None listed
Conditions
Brief summary
OVERALL AIM: This pilot study aims to determine the feasibility and acceptability of treatment of male partners of women with bacterial vaginosis (BV). OTHER AIMS: To examine the impact of dual partner treatment (male and female treatment) for BV on BV-associated bacteria on the male and female genitalia for 1 month after treatment. BACKGROUND AND SIGNIFICANCE: BV is the most common cause 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, low birth weight, pelvic infection, and increased risk of HIV and sexually transmitted infections. We have shown that BV recurrence (getting the infection back again) in women is common even after they take the recommended antibiotic treatment. A number of investigators have shown that BV-associated bacteria (BVAB) are present in male partners of women with BV on the penile skin and also at the end of the urethra (the tube you pee through), but male partner treatment is not currently recommended by current treatment guidelines. Studies of recurrent BV indicate that reinfection from sexual partners may be contributing to the high rates of recurrence but this requires more evaluation. Metronidazole and topical clindamycin are both antibiotics approved for use in Australia to treat BV in women. As BV has not previously been thought to affect men they have not been licensed for use to treat BV in men. Metronidazole is however a commonly used antibiotic in men and women and has been approved for use for many conditions affecting men and women, including gastroenteritis, abscesses, dental infections and types of pneumonia, to list a few. There is extensive experience in using it in men for these other conditions. Topical clindamycin cream has not been approved for use for any conditions in men; however men may get exposed to the cream if they are having sexual intercourse with their partner while she is using the cream to treat BV. Clindamycin cream and oral metronidazole are therefore considered is an experimental treatment for BV in men. This means that they are being tested to see if they are an effective treatment to get rid of BV-associated bacteria in men.
Interventions
Women with BV received standard treatment for their bacterial vaginosis (oral metronidazole 400 mg twice daily for seven days or 2% vaginal clindamycin cream as one applicator vaginally for seven nights if metronidazole was contraindicated or declined).
Male partners received oral metronidazole 400mg twice daily and 2% clindamycin cream applied topically to the head of the penis and upper shaft (under the foreskin if uncircumcised) twice daily for seven days.
Adherence and side effects to trea
Women with BV received standard treatment for their bacterial vaginosis (oral metronidazole 400 mg twice daily for seven days or 2% vaginal clindamycin cream as one applicator vaginally for seven nights if metronidazole was contraindicated or declined). Male partners received oral metronidazole 400mg twice daily and 2% clindamycin cream applied topically to the head of the penis and upper shaft (under the foreskin if uncircumcised) twice daily for seven days. Adherence and side effects to treatment were self-reported by participants in a questionnaire on day 8 at the end of the treatment period.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women are eligible if they: i) Are 18-55 years of age, ii) Have symptomatic BV (defined as a Nugent score of 4-10 and 3-4 Amsel criteria) and being treated with either oral metronidazole 400 mg twice daily for seven days or 2% vaginal clindamycin cream as one applicator vaginally for seven nights if metronidazole was contraindicated or declined. iii) Have a single regular male partner who was willing to be enrolled in the trial. iv) they were willing and able to comply with the protocol requirements v) they are willing and able to comply with the protocol requirements Males are eligible if: i) their female partner meets the eligibility criteria ii) they are willing and able to comply with the protocol requirements
Exclusion criteria
Women will be ineligible if they are: i) known to be HIV positive, ii) pregnant or breastfeeding, iii) concurrently diagnosed with pelvic inflammatory disease (PID) iv) allergic to study medication v) had other concurrent sexual partners Males will be ineligible if they are: i) HIV positive ii) allergic to metronidazole and/or clindamycin iii) had other concurrent sexual partners
Outcome results
None listed