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NCT00698035 · OUTCOME

Matched E2 by Commercial and Research (RIA) Analyses

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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
Standard Deviation
Time frame
baseline, 4 weeks

What was measured

Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women

Analysis population: Patients from both study arms arms with matched pairs of baseline and week 4 E2 performed by both commercial and research labs

Groups in this outcome

E2 by LC/MS

A commercially available ultrasensitive E2 level was measured at baseline and 4 weeks (Quest Diagnostics, liquid chromatography tandem mass spectrometry (LC/MS, PM range \<10 pg/ml)

E2 by RIA

Additional measurement of baseline and week 4 E2 by RIA

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

Analysis denominator · Participants

GroupSource count
E2 by LC/MS63
E2 by RIA63

Reported measurements

Baseline E2
Values in pg/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
E2 by LC/MS17.728.5Not reportedNot reportedNot reported
E2 by RIA17.944.1Not reportedNot reportedNot reported
4-week E2
Values in pg/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
E2 by LC/MS7.815.0Not reportedNot reportedNot reported
E2 by RIA2.913.4Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    Comparison of baseline estradiol between LC/MS and RIA
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    >0.05
    p Value Comment
    Significant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  2. group Description
    Comparison of week 4 estradiol between LC/MS and RIA
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    >0.05
    p Value Comment
    singificant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Description
    Comparison of baseline estradiol between LC/MS and RIA
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    >0.05
    p Value Comment
    Significant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  2. group Description
    Comparison of week 4 estradiol between LC/MS and RIA
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    >0.05
    p Value Comment
    singificant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.5
        value
        17.7
      2. group Id
        OG001
        spread
        44.1
        value
        17.9
    title
    Baseline E2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.0
        value
        7.8
      2. group Id
        OG001
        spread
        13.4
        value
        2.9
    title
    4-week E2
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      63
    units
    Participants
description
Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women
dispersion Type
Standard Deviation
groups
  1. description
    A commercially available ultrasensitive E2 level was measured at baseline and 4 weeks (Quest Diagnostics, liquid chromatography tandem mass spectrometry (LC/MS, PM range \<10 pg/ml)
    id
    OG000
    title
    E2 by LC/MS
  2. description
    Additional measurement of baseline and week 4 E2 by RIA
    id
    OG001
    title
    E2 by RIA
param Type
MEAN
population Description
Patients from both study arms arms with matched pairs of baseline and week 4 E2 performed by both commercial and research labs
reporting Status
POSTED
time Frame
baseline, 4 weeks
title
Matched E2 by Commercial and Research (RIA) Analyses
type
SECONDARY
unit Of Measure
pg/ml

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Preserved source evidence · Not medical advice