None listed
Conditions
Brief summary
OVERALL AIM: This randomised controlled trial is aiming to establish if women who take the oral contraceptive pill (OCP) have a lower risk of getting bacterial vaginosis back again (called BV relapse or recurrence) after routine recommended antibiotic treatment. OTHER AIMs: we also aim to determine the mechanisms, or reasons, as to how using the OCP may be reducing women’s risk of getting BV back again. This will involve exploring the effects of oral contraception on healthy vaginal bacteria and BV-associated bacteria, and the effects on natural vaginal sugars and acids and immune markers. BACKGROUND AND SIGNIFICANCE: Bacterial vaginosis is the commonest causes of abnormal vaginal discharge in women of reproductive age affecting between 12-30% of women, suggesting it may currently affect at least 1 million Australian women. It can be associated with important complications such as miscarriage, premature birth and low birth weight, pelvic infection, and increased susceptibility to HIV and sexually transmitted infections (STIs). We have shown that BV relapse is common even after recommended treatment. However, we have found in two studies that women using combined (oestrogen & progesterone containing) hormonal contraception appeared to have half the risk of BV recurrence following recommended antibiotics compared to women not taking the pill. We further confirmed this finding by meta-analysis of published literature in which we showed that in 55 studies, women using hormonal contraception had a reduced risk of BV recurrence. However, no randomised controlled trials have been conducted and how hormonal contraception reduces a women’s risk of BV is unknown. We hypothesise that this could be happening via different mechanisms/actions such as increasing the levels of natural vaginal acids and by altering the vaginal immune response which may cause normally occurring “healthy” vaginal bacteria to increase and for less healthy BV-associated bacteria to decrease. HOW WILL WE DO THIS: This is a trial of 314 women who have been diagnosed with BV and prescribed the standard antibiotic treatment. Half of the participants (157 women) will be randomised to the oral contraceptive pill for 6 months, and the other half to no OCP for 6 months. We anticipate that those who take the pill will have a reduced risk of getting BV back again but this remains to be proven in this trial.
Interventions
This is a randomised controlled open-label trial of the oral contraceptive pill for prevention of BV recurrence following recommended antibiotic therapy. All participants in this trial will be given current recommended antibiotic treatment for BV, in keeping with standard of care, prior to being assessed for eligibility for the trial. This antibiotic will predominantly be metronidazole orally 400 mg twice a day for 7 days, however, clinicians will be able to prescribe a 7-day regimen of oral or
This is a randomised controlled open-label trial of the oral contraceptive pill for prevention of BV recurrence following recommended antibiotic therapy. All participants in this trial will be given current recommended antibiotic treatment for BV, in keeping with standard of care, prior to being assessed for eligibility for the trial. This antibiotic will predominantly be metronidazole orally 400 mg twice a day for 7 days, however, clinicians will be able to prescribe a 7-day regimen of oral or vaginal clindamycin, which has equivalent efficacy, if patients are unable to tolerate metronidazole or it is contraindicated. Intervention: Arm one: Combined oestrogen and progesterone containing oral contraceptive pill (OCP) commencing on day 8 and administered for six months. Randomisation will be occurring for the OCP which will be a standard monophasic 30mcg ethinyl oestradiol pill with 150 mcg of levonorgesterol, unless otherwise clinically indicated, or preferred by the participant or clinician. It will be prescribed in the standard 21 day active, 7 day placebo pill regimen. Adherence to the OCP will be monitored by monthly self-report within questionnaires.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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)
Outcome results
None listed