NCT02354534 · OUTCOME

Histologic Regression of CIN2/3

Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3) · Source last updated 2021-04-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 41 weeks

What was measured

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.

Analysis population: 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.

Groups in this outcome

50 mg Artesunate Suppositories, 1 Cycle

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

200 mg Artesunate Suppositories, 1 Cycle

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

200 mg Artesunate Suppositories,2 Cycles

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

200 mg Artesunate Suppositories,3 Cycles

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
50 mg Artesunate Suppositories, 1 Cycle	3
200 mg Artesunate Suppositories, 1 Cycle	9
200 mg Artesunate Suppositories,2 Cycles	8
200 mg Artesunate Suppositories,3 Cycles	8

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
50 mg Artesunate Suppositories, 1 Cycle	2	Not reported	Not reported	Not reported	Not reported
200 mg Artesunate Suppositories, 1 Cycle	7	Not reported	Not reported	Not reported	Not reported
200 mg Artesunate Suppositories,2 Cycles	5	Not reported	Not reported	Not reported	Not reported
200 mg Artesunate Suppositories,3 Cycles	5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
7
group Id
OG002
value
5
group Id
OG003
value
5

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
9
group Id
OG002
value
8
group Id
OG003
value
8
units
Participants

description

groups

description
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
id
OG000
title
50 mg Artesunate Suppositories, 1 Cycle
description
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
id
OG001
title
200 mg Artesunate Suppositories, 1 Cycle
description
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
id
OG002
title
200 mg Artesunate Suppositories,2 Cycles
description
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
id
OG003
title
200 mg Artesunate Suppositories,3 Cycles

param Type

COUNT_OF_PARTICIPANTS

population Description

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.

reporting Status

POSTED

time Frame

41 weeks

title

Histologic Regression of CIN2/3

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice