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NCT02983110 · ClinicalTrials.gov registry record
Sex Hormone Therapy and Mucosal Tissues
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 12
- Enrollment target
NCT02983110: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT02983110 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02983110 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
Study Summary
The purpose of this research study is to better understand how sex hormone therapy that is used to treat women for menopausal symptoms, men with low testosterone, or as hormone therapy for transgender women, affects a class of medications called NRTIs (nucleoside reverse transcriptase inhibitors) used to treat and prevent HIV infection. The two most commonly used NRTIs are tenofovir and emtricitabine, which are the components of the drug Truvada and also included in the combination products Atripla, Complera, and Stribild. The medication's ability to work effectively may be altered when someone is also taking sex hormone therapy. In order to determine this effect, samples will be collected from some parts of the body where HIV makes copies. These samples will be measured for the levels of HIV medication, HIV virus and sex hormones that are present. The samples that will be looked at in this study include blood, cells from the vagina, semen, and tissue biopsies from the female genital tract and rectum.
Primary Outcome
(TFVdp/FTCtp)
Interventions
- PROCEDURE Phlebotomy
- PROCEDURE Anoscopy with Rectal Tissue Sampling
- PROCEDURE Female Genital Tract Sampling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-11 |
| Est. Completion | 2018-10-15 |
What the finished NCT02983110 record still lists
NCT02983110 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Phlebotomy is the first listed.
NCT02983110 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02983110 about?
NCT02983110 is a clinical study titled "Sex Hormone Therapy and Mucosal Tissues". The purpose of this research study is to better understand how sex hormone therapy that is used to treat women for menopausal symptoms, men with low testosterone, or as hormone therapy for transgender women, affects a class of medications called NRTIs (nucleoside reverse transcriptase inhibitors) us...
What is the current status of trial NCT02983110?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2016-11. Estimated completion is 2018-10-15.
What interventions are being tested in trial NCT02983110?
The interventions under investigation include: Phlebotomy (PROCEDURE), Anoscopy with Rectal Tissue Sampling (PROCEDURE), Female Genital Tract Sampling (PROCEDURE).
Who is sponsoring clinical trial NCT02983110?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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