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

biosyn Arzneimittel

Status and phase: Unknown; Phase 1

Conditions: HIV Infections

Treatments: Drug: HEC placebo gel

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00214812

RRU-005

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind