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

biosyn Arzneimittel

Status and phase: Unknown; Phase 1

Conditions: HIV Infections

Treatments: Drug: Vehicle gel formulations

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00214747

RRU-003

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind