Recruiting
Phase 1

Topical Gel

Sponsor:

Biosyn

Code:

NCT00214812

Conditions

HIV Infections

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

HEC placebo gel

Study Details

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.

Conditions

HIV Infections

Study ID

NCT00214812

Start date

Jun, 2005

Status verified date

Sep, 2005

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

6 participants

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

HEC placebo gel

Primary outcome measure

  • Presence or absence of bare spots with and without Gd. [ Time Frame: undefined ]
  • Quantification and location of bare spots. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Kurt Barnhart, MD

215 662 2974

Locations

Reproductive Research Unit, U of Penn Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Kurt Barnhart, MD

215-662-2974

More Information

Sponsor

Biosyn

Last update posted

Oct 25, 2005

Last verified

Sep, 2005

Keywords

  • HIV Seronegativity
  • HIV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Biosyn on 2005-10-25.