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Daily doxycycline levels measured to fight STIs

NCT ID NCT06545656

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how much doxycycline builds up in body tissues after taking it daily for 7 days. Researchers measured levels in rectal and vaginal tissues to help design better ways to prevent bacterial sexually transmitted infections (STIs). 24 healthy adults took part, including people assigned male or female at birth.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

24 people

The number who actually took part.

Started

Sep 2024

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 59 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Assigned male sex or female sex at birth * In good general health * Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study * For HIV positive people, on stable antiretroviral therapy with an undetectable viral load and cluster of differentiation 4 (CD4) count\> 300ul/ml * Willing to use condoms consistently for the duration of the study * Able to provide informed consent * No plans for relocation in the next 4 months * Not pregnant and does not plan on getting pregnant for the duration of the study * Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure * Willing to use study products as directed Exclusion Criteria: * Current or chronic history of liver disease * Continued need for, or use during the 90 days prior to enrollment, of the following medications: * Systemic immunomodulatory agents * Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators) * Chemotherapy or radiation for treatment of malignancy * Experimental medications, vaccines, or biologicals * Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures * Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements * Known allergic reaction to study drugs * Significant laboratory abnormalities at baseline visit for rectal biopsies, including but not limited to: * Hemoglobin (Hgb) ≤ 10 g/dL * Partial thromboplastin time (PTT) \> 1.5x upper limit of normal (ULN) or international normalised ratio (INR) \> 1.5x ULN * Platelet count \<100,000

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hope Clinic

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.