Overview

Randomized Controlled Trial of Treatment of Male Partners of Women With BV

Status:
Completed
Trial end date:
2019-03-01
Target enrollment:
0
Participant gender:
All
Summary
Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with metronidazole or placebo to compare the rates of recurrent BV in the women
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborator:
Wayne State University
Treatments:
Metronidazole
Criteria
Inclusion Criteria: Female

1. At least 18 years of age (19 years of age in Alabama due to State law)

2. Sexual partner to a female who meets study eligibility

3. Willingness to provide informed consent

4. Willingness to abstain from sexual intercourse or use condoms {during the study}

5. Willingness to abstain from alcohol for the first week of the study

Inclusion Criteria: Male

1. At least 18 years of age (19 years of age in Alabama due to State law)

2. Heterosexual with a regular partner

3. History of 2 or more episodes of BV in the previous 12 months

4. Symptoms of BV including vaginal discharge and/or odor

5. Positive Amsel criteria for BV including vaginal pH >4.5, positive whiff test,
presence of clue cells

6. Willingness to provide informed consent

7. Willingness to abstain from sexual intercourse or use condoms {during the study}

8. Willingness to abstain from alcohol for the first week of the study

Exclusion criteria (both genders)

1. Allergy to metronidazole

2. Failure of the male partner to keep his appointment to be seen within 48 hours

3. Pregnant or breast feeding (females)

4. HIV or other chronic disease which in the opinion of the investigator would interfere
with the ability to participate in this study

5. Subject requires concurrent lithium, coumadin, dilantin, or antabuse

6. Presence of trichomonas on wet prep of vaginal fluid (females)

7. Women with a history of recurrent BV for >3 years or women who have failed previous
treatment studies for BV