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NCT04283656 · ClinicalTrials.gov registry record · Phase 1
Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women
A Phase 1 study of Human Immunodeficiency Virus and Gender Dysphoria, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT04283656 is a Phase 1 study of Human Immunodeficiency Virus and Gender Dysphoria that has completed, run by Thomas Jefferson University. The registered enrollment target is 8 participants, below the 184-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04283656, a Phase 1 study of Human Immunodeficiency Virus and Gender Dysphoria, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Transgender women living with Human Immunodeficiency Virus (HIV) may prioritize gender-affirming hormonal therapy over antiretroviral drug therapy. Hormonal therapy typically consists of oral estradiol and spironolactone, which induce drug-metabolizing enzymes after prolonged administration. This study evaluates the bi-directional potential drug interaction between the antiretroviral drug, doravirine, when co-administered with estradiol and spironolactone.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Doravirine/Lamivudine/Tenofovir
- DRUG Spironolactone 100mg
- DRUG Estradiol 2mg
Study Locations (1)
Pennsylvania
- Clinical Research Unit at Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-01-04 |
| Est. Completion | 2022-12-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04283656
The ClinicalTrials.gov registry entry for NCT04283656 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 184-participant average among 39 other Human Immunodeficiency Virus trials with a reported enrollment target (96% lower). The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Human Immunodeficiency Virus appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04283656 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04283656 about?
NCT04283656 is a clinical study titled "Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women". Transgender women living with Human Immunodeficiency Virus (HIV) may prioritize gender-affirming hormonal therapy over antiretroviral drug therapy. Hormonal therapy typically consists of oral estradiol and spironolactone, which induce drug-metabolizing enzymes after prolonged administration. This st...
What is the current status of trial NCT04283656?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2022-01-04. Estimated completion is 2022-12-30.
What conditions does trial NCT04283656 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus, Gender Dysphoria, Transgender Women, Transgender Health.
What interventions are being tested in trial NCT04283656?
The interventions under investigation include: Placebo (OTHER), Doravirine/Lamivudine/Tenofovir (DRUG), Spironolactone 100mg (DRUG), Estradiol 2mg (DRUG).
Who is sponsoring clinical trial NCT04283656?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04283656 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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