Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT04283656
Eligibility Criteria:
Inclusion Criteria:
* Healthy self-identified transgender women (male-to-female) between 18-45 years old at the time of screening
* Have not undergone an orchiectomy
* Receiving oral estradiol and spironolactone for \>/= 3 months prior to study entry with a self-reported adherence to prescribed doses of \>/= 90%
* Agree to abstain from alcohol consumption throughout the duration of the study
* Be willing to briefly interrupt hormonal therapy prior to and during the study
* If on pre-exposure prophylaxis (PrEP) therapy containing tenofovir alafenamide or tenofovir disoproxil fumarate, willing to discontinue PrEP at least 2 weeks before study start and for the duration of the study
* Agree to use condoms for all sexual activity prior to the start and throughout the duration of the study
* Evidence of a personal signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
Exclusion Criteria:
* Presence of clinically significant acute or chronic disease, that in the investigator's opinion, would compromise the participant's safety during the study
* Use of injectable or transdermal estradiol
* Use of any other hormonal replacement therapy, wit h the exception of oral estradiol and spironolactone
* Current use of any antiretroviral drug. This will not be exclusionary if participants reported discontinuing within 30 days of screening
* Creatinine clearance \</= 60 mL/min, as estimated by the Cockcroft-Gault equation
* Known anaphylactic or severe systemic reactions to any components of doravirine, lamivudine, or tenofovir disoproxil fumarate
* Positive HIV, hepatitis B or Hepatitis C virus at screening. Evidence of prior hepatitis B infection and immunity is not exclusionary. Positive hepatitis C antibody with negative viral load or documented antiviral hepatitis C treatment with one post treatment non-detectable hepatitis C viral load is not exclusionary
* Recent significant blood or plasma donation
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04283656
Study Brief:
Protocol Section:
NCT04283656