Randomised controlled trial of the oral contraceptive pill use to reduce bacterial vaginosis (BV) recurrence following recommended antibiotic therapy

Phase 2

• Conditions: Bacterial vaginosis; Infection - Sexually transmitted infections

• Registration Number: ACTRN12613001147774
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 314

Inclusion Criteria

Women will be eligible if they:
i) Are 18-45 years of age,
ii) Are symptomatic with BV, defined as a Nugent score of 4-10 and 3-4 Amsel criteria,

Exclusion Criteria

Women will be ineligible if they are:
i) concurrently diagnosed with pelvic inflammatory disease (PID)
ii) confirmed to be pregnant at the time of recruitment, or wish to conceive within the next 6 months,
iii) known to be HIV positive,
iv) unwilling or unable to comply with the requirements of the study protocol,
v) already currently using a hormonal method of contraception,
vi) known to have contraindications to OCP according to WHO criteria (e.g. focal migraine, history of deep venous thrombosis [DVT], hypertension etc)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of BV defined as 3-4/4 Amsel criteria and a Nugent score of 4-10. <br>[within 6 months of randomisation]

Secondary Outcome Measures

Name	Time	Method
Recurrence of BV defined by Amsel method (3-4/4 Amsel criteria) and Nugent score 4-10[within 3 months of randomisation];Recurrence of BV defined by Nugent score 7-10[at 1 month, and within 3 and 6 months, of randomisation]