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

NCT02209519 | Completed Phase 3 Results

• 1 other identifier: 001
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Recurrent Bacterial Vaginosis

Keywords

bacterial vaginosis; recurrence; male partner

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to Recurrence of BV in Women Whose Partner Received Metronidazole Versus Females Whose Partners Did Not Receive Metronidazole

  from the end of week 1 up to 16 weeks

Study Arms (2)

Metronidazole

EXPERIMENTAL

Male Partner: metronidazole 500 mg PO BID x 7days Female Partner: metronidazole 500 mg PO BID x 7days

Drug: Metronidazole (male partner)

Placebo

PLACEBO COMPARATOR

Male Partner: one tablet PO BID for 7 days Female Partner: metronidazole 500 mg PO BID x 7days

Other: Placeob (male partner)

Interventions

Metronidazole (male partner) DRUG

500 mg PO BID for 7 days

Metronidazole

Placeob (male partner) OTHER

matching placebo capsules PO BID for 7 days

Placebo

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• At least 18 years of age (19 years of age in Alabama due to State law)
• Sexual partner to a female who meets study eligibility
• Willingness to provide informed consent
• Willingness to abstain from sexual intercourse or use condoms {during the study}
• Willingness to abstain from alcohol for the first week of the study
• At least 18 years of age (19 years of age in Alabama due to State law)
• Heterosexual with a regular partner
• History of 2 or more episodes of BV in the previous 12 months
• Symptoms of BV including vaginal discharge and/or odor
• Positive Amsel criteria for BV including vaginal pH \>4.5, positive whiff test, presence of clue cells
• Willingness to provide informed consent
• Willingness to abstain from sexual intercourse or use condoms {during the study}
• Willingness to abstain from alcohol for the first week of the study

You may not qualify if:

• Allergy to metronidazole
• Failure of the male partner to keep his appointment to be seen within 48 hours
• Pregnant or breast feeding (females)
• HIV or other chronic disease which in the opinion of the investigator would interfere with the ability to participate in this study
• Subject requires concurrent lithium, coumadin, dilantin, or antabuse
• Presence of trichomonas on wet prep of vaginal fluid (females)
• Women with a history of recurrent BV for \>3 years or women who have failed previous treatment studies for BV

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Wayne State University: collaborator

Study Sites (1)

Jane Schwebke

Pell City, Alabama, 35128, United States

Location

Related Publications (1)

• Schwebke JR, Lensing SY, Lee J, Muzny CA, Pontius A, Woznicki N, Aguin T, Sobel JD. Treatment of Male Sexual Partners of Women With Bacterial Vaginosis: A Randomized, Double-Blind, Placebo-Controlled Trial. Clin Infect Dis. 2021 Aug 2;73(3):e672-e679. doi: 10.1093/cid/ciaa1903.

  PMID: 33383580 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial; Recurrence

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jane Schwebke, MD
• Organization: University of Alabama at Birmingham

jschwebk@uabmc.edu

205-975-5665

Study Officials

• jane Schwebke, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 6, 2014
• Study Start: February 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 27, 2020
• Results First Posted: April 27, 2020

Record last verified: 2020-04

Locations

US (1)