Development of a standard method for measurement of azithromycin concentration in vaginal cellular material – a pilot study

Phase 4

Completed

• Conditions: genital chlamydia infection; Infection - Sexually transmitted infections

• Registration Number: ACTRN12616001684415
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1 Women aged 18 years and older
2 Must have adequate English and comprehension skills to give informed consent.
3 Able to attend the clinic at regular intervals during the study to collect and drop of specimens.

Exclusion Criteria

1 Pregnant women
2 Women currently menstruating
3 Women on medication likely to significantly interact with Azithromycin eg. Cyclosporin, digoxin
4 Women known to have any allergies associated with macrolides (very rare).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal tissue concentrations of azithromycin (mcg/g) post-dose using self-collected vaginal swabs and measured with liquid-chromatography tandem-mass spectrometry[Baseline (pre-dose), 1/2 hourly for up to 5 hours, 24 hours and then daily up to 9-days post-dose]

Secondary Outcome Measures

Name	Time	Method
Blood concentrations of azithromycin (mcg/ml) post-dose measured with liquid-chromatography tandem-mass spectrometry[4 hours post-dose]