NCT02354534 · STUDY IN CONTEXT

Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Number of participants with serious adverse events or dose limiting toxicities related to the study intervention assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.

Source null

→

secondary · POSTED

Number of participants whose human papillomavirus (HPV) genotypes present at study entry become undetectable without surgical intervention. HPV genotyping detects strains of HPV present at each timepoint. For this outcome, we evaluated whether strains of HPV detected at study entry became undetectable during the study participation.

Subjects enrolled in the study who received at least one dose of the investigational drug, and on whom we have outcomes data. 2 participants did not have data collected for this outcome.

→

secondary · POSTED

Number of participants who had histologic regression from cervical intraepithelial neoplasia (CIN) 2/3 to CIN 1 or less, as assessed by colposcopically-directed biopsies. Histologic regression is defined as disappearance of the high grade lesion (CIN2/3) without surgical intervention.

All participants who received at least one dose of the interventional drug and on whom we have outcomes data. 2 participants did not have data collected for this outcome measure.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-uterine-neoplasm
nct id: NCT02354534
trial label: Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 3
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0000
source section id
NCT02354534-om-0000
source outcome index
0
endpoint
Number of Participants With Serious Adverse Events
endpoint definition
Number of participants with serious adverse events or dose limiting toxicities related to the study intervention assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.
time origin
41 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0001
source section id
NCT02354534-om-0001
source outcome index
1
endpoint
Viral Clearance of HPV
endpoint definition
Number of participants whose human papillomavirus (HPV) genotypes present at study entry become undetectable without surgical intervention. HPV genotyping detects strains of HPV present at each timepoint. For this outcome, we evaluated whether strains of HPV detected at study entry became undetectable during the study participation.
time origin
41 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Subjects enrolled in the study who received at least one dose of the investigational drug, and on whom we have outcomes data. 2 participants did not have data collected for this outcome.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0002
source section id
NCT02354534-om-0002
source outcome index
2
endpoint
Histologic Regression of CIN2/3
endpoint definition
Number of participants who had histologic regression from cervical intraepithelial neoplasia (CIN) 2/3 to CIN 1 or less, as assessed by colposcopically-directed biopsies. Histologic regression is defined as disappearance of the high grade lesion (CIN2/3) without surgical intervention.
time origin
41 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least one dose of the interventional drug and on whom we have outcomes data. 2 participants did not have data collected for this outcome measure.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0000
arm key
OG000
arm label
50 mg Artesunate Suppositories, 1 Cycle
regimen
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02354534-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0000
arm key
OG001
arm label
200 mg Artesunate Suppositories, 1 Cycle
regimen
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02354534-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0000
arm key
OG002
arm label
200 mg Artesunate Suppositories,2 Cycles
regimen
Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02354534-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0000
arm key
OG003
arm label
200 mg Artesunate Suppositories,3 Cycles
regimen
Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02354534-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0001
arm key
OG000
arm label
50 mg Artesunate Suppositories, 1 Cycle
regimen
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02354534-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0001
arm key
OG001
arm label
200 mg Artesunate Suppositories, 1 Cycle
regimen
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02354534-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0001
arm key
OG002
arm label
200 mg Artesunate Suppositories,2 Cycles
regimen
Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02354534-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0001
arm key
OG003
arm label
200 mg Artesunate Suppositories,3 Cycles
regimen
Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02354534-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0002
arm key
OG000
arm label
50 mg Artesunate Suppositories, 1 Cycle
regimen
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02354534-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0002
arm key
OG001
arm label
200 mg Artesunate Suppositories, 1 Cycle
regimen
Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02354534-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0002
arm key
OG002
arm label
200 mg Artesunate Suppositories,2 Cycles
regimen
Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02354534-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
outcome key
om-0002
arm key
OG003
arm label
200 mg Artesunate Suppositories,3 Cycles
regimen
Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02354534-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
harm key
EG000
source section id
NCT02354534-ae
event group key
EG000
event group label
50 mg Artesunate Suppositories, 1 Cycle
serious affected
0
serious at risk
3
other affected
2
other at risk
3
frequency threshold
0
collection period
41 weeks
event definition
All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
harm key
EG001
source section id
NCT02354534-ae
event group key
EG001
event group label
200 mg Artesunate Suppositories, 1 Cycle
serious affected
0
serious at risk
9
other affected
9
other at risk
9
frequency threshold
0
collection period
41 weeks
event definition
All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
harm key
EG002
source section id
NCT02354534-ae
event group key
EG002
event group label
200 mg Artesunate Suppositories,2 Cycles
serious affected
0
serious at risk
10
other affected
8
other at risk
10
frequency threshold
0
collection period
41 weeks
event definition
All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-uterine-neoplasm
nct id
NCT02354534
harm key
EG003
source section id
NCT02354534-ae
event group key
EG003
event group label
200 mg Artesunate Suppositories,3 Cycles
serious affected
0
serious at risk
8
other affected
8
other at risk
8
frequency threshold
0
collection period
41 weeks
event definition
All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice