stomach pain
|
12.0%
6/50
|
8.3%
4/48
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.0%
4/50
|
8.3%
4/48
|
|
General disorders
Other pain
|
2.0%
1/50
|
6.2%
3/48
|
|
Nervous system disorders
Headache
|
26.0%
13/50
|
27.1%
13/48
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
3/50
|
4.2%
2/48
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60