MedTrace Logo

Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women

NCT04283656 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-03-26

Study results available
· View outcomes & findings →

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

  • Transgender Health
  • Gender Dysphoria
  • Transgender Women
  • Human Immunodeficiency Virus

Interventions

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

OTHER

Placebo

Placebo for one dose, daily

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Walter K Kraft, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-04
Primary Completion
2022-10-25
Completion
2022-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04283656 on ClinicalTrials.gov