An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00214812

Enrollment

Registered

2005-09-22

Start date

2005-06-30

Completion date

Unknown

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 will assess the distribution of a microbicidal gel in the vagina and confirm the presence of bare spots. MRIs will be done with and without the addition of the MRI contrast Gadolinium to the microbicide in order to determine whether the bare spots are an artifact of the MRI technique.

Interventions

DRUGHEC placebo gel

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* 18 -45 year old women * normal Pap smear * not pregnant

Exclusion criteria

* abnormal pelvic exam * history of claustrophobia * allergy to product formulation * pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
Presence or absence of bare spots with and without Gd.	—
Quantification and location of bare spots.	—

Countries

United States

Contacts

Primary ContactKurt Barnhart, MD

215 662 2974

Outcome results

None listed

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