common.study.topics.clinical

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

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

Pharmaceutical medication involved common.study.methods.has-drugs-yes
Patients and healthy individuals accepted 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