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NCT06414408 · ClinicalTrials.gov registry record · Early Phase 1
Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP
A Early Phase 1 study of Sexually Transmitted Diseases, Bacterial, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT06414408: Recruiting Early Phase 1 study of Sexually Transmitted Diseases, Bacterial, sponsored by University of California, San Francisco.
NCT06414408 is a Early Phase 1 study of Sexually Transmitted Diseases, Bacterial that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 48 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06414408, a Early Phase 1 study of Sexually Transmitted Diseases, Bacterial, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
Rates of bacterial sexually transmitted infections (STIs) are rising globally, demanding innovative interventions beyond the scope of current efforts to prevent STIs. The United States Doxycycline Post-exposure Prophylaxis (DoxyPEP) Study has demonstrated the efficacy of doxycycline post-exposure prophylaxis (PEP) among men who have sex with men and transgender women; but puzzlingly, doxycycline PEP was found ineffective in cisgender women in the Kenyan doxycycline Post-Exposure Prophylaxis (dPEP) study, with preliminary data suggesting the low medication adherence may explain the null result. By study end, the investigators will have developed adherence measurement methods for doxycycline in hair, blood, and urine, and will use these techniques to help interpret the Kenyan dPEP study, and to examine the relative performance of these methods within the United States DoxyPEP trial, establishing adherence metrics for current and future rollout studies of doxycycline post-exposure prophylaxis
Primary Outcome
Doxycycline concentrations will be measured using liquid chromatography tandem mass spectrometry within hair samples for each of the four dosing patterns within an intensive washout pharmacokinetic phase following initial dosing.
Conditions Studied
Interventions
- DRUG Doxycycline Pill
Study Locations (1)
California
- University of California, San Francisco/San Francisco General Hospital - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2024-10-18 |
| Est. Completion | 2028-09-01 |
| Phase | Early Phase 1 |
What NCT06414408 shows while recruiting
NCT06414408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Sexually Transmitted Diseases, Bacterial appearing as the primary indexed condition, and to 1 intervention - of which Doxycycline Pill is the first listed.
NCT06414408 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06414408 about?
NCT06414408 is a clinical study titled "Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP". Rates of bacterial sexually transmitted infections (STIs) are rising globally, demanding innovative interventions beyond the scope of current efforts to prevent STIs. The United States Doxycycline Post-exposure Prophylaxis (DoxyPEP) Study has demonstrated the efficacy of doxycycline post-exposure pr...
What is the current status of trial NCT06414408?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 48 participants. The study started on 2024-10-18. Estimated completion is 2028-09-01.
What conditions does trial NCT06414408 study?
This clinical trial studies the following conditions: Sexually Transmitted Diseases, Bacterial.
What interventions are being tested in trial NCT06414408?
The interventions under investigation include: Doxycycline Pill (DRUG).
Who is sponsoring clinical trial NCT06414408?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06414408 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sexually Transmitted Diseases, Bacterial
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06414408's enrollment target sits among peer trials
48 541st of 2000 higher than 1,439 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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