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NCT01370551 · OUTCOME

Baseline / Trough Serum Concentrations of Luteinizing Hormone (LH)

Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients · Source last updated 2024-10-15

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

Measure
MEAN
Unit
mIU/ml
Interval / dispersion
Standard Deviation
Time frame
Days 0, 14, 28, 56 and 84

Analysis population: PP

Groups in this outcome

Gynoflor

Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; once daily for 28 days then 3 times per week for 8 weeks

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

Analysis denominator · Participants

GroupSource count
Gynoflor16

Reported measurements

LH (Day 0)
Values in mIU/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Gynoflor36.4611.05Not reportedNot reportedNot reported
LH (Day 14)
Values in mIU/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Gynoflor34.5212.18Not reportedNot reportedNot reported
LH (Day 28)
Values in mIU/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Gynoflor34.0212.68Not reportedNot reportedNot reported
LH (Day 56)
Values in mIU/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Gynoflor34.249.87Not reportedNot reportedNot reported
LH (Day 84)
Values in mIU/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Gynoflor35.1310.34Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.05
        value
        36.46
    title
    LH (Day 0)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.18
        value
        34.52
    title
    LH (Day 14)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.68
        value
        34.02
    title
    LH (Day 28)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.87
        value
        34.2
    title
    LH (Day 56)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.34
        value
        35.13
    title
    LH (Day 84)
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; once daily for 28 days then 3 times per week for 8 weeks
    id
    OG000
    title
    Gynoflor
param Type
MEAN
population Description
PP
reporting Status
POSTED
time Frame
Days 0, 14, 28, 56 and 84
title
Baseline / Trough Serum Concentrations of Luteinizing Hormone (LH)
type
SECONDARY
unit Of Measure
mIU/ml

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

Preserved source evidence · Not medical advice