Trial · NCT06263582
Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya
NCT06263582, Phase 1, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2025-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya. Trials, record NCT06263582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06263582
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya
- NCT number
- NCT06263582
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Cervix Cancer, Cervix Intraepithelial Neoplasia Grade 3, Cervix; Intraepithelial Neoplasia, Grade I, Cervix; Intraepithelial Neoplasia, Grade II
- Interventions
- Artesunate pessary, blood draws for pharmacokinetics of the study drug
- First posted
- 2024-02-16
- Last updated
- 2025-08-19
- Results first posted
- 2025-08-19
- Limitations and caveats
Pharmacokinetic (PK) sampling from 0 to 8 hours after intravaginal administration of artesunate was not sufficient to capture the elimination phase of the drug and its metabolite. As a result, key plasma pharmacokinetic parameters including apparent clearance (CL/F), apparent volume of distribution (Vd/F), elimination half-life (t½), and area under the concentration-time curve from time zero to infinity (AUC₀-∞) could not be estimated.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin | Day 5 | To determine the area under the plasma concentration versus time curve (AUC) of dihydroartemisinin (DHA) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries). Mean DHA AUC will be submitted. |
| Secondary | To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Artesunate (AS) | Day 5 | To determine the area under the plasma concentration versus time curve (AUC) of Artesunate (AS) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries). Mean artesunate AUC will be submitted. |
| Secondary | To Determine the Maximum Concentration of Artesunate (AS) | Day 5 | To determine the maximum concentration of Artesunate (AS) (Cmax) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women. Mean artesunate Cmax (ng/ml) value will be submitted. |
| Secondary | To Determine the Maximum Concentration of Dihydroartemisinin (DHA) (Cmax) | Day 5 | To determine the maximum concentration of dihydroartemisinin (DHA) (Cmax) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women. Mean DHA Cmax (ng/ml) value will be submitted. |
| Secondary | To Determine the Time to Maximum Concentration (Tmax) of Artesunate (AS) Following Five Consecutive Days | Day 5 | To determine the time to maximum concentration (Tmax) of Artesunate (AS) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women. Mean DHA Tmax (hours) value will be submitted. |
| Secondary | To Determine the Time to Maximum Concentration (Tmax) of Dihydroartemisinin (DHA | Day 5 | To determine the time to maximum concentration (Tmax) of dihydroartemisinin (DHA) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women. Mean (Tmax) will be submitted. |
| Secondary | To Determine the Half-life (t1/2) of Artesunate (AS) | Day 5 | To determine the half-life (t1/2) of Artesunate (AS) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women. Mean Artesunate half-life (t1/2) (mins) will be submitted. |
| Secondary | To Determine the Half-life (t1/2) of Dihydroartemisinin (DHA) | Day 5 | To determine the half-life (t1/2) of dihydroartemisinin (DHA) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women. Mean DHA half-life (mins) will be submitted. |
| Secondary | To Determine the Apparent Clearance (CL/F) of Artesunate (AS) | Day 5 | To determine the apparent clearance (CL/F) of Artesunate (AS) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women. Mean Artesunate clearance (L/Kg/hr) will be submitted. |
| Secondary | To Determine the Apparent Clearance (CL/F) of Dihydroartemisinin (DHA) | Day 5 | To determine the apparent clearance (CL/F) of dihydroartemisinin (DHA) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women. Mean DHA clearance (L/Kg/hr) will be submitted. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin | Day 5 | ng/mL-h | MEAN | |
| SECONDARY | To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Artesunate (AS) | Day 5 | ng/mL-h | MEAN | |
| SECONDARY | To Determine the Maximum Concentration of Artesunate (AS) | Day 5 | ng/mL | MEAN | |
| SECONDARY | To Determine the Maximum Concentration of Dihydroartemisinin (DHA) (Cmax) | Day 5 | ng/mL | MEAN | |
| SECONDARY | To Determine the Time to Maximum Concentration (Tmax) of Artesunate (AS) Following Five Consecutive Days | Day 5 | hours | MEAN | |
| SECONDARY | To Determine the Time to Maximum Concentration (Tmax) of Dihydroartemisinin (DHA | Day 5 | hours | MEAN | |
| SECONDARY | To Determine the Half-life (t1/2) of Artesunate (AS) | Day 5 | The plasma half-life of Artesunate could not be estimated because the concentration versus time profiles did not reach an elimination phase (i.e., the concentration versus time profile did not decrease) from 0 to 8h post administration of intravaginal artesunate. | ||
| SECONDARY | To Determine the Half-life (t1/2) of Dihydroartemisinin (DHA) | Day 5 | The plasma half-life of dihydroartemisinin (DHA) could not be estimated because the concentration versus time profiles did not reach an elimination phase (i.e., the concentration versus time profile did not decrease) from 0 to 8h post administration. | ||
| SECONDARY | To Determine the Apparent Clearance (CL/F) of Artesunate (AS) | Day 5 | The plasma apparent clearance (CL/F) of Artesunate could not be estimated because the concentration versus time profiles of both forms did not reach an elimination phase (i.e., the concentration versus time profile did not decrease) from 0 to 8h post administration of intravaginal artesunate. | ||
| SECONDARY | To Determine the Apparent Clearance (CL/F) of Dihydroartemisinin (DHA) | Day 5 | The plasma apparent clearance (CL/F) of dihydroartemisinin (DHA) could not be estimated because the concentration versus time profiles of both forms did not reach an elimination phase (i.e., the concentration versus time profile did not decrease) from 0 to 8h post administration. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Dihydroartemisinin | Artesunate Vaginal Inserts/ Pessaries | 464.90 | Standard Deviation 228.70 | ng/mL-h | |
| To Determine the Area Under the Plasma Concentration Versus Time Curve (AUC) of Artesunate (AS) | Artesunate Vaginal Inserts/ Pessaries | 504.21 | Standard Deviation 281.11 | ng/mL-h | |
| To Determine the Maximum Concentration of Artesunate (AS) | Artesunate Vaginal Inserts/ Pessaries | 83.74 | Standard Deviation 42.73 | ng/mL | |
| To Determine the Maximum Concentration of Dihydroartemisinin (DHA) (Cmax) | Artesunate Vaginal Inserts/ Pessaries | 97.00 | Standard Deviation 53.12 | ng/mL | |
| To Determine the Time to Maximum Concentration (Tmax) of Artesunate (AS) Following Five Consecutive Days | Artesunate Vaginal Inserts/ Pessaries | 4.17 | Standard Deviation 1.59 | hours | |
| To Determine the Time to Maximum Concentration (Tmax) of Dihydroartemisinin (DHA | Artesunate Vaginal Inserts/ Pessaries | 6.33 | Standard Deviation 1.67 | hours | |
| Type, Frequency, Severity, and Duration of Adverse Events | Artesunate Vaginal Inserts/ Pessaries | abdominal pain Grade 1 | 3 | Participants | |
| Type, Frequency, Severity, and Duration of Adverse Events | Artesunate Vaginal Inserts/ Pessaries | vaginal discharge Grade 1 | 8 | Participants | |
| Type, Frequency, Severity, and Duration of Adverse Events | Artesunate Vaginal Inserts/ Pessaries | Toothache- Grade 1 | 1 | Participants | |
| Type, Frequency, Severity, and Duration of Adverse Events | Artesunate Vaginal Inserts/ Pessaries | vaginal fistula- Grade 2 | 1 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Artesunate Vaginal Inserts/ Pessaries | 12 | |
| Overall Study | COMPLETED | Artesunate Vaginal Inserts/ Pessaries | 12 | |
| Overall Study | NOT COMPLETED | Artesunate Vaginal Inserts/ Pessaries | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Abdominal Pain | Gastrointestinal disorders | Artesunate Vaginal Inserts/ Pessaries | 3 | 12 | |
| other | Vaginal discharge | Reproductive system and breast disorders | Artesunate Vaginal Inserts/ Pessaries | 8 | 12 | |
| other | Toothache | Gastrointestinal disorders | Artesunate Vaginal Inserts/ Pessaries | 1 | 12 | |
| other | Vaginal fistula | Reproductive system and breast disorders | Artesunate Vaginal Inserts/ Pessaries | 1 | 12 | |
| other | Pain in the extremity | Musculoskeletal and connective tissue disorders | Artesunate Vaginal Inserts/ Pessaries | 1 | 12 | |
| other | Vaginal pruritis | Reproductive system and breast disorders | Artesunate Vaginal Inserts/ Pessaries | 1 | 12 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Artesunate Vaginal Inserts/ Pessaries | 0 | 12 |
| Total, other adverse events | Artesunate Vaginal Inserts/ Pessaries | 8 | 12 |
| Total, serious adverse events | Artesunate Vaginal Inserts/ Pessaries | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K12HD103085 | Advancing womens reproductive health through research: the UNC WRHR Career Development Program | CHI, BENJAMIN H.; NEAL-PERRY, GENEVIEVE S. | UNIV OF NORTH CAROLINA CHAPEL HILL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2020 to 2025 |
Source NIH RePORTER
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.
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.
GET https://conductscience.org/api/trials/v1/NCT06263582
GET https://conductscience.org/api/trials/v1/NCT06263582/registered