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NCT02210689 · OUTCOME

Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score <4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30).

A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women · Source last updated 2020-01-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
22 to 30 days

What was measured

Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows: 1. The original discharge characteristic of bacterial vaginosis has returned to a normal physiological vaginal discharge which varies in appearance and consistency depending on the menstrual cycle, 2. The whiff test is negative for any amine ("fishy") odor, 3. The saline wet mount is negative for clue cells, 4. Vaginal fluid pH is \< 4.7, using pH paper that measures from 3.6 to 6.1. A Bacteriological cure is defined as a Nugent score \< 4. The system used a 0-4 scale (Nugent Scoring System 0-10 for Gram-Stained Vaginal Smears) for evaluation of vaginal flora, based on the weighted sum of the following 3 bacterial morphotypes scores calculated from slide examination under oil immersion field: 1. Lactobacillus: large gram positive rods, 2. Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods, 3. Mobiluncus spp.: thin, curved Gram variable rods

Groups in this outcome

Test Product

One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) clindamycin phosphate vaginal cream 2%

Reference Product

One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of Clindesse® (clindamycin phosphate vaginal cream 2% ) (Ther-Rx™) clindamycin phosphate vaginal cream 2%

Placebo

One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.) placebo: vehicle used as placebo

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Test Product164
Reference Product169
Placebo84

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Test Product36Not reportedNot reportedNot reportedNot reported
Reference Product34Not reportedNot reportedNot reportedNot reported
Placebo9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        34
      3. group Id
        OG002
        value
        9
denoms
  1. counts
    1. group Id
      OG000
      value
      164
    2. group Id
      OG001
      value
      169
    3. group Id
      OG002
      value
      84
    units
    Participants
description
Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows: 1. The original discharge characteristic of bacterial vaginosis has returned to a normal physiological vaginal discharge which varies in appearance and consistency depending on the menstrual cycle, 2. The whiff test is negative for any amine ("fishy") odor, 3. The saline wet mount is negative for clue cells, 4. Vaginal fluid pH is \< 4.7, using pH paper that measures from 3.6 to 6.1. A Bacteriological cure is defined as a Nugent score \< 4. The system used a 0-4 scale (Nugent Scoring System 0-10 for Gram-Stained Vaginal Smears) for evaluation of vaginal flora, based on the weighted sum of the following 3 bacterial morphotypes scores calculated from slide examination under oil immersion field: 1. Lactobacillus: large gram positive rods, 2. Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods, 3. Mobiluncus spp.: thin, curved Gram variable rods
groups
  1. description
    One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) clindamycin phosphate vaginal cream 2%
    id
    OG000
    title
    Test Product
  2. description
    One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of Clindesse® (clindamycin phosphate vaginal cream 2% ) (Ther-Rx™) clindamycin phosphate vaginal cream 2%
    id
    OG001
    title
    Reference Product
  3. description
    One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.) placebo: vehicle used as placebo
    id
    OG002
    title
    Placebo
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
22 to 30 days
title
Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score <4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30).
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice