An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina

An Imaging Trial of the Distribution of Topical Gel Formulations in the Human Vagina: Candidate Formulations

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00214747

Enrollment

Registered

2005-09-22

Start date

2005-03-31

Completion date

2005-11-30

Last updated

2005-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV Seronegativity, HIV

Brief summary

This study is designed to assess the distribution and spread of four different vehicle formulations in the vagina. In-vivo data will be obtained regarding each vehicle formulation at various time points after insertion of the gel into the vagina.

Interventions

DRUGVehicle gel formulations

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* 18 to 45 year old women * non-pregnant * healthy

Exclusion criteria

* abnormal finding on pelvic exam * pregnant or breastfeeding * allergy to intravaginal products * history of claustrophobia

Design outcomes

Primary

Measure	Time frame
MRI evaluation of gel formulation distribution in vagina	—
Total linear distance in mm covered by gel	—
Surface area actually covered by gel (mm)	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026