Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CONRAD
With
International Partnership for Microbicides, Inc.
Gilead Sciences
Age
18–45
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Must be between 18-45 years old, inclusive
Must be in general good health by volunteer history without any clinically significant systemic disease (including liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease)
Must have regular menstrual cycles (minimum of 26 and maximum of 38 days)
Must be at least 2 months since last pregnancy outcome and have had at least two spontaneous menses
Must abstain from sexual activity and use of intravaginal products for 72 hours prior to the start of the single-dose phase and multi-dose phase, for at least one week following vaginal biopsies and for the duration of the study phases
Willingness to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol
You may not be if
Currently pregnant or at risk for pregnancy (may be using Paragard® IUD, effective barrier method, female sterilization or abstinence, or be sexually active with a vasectomized partner)
Currently breastfeeding or planning to breastfeed during the course of the study
Use of any hormonal contraceptives within 30 days of enrollment
Use of Depo-Provera within 120 days of enrollment History of abnormal Pap smear (by volunteer history) that has not been evaluated and treated, if indicated, according to standard guidelines
Current vaginal or urinary tract infection
Positive test for Neisseria gonorrhea or Chlamydia trachomatis at the time of screening
Positive wet mount for Trichomonas vaginalis at the time of screening or enrollment
Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection
Current or past use of any anti-retroviral therapies including but not limited to systemic tenofovir (Viread®)
Current or recent drug or alcohol abuse
Current or anticipated use of drugs on a daily basis that may reduce renal function (e.g. acyclovir or ibuprofen) or liver function (e.g. tylenol)
HIV positive at the time of screening
Hepatitis B surface antigen (HBsAg) positive at the time of screening
Grade 1 or higher serum chemistry or complete blood count abnormality in accordance with DAIDS toxicity table values
Abnormal finding on laboratory or physical examination or a medical condition which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data
Participation in any other research study in the 30 days prior to screening and/or plans to participate in any other research study during entire study duration
Clareo Health | Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel
