CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 641 enrolled
Drug / intervention
Doxycycline Hyclate Delayed-Release 200 mgdrug
Likely dose
Doxycycline Hyclate Delayed-Release 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03980223
NCT03980223Phase 4Completed

Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men

University of California, San Francisco·interventional·Posted Jun 10, 2019·Updated Jul 12, 2024

In Brief

A Phase 4 clinical trial evaluating Doxycycline Hyclate Delayed-Release 200 mg for Gonorrhea and 2 related conditions. Completed, enrolled 641 participants across 3 sites.

Detailed Summary

The purpose of this study is to understand if taking an antibiotic called doxycycline by mouth as soon as possible after sexual contact without a condom can reduce the risk of sexually transmitted infections (STIs), including gonorrhea, chlamydia and syphilis. The study will also look at the safety of doxycycline PEP and the impact that PEP may have on the bacteria that cause STIs as well as on bacteria that normally live on the body. While doxycycline is approved by the Food and Drug Administration (FDA), taking doxycycline immediately after sexual contact to prevent infection is investigational and is not approved by the FDA for this use. Participants will take part in the study for 1 year.

Study Details

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJun 10, 2019
Enrollment StartNov 26, 2019
Primary CompletionJun 12, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.1 years ago

Interventions

Doxycycline Hyclate Delayed-Release 200 mgdrug

200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP)