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NCT01370551 · OUTCOME

Serum Concentrations of Estriol (E3)

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
pg/ml
Interval / dispersion
Full Range
Time frame
-0.5, 0.5, 1, 2, 3, 4, 6, 8, 24 hours on days 0 and 28

What was measured

Estrogens were analyzed using a highly sensitive gas chromatography-mass spectrometry (GC/MS) method. The lower limits of quantitation (LLOQ) were 10.00 pg/ml for E3, 1.The coefficient of variation (CV, intra-assay variation) was 2.0 % for E3 (calibration range (CR) 10.00-500.00 pg/). The lower limits of quantitation (LLOQ) were 1.00 pg/ml for E2, and 2.00 pg/ml for E1.The coefficient of variation (CV, intra-assay variation) was 4.2 % for E2 (CR 1.00-150.00 pg/ml), and 3.4 % for E1 (CR 2.00-300.00 pg/ml).

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

-0.5 h (Day 0)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor0Not reported00Not reported
-0.5 h (Day 28)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor0.91Not reported014.5Not reported
0.5 h (Day 0)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor3.83Not reported014.10Not reported
0.5 h (Day 28)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor1.58Not reported012.90Not reported
1 h (Day 0)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor11.04Not reported018.8Not reported
1 h (Day 28)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor1.55Not reported014.40Not reported
2 h (Day 0)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor72.73Not reported0168Not reported
2 h (Day 28)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor1.96Not reported0.0016.60Not reported
3 h (Day 0)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor84.35Not reported0.00160.00Not reported
3 h (Day 28)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor2.48Not reported0.0029.20Not reported
4 h (Day 0)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor28.29Not reported0.0067.50Not reported
4 h (Day 28)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor3.12Not reported0.0037.70Not reported
6 h (Day 0)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor0.00Not reported0.000.00Not reported
6 h (Day 28)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor7.33Not reported0.0039.50Not reported
8 h (Day 0)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor0.00Not reported0.000.00Not reported
8 h (Day 28)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor10.23Not reported0.0043.70Not reported
24 h (Day 0)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor0.00Not reported0.000.00Not reported
24 h (Day 28)
Values in pg/ml · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Gynoflor0.00Not reported0.000.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
    title
    -0.5 h (Day 0)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        14.5
        value
        0.91
    title
    -0.5 h (Day 28)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        14.10
        value
        3.83
    title
    0.5 h (Day 0)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        12.90
        value
        1.58
    title
    0.5 h (Day 28)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        18.8
        value
        11.04
    title
    1 h (Day 0)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        14.40
        value
        1.55
    title
    1 h (Day 28)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        168
        value
        72.73
    title
    2 h (Day 0)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        16.60
        value
        1.96
    title
    2 h (Day 28)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        160.00
        value
        84.35
    title
    3 h (Day 0)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        29.20
        value
        2.48
    title
    3 h (Day 28)
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        67.50
        value
        28.29
    title
    4 h (Day 0)
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        37.70
        value
        3.12
    title
    4 h (Day 28)
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Estrogens were analyzed using a highly sensitive gas chromatography-mass spectrometry (GC/MS) method. The lower limits of quantitation (LLOQ) were 10.00 pg/ml for E3, 1.The coefficient of variation (CV, intra-assay variation) was 2.0 % for E3 (calibration range (CR) 10.00-500.00 pg/). The lower limits of quantitation (LLOQ) were 1.00 pg/ml for E2, and 2.00 pg/ml for E1.The coefficient of variation (CV, intra-assay variation) was 4.2 % for E2 (CR 1.00-150.00 pg/ml), and 3.4 % for E1 (CR 2.00-300.00 pg/ml).
dispersion Type
Full Range
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
reporting Status
POSTED
time Frame
-0.5, 0.5, 1, 2, 3, 4, 6, 8, 24 hours on days 0 and 28
title
Serum Concentrations of Estriol (E3)
type
PRIMARY
unit Of Measure
pg/ml

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

Preserved source evidence · Not medical advice