Trial · NCT02354534

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

NCT02354534, Phase 1, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2021-04-02

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3). Trials, record NCT02354534. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02354534

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
NCT number: NCT02354534
Status: Completed
Phases: Phase 1
Enrollment: 30 participants, actual
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions: Cervical Intraepithelial Neoplasia Grade 2/3, High-risk HPV (Any Strain)
Interventions: Artesunate Suppositories
First posted: 2015-02-03
Last updated: 2021-04-28
Results first posted: 2021-04-02

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Serious Adverse Events	41 weeks	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.
Secondary	Viral Clearance of HPV	41 weeks	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.
Secondary	Histologic Regression of CIN2/3	41 weeks	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Serious Adverse Events	41 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Viral Clearance of HPV	41 weeks	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Histologic Regression of CIN2/3	41 weeks	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.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Serious Adverse Events	50 mg Artesunate Suppositories, 1 Cycle	0	Participants
Number of Participants With Serious Adverse Events	200 mg Artesunate Suppositories, 1 Cycle	0	Participants
Number of Participants With Serious Adverse Events	200 mg Artesunate Suppositories,2 Cycles	0	Participants
Number of Participants With Serious Adverse Events	200 mg Artesunate Suppositories,3 Cycles	0	Participants
Viral Clearance of HPV	50 mg Artesunate Suppositories, 1 Cycle	1	Participants
Viral Clearance of HPV	200 mg Artesunate Suppositories, 1 Cycle	3	Participants
Viral Clearance of HPV	200 mg Artesunate Suppositories,2 Cycles	4	Participants
Viral Clearance of HPV	200 mg Artesunate Suppositories,3 Cycles	1	Participants
Histologic Regression of CIN2/3	50 mg Artesunate Suppositories, 1 Cycle	2	Participants
Histologic Regression of CIN2/3	200 mg Artesunate Suppositories, 1 Cycle	7	Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	50 mg Artesunate Suppositories, 1 Cycle	3
Overall Study	STARTED	200 mg Artesunate Suppositories, 1 Cycle	9
Overall Study	STARTED	200 mg Artesunate Suppositories,2 Cycles	10
Overall Study	STARTED	200 mg Artesunate Suppositories,3 Cycles	8
Overall Study	COMPLETED	50 mg Artesunate Suppositories, 1 Cycle	3
Overall Study	COMPLETED	200 mg Artesunate Suppositories, 1 Cycle	9
Overall Study	COMPLETED	200 mg Artesunate Suppositories,2 Cycles	9
Overall Study	COMPLETED	200 mg Artesunate Suppositories,3 Cycles	8
Overall Study	NOT COMPLETED	50 mg Artesunate Suppositories, 1 Cycle	0
Overall Study	NOT COMPLETED	200 mg Artesunate Suppositories, 1 Cycle	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events116

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Bloating	Gastrointestinal disorders	50 mg Artesunate Suppositories, 1 Cycle	1	3	4
other	Bloating	Gastrointestinal disorders	200 mg Artesunate Suppositories, 1 Cycle	1	9	1
other	Bloating	Gastrointestinal disorders	200 mg Artesunate Suppositories,2 Cycles	0	10	0
other	Bloating	Gastrointestinal disorders	200 mg Artesunate Suppositories,3 Cycles	0	8	0
other	Tinnitus	Ear and labyrinth disorders	50 mg Artesunate Suppositories, 1 Cycle	0	3	0
other	Tinnitus	Ear and labyrinth disorders	200 mg Artesunate Suppositories, 1 Cycle	1	9	1
other	Tinnitus	Ear and labyrinth disorders	200 mg Artesunate Suppositories,2 Cycles	1	10	2
other	Tinnitus	Ear and labyrinth disorders	200 mg Artesunate Suppositories,3 Cycles	0	8	0
other	Abdominal pain	Gastrointestinal disorders	50 mg Artesunate Suppositories, 1 Cycle	0	3	0
other	Abdominal pain	Gastrointestinal disorders	200 mg Artesunate Suppositories, 1 Cycle	0	9	0

1 to 10 of 116Source ClinicalTrials.gov

See all 116 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	50 mg Artesunate Suppositories, 1 Cycle	0	3
Total, all-cause mortality	200 mg Artesunate Suppositories, 1 Cycle	0	9
Total, all-cause mortality	200 mg Artesunate Suppositories,2 Cycles	0	10
Total, all-cause mortality	200 mg Artesunate Suppositories,3 Cycles	0	8
Total, other adverse events	50 mg Artesunate Suppositories, 1 Cycle	2	3
Total, other adverse events	200 mg Artesunate Suppositories, 1 Cycle	9	9
Total, other adverse events	200 mg Artesunate Suppositories,2 Cycles	8	10
Total, other adverse events	200 mg Artesunate Suppositories,3 Cycles	8	8
Total, serious adverse events	50 mg Artesunate Suppositories, 1 Cycle	0	3
Total, serious adverse events	200 mg Artesunate Suppositories, 1 Cycle	0	9

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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