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Quantification of Estradiol's Impact in Different Cellular Populations of the Lower Gastrointestinal Tract

University of North Carolina at Chapel Hill


Description

In this study, we want to explore the effect of the hormone estradiol on blood, cellular and tissue concentrations of Truvada. We will also be assessing if cells can be used as a surrogate for move invasive tissue sampling in the future.


Keywords:

HIV/AIDS, Women's Health


Category:

Procedures

Qualifications

 


Age
18 - 49 years


Gender
Female


Study Population

10 healthy cisgender female volunteers between 28-49 years able to dose with study medication for 10 days and on two sampling visits provide blood, tissue and cell samples


Investigator

Mackenzie Cottrell
Research Assistant Professor
UNC Eshelman School of Pharmacy-Division of Pharmacotherapy and Experimental Therapeutics

For questions, contact:

Heather Asher Prince
princeH@med.unc.edu
(919) 962-5344


Recruitment Period End

October 31, 2019

Location

Primary Location
Clinical and Translational Research Center
Burnett-Womack Building, 160 Dental Cir, Chapel Hill, NC 27514, USA

Study Qualifications

Gender Female

Age Range 18 - 49 years

Participant qualification(s) .Healthy cisgender female between 18-49years with no significant surgical alteration of the genital or gastrointestinal tract .Regular menstrual periods .Negative for sexually transmitted infections .Able to swallow pills .On at least one form of acceptable birth control, unless in a monogamous same-sex relationship

Not eligible if: • Are younger than 18 years of age or older than 49 years of age • Are HIV infected, Hepatitis B or C, or have other sexually transmitted infections • Donated blood recently • Have had a rectal biopsy in the last 6 months • Are pregnant, possibly pregnant, or lactating • Irregular or absent menses • Are not able to swallow pills • Unwilling to use at least one form of effective contraception during the entire study period. Examples of acceptable forms of birth control, but not limited to, are: • Non-continuous systemic hormonal contraceptive (oral, depot, transdermal or implant) • Non-hormonal IUD placed at least 1 month prior to study enrollment • Bilateral tubal ligation (Sterilization) • Vasectomized male partners • Condom + Spermicide • Same sex partners • Abstinence of at least 3 months, with no plan to become sexually active during the study period • Any condition, which, in the opinion of the investigator, is likely to interfere with follow-up or ability to take the study medication appropriately.

Number of Visits

    » 5 In person visit(s)

    All in our clinic. Screening, Follow Up and 2 sampling visits

    » 9 Remote visit(s)

    9 Skype visits to observe dosing

Participation Period

2 months

Compensation

$565 Visa gift card, paid at first and last visit

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.