Participant flow

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.

groups

1. description

   One single-dose, pre-filled, disposable applicator of investigational product was to be administered intravaginally at home.

   id

   FG000

   title

   Generic Clindamycin Phosphate Vaginal Cream 2%

2. description

   One single-dose, pre-filled, disposable applicator of Investigational product to be administered intravaginally at home.

   id

   FG001

   title

   Clindesse (Clindamycin Phosphate Vaginal Cream 2%)

3. description

   One single-dose, pre-filled, disposable applicator of Investigational product was to be inserted intravaginally at home.

   id

   FG002

   title

   Vehicle Cream

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         2

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Protocol Violation

   4. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         5

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Pregnancy

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         5

      type

      Lack of Efficacy

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         1

      type

      Prohibited medication

   8. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      type

      Negative Nugent score at baseline

   9. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         21

      3. group Id

         FG002

         num Subjects

         8

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         242

      2. group Id

         FG001

         num Subjects

         240

      3. group Id

         FG002

         num Subjects

         122

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         233

      2. group Id

         FG001

         num Subjects

         236

      3. group Id

         FG002

         num Subjects

         122

      comment

      Randomized participants who received the investigational product.

      type

      Safety Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         199

      2. group Id

         FG001

         num Subjects

         207

      3. group Id

         FG002

         num Subjects

         107

      comment

      Randomized participants that applied the study dose, and returned for post-baseline evaluation visit

      type

      mITT Population

   4. achievements

      1. group Id

         FG000

         num Subjects

         164

      2. group Id

         FG001

         num Subjects

         169

      3. group Id

         FG002

         num Subjects

         84

      comment

      Randomized subjects that were compliant with study treatment, and completed the study.

      type

      PP Population

   5. achievements

      1. group Id

         FG000

         num Subjects

         190

      2. group Id

         FG001

         num Subjects

         193

      3. group Id

         FG002

         num Subjects

         99

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         52

      2. group Id

         FG001

         num Subjects

         47

      3. group Id

         FG002

         num Subjects

         23

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The populations for this study included the Safety Population, the Per-Protocol (PP) Population, and the Modified Intent-to-treat (mITT) Population.

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Preserved source evidence · Not medical advice