Drug Interactions in Transgendered Women
common.study.values.description
“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 study evaluates the bi-directional potential drug interaction between the antiretroviral drug, doravirine, when co-administered with estradiol and spironolactone.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
participant.ui.study.affiliations-map.online-study.text
common.study.values.methods
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
Drug - Doravirine/Lamivudine/Tenofovir
100mg/300mg/300mg orally for one dose, daily
Drug - Spironolactone 100mg
200mg orally for two doses, twice-daily
Drug - Estradiol 2mg
4mg orally for two doses, twice-daily
Placebo
Placebo for one dose, daily
participant.views.study.view.additional
participant.views.study.view.scientific-title
A Prospective, Randomized, Three-period Crossover, Interaction Study to Evaluate the Pharmacokinetics of Doravirine and Tenofovir Disoproxil Fumarate Co-administered With Cross-sex Hormonal Therapy in Adult HIV-negative Transgender Women
common.study.values.clinical-trial-id
NCT04283656
participant.views.study.view.id
b4x5gb
