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Non-nucleoside Reverse Transcriptase Inhibitor

Period I for Gender Dysphoria (IDENTIFY Trial)

Phase 1
Waitlist Available
Led By Walter K Kraft, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
Awards & highlights

IDENTIFY Trial Summary

This trial found that estradiol and spironolactone may decrease the concentration of doravirine, which is used to treat HIV.

Eligible Conditions
  • Gender Dysphoria
  • Transgender Health
  • Transgender Women
  • HIV/AIDS

IDENTIFY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 0.5, 1, 2, 6, 12, 24, 48, 72, 96 hours post-dose for all participants for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Doravirine area under the plasma concentration versus time curve from 0 hours to infinity (AUC0-∞)
Doravirine maximum concentration (Cmax)
Doravirine trough concentration (C24)
+6 more

IDENTIFY Trial Design

3Treatment groups
Experimental Treatment
Group I: Period IIIExperimental Treatment3 Interventions
Sequence E, Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone Sequence F, Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone
Group II: Period IIExperimental Treatment3 Interventions
Sequence E and F, Treatment B: Single-dose estradiol and spironolactone co-administered with placebo
Group III: Period IExperimental Treatment3 Interventions
Sequence E, Treatment A: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate alone Sequence F, Treatment C: Single-dose oral Doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol 2mg
2022
Completed Phase 1
~10
Spironolactone 100mg
2022
Completed Phase 4
~110
Doravirine/Lamivudine/Tenofovir
2022
Completed Phase 1
~10

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
444 Previous Clinical Trials
145,617 Total Patients Enrolled
Walter K Kraft, MDPrincipal InvestigatorThomas Jefferson University
8 Previous Clinical Trials
115 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is eligibility for this clinical experiment open?

"This clinical trial is searching for 12 volunteers, aged between 18 and 45, who suffer from gender dysphoria. Essential criteria include: willingness to suspend Prep (containing tenofovir alafenamide or tenofovir disoproxil fumarate) 2 weeks before start date and throughout the study; no prior orchiectomy; abstinence from alcohol consumption during the duration of the study; brief interruption of hormonal therapy pre-study and during study period; use condoms for all sexual activity both preceding commencement of research until its completion."

Answered by AI

What is the enrollment limit for this research project?

"No, this trial is no longer actively seeking applicants. First posted on February 14th 2022 and last edited on October 18th 2022, alternative studies may now be explored; 646 trials are currently recruiting for gender dysphoria treatments and 168 for the same therapy presently search for participants."

Answered by AI

Is there ongoing recruitment for this experiment?

"This clinical trial is no longer seeking participants, and it was last updated on October 18th of 2022. According to information found on clinicaltrials.gov, there are 814 other studies that are currently recruiting patients for their research initiatives."

Answered by AI

What maladies is this therapeutic modality commonly prescribed for?

"Generally, this treatment is used to ameliorate secondary hyperaldosteronism. It has also been known to help manage pharmacotherapy, nephrotic syndrome and breast-related ailments."

Answered by AI

Have other investigations explored the effects of this remedy?

"Currently, 168 trials are investigating this therapeutic intervention. Of those studies, 50 have reached Phase 3 of the clinical trial process. While Boylston is the primary hub for these type of experiments in Massachusetts, there are over 2400 other locations running related research."

Answered by AI

Is the eligibility for this experiment restricted to individuals aged 20 and above?

"In order to be eligible for this study, applicants must lie between 18 and 45 years old. Conversely, there are 183 clinical trials available for minors under the age of 18 and 574 studies with inclusion criteria restricted to individuals over 65."

Answered by AI

What hazards could be associated with this particular treatment plan?

"As this is a Phase 1 trial, which entails limited data regarding efficacy and safety, our team at Power gauges the treatment's security level to be a 1."

Answered by AI
~2 spots leftby Apr 2025