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

Biosyn6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

HIV Infections

Interventions

HEC placebo gelDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Reproductive Research Unit, U of Penn Medical Center

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Presence or absence of bare spots with and without Gd.

Quantification and location of bare spots.

Central Contacts

Kurt Barnhart, MD

CONTACT

215 662 2974

Data from ClinicalTrials.gov

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