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Completed Phase 4 Interventional Results available

Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM

ClinicalTrials.gov ID: NCT03608774

Public ClinicalTrials.gov record NCT03608774. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 3:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 4, Randomized, Double-Blinded, Placebo-Controlled Trial of Azithromycin Versus Doxycycline for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

A clinical trial to compare the efficacy of azithromycin (Arm 1) vs. doxycycline (Arm 2) administered per CDC's STD Treatment Guidelines for rectal Chlamydia trachomatis (CT) in men who have sex with men (MSM). Subjects will be males aged = / \> 18 years with a microbiologically confirmed diagnosis of rectal CT and at least one male sex partner in the past 12 months. The trial will be conducted at two sites in the US and will enroll up to 274 total subjects to achieve 246 subjects who contribute to the primary analysis. The duration of this study will be approximately 16 months 22 months with subject participation duration 29 days. The primary objective of this study is to compare the efficacy of azithromycin vs. doxycycline for treatment of rectal CT infection in MSM based on microbiologic cure (negative NAAT) at Day 29.

Study identification

NCT ID
NCT03608774
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
177 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 99 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 12, 2018
Primary completion
Feb 20, 2020
Completion
Feb 20, 2020
Last update posted
Jan 6, 2021

2018 – 2020

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Fenway Health - The Fenway Institute Boston Massachusetts 02115
University of Washington - Harborview Medical Center - Center for AIDS and STD Seattle Washington 98104-2499

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03608774, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 6, 2021 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03608774 live on ClinicalTrials.gov.

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