Daily doxycycline levels measured to fight STIs
NCT ID NCT06545656
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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24 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Apr 2025
- Lead sponsor
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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
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18 to 59 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Hope Clinic
Atlanta, Georgia, 30322, United States
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Other studies related to the condition(s) this trial covers.
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