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

Recurrent Bacterial Vaginosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209519
• Other study ID #: 001
• Status: Completed
• Phase: Phase 3
• Start date: February 2015
• Est. completion date: March 2019

Study information

• Verified date: April 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This study will be performed as a phase III randomized, double-blinded trial to evaluate the efficacy of 1) metronidazole 500 mg PO BID for 7 days versus 2) placebo capsules alone for treatment of the male sexual partner of women with recurrent BV. The primary outcome is the rates of recurrent BV between these two groups. Although this is a phase III study we will carefully monitor potential toxicity in the males since it is currently not standard of care to treat males for this indication.

Women with symptomatic BV defined by Amsel criteria 1 and no evidence of STD will be invited to participate. Inclusion criteria are that the woman be at least 18 years of age, heterosexual, have symptoms of vaginal odor and/or discharge, meet the modified clinical (Amsel) criteria for BV (all must have a vaginal pH of >4.5, a positive whiff test, and clue cells to be eligible), have an enrollment Nugent score of 7 or greater, and a history of 2 or more episodes of BV in the previous year. She must have a regular current sex partner who would be willing to participate. We will exclude women who have had recurrent BV for greater than 3 years as well as women who have failed previous treatment studies since it is likely that these women are having recurrent BV as a result of relapse of the BV biofilm as opposed to reinfection.

Follow-up visits will be conducted at day 21, 8 and 16 weeks. At each follow-up visit, a questionnaire will be administered, diary reviewed, pelvic examination conducted and specimens (Gram stain, Amsel criteria, G vaginalis culture and detection of novel organisms) obtained as done at the enrollment visit. Participants will be asked to return the medication packages, a standard way of assessing adherence to the regimen. Cure will be ascertained using the clinical criteria for BV of Amsel 1 as well as the Nugent scoring system 16. The persistence or disappearance of specific organisms will be analyzed in relationship to these standard definitions of cure. Women who fail initial therapy or have recurrence of symptomatic BV during the course of the study will be re-treated with 7 days of metronidazole and dropped from the study at that time. Any woman found to have a positive screening test for gonorrhea or chlamydia will be treated appropriately and instructed to notify her partner of the need to be treated. Women with intercurrent vaginal yeast infections, which may occur, will be treated with oral fluconazole and continued in the study. Women with a positive culture for trichomonas will be dropped from the study as their male partners will require treatment with metronidazole.

Male Study Procedures

Males referred by their female sexual partner will be seen within 48 hours of enrollment of the female. Males will be consented and asked behavioral and historical questions using a gender appropriate questionnaire, with special emphasis on number of current sexual partners. A couple verification screening tool will be utilized to be certain they are current sexual partners48. The confidentiality of their answers will be emphasized. They will be examined and a urethral swab specimen obtained to be used for G vaginalis culture and then archived. Following the swabs, two external swabs from the coronal sulcus and a 10 ml first void urine specimen will be obtained. These specimens will also be used for G vaginalis culture and archived for possible use in detection of novel organisms. The urine will also be used for NAATS for N gonorrhoeae and C trachomatis and for the determining the presence or absence of Gardnerella biofilm24. They will then be randomized to one of two treatment arms:

1. Metronidazole 500 mg PO twice a day for 7 days .

2. Placebo capsules PO twice a day for 7 days.

Both arms will also contain an instruction sheet on metronidazole.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Recurrent Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Metronidazole (male partner)
500 mg PO BID for 7 days

Other:
• Placeob (male partner)
matching placebo capsules PO BID for 7 days

Locations

Country	Name	City	State
United States	Jane Schwebke	Pell City	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Female Partners Whose Male Partners Received Metronidazole Versus Females Whose Male Partners Did Not Receive Metrodiazole With Recurrence of BV in the Female	the female partners will be assessed for recurrence/persistence of BV. tRecurrence/persistence is measured by - Positive 3 - 4 Amsel criteria (vaginal pH > 4.7, clue cells, positive whiff test, homogenous discharge); Nugent score >3; No Recurrence/Persistence is measured by: - Presence of 0 -2 Amsel criteria; Nugent score 0-3.	16 weeks post start of receipt of study drug
Secondary	Time to Recurrence of BV in Women Whose Partner Received Metronidazole Versus Females Whose Partners Did Not Receive Metronidazole	time to recurrence measured in days	from the end of week 1 up to 16 weeks