Who is sponsoring NCT02209519?

NCT02209519 is sponsored by University of Alabama at Birmingham.

What condition does NCT02209519 study?

NCT02209519 studies Recurrent Bacterial Vaginosis.

What drugs are being tested in NCT02209519?

Interventions: Metronidazole (male partner), Placeob (male partner).

What is the status of NCT02209519?

NCT02209519 is currently COMPLETED.

Last reviewed 2020-04-24 · How we verify

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

NCT02209519 Phase 3 COMPLETED Results posted

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

Details

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 3
Status	COMPLETED
Enrolment	214
Start date	2015-02
Completion	2019-03

Conditions

Recurrent Bacterial Vaginosis

Interventions

Metronidazole (male partner)
Placeob (male partner)

Primary outcomes

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 — 16 weeks post start of receipt of study drug
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.

Countries

United States