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NCT00698035 · OUTCOME

Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range

Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients · Source last updated 2014-06-02

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
12 Weeks

What was measured

Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol \>10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was \>10 pg/dl, subsequent levels \>10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.

Analysis population: Per protocol, to be considered evaluable for the Primary Outcome, patients must complete both baseline evaluation and week 4 safety blood draw. 1 participant in the Testosterone arm was not evaluable.

Groups in this outcome

Estring

Estring 2mg ring inserted vaginally once every 12 weeks

Testosterone Cream

Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment

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

Analysis denominator · Participants

GroupSource count
Estring35
Testosterone Cream33

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Estring0Not reportedNot reportedNot reportedNot reported
Testosterone Cream4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      33
    units
    Participants
description
Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol \>10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was \>10 pg/dl, subsequent levels \>10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.
groups
  1. description
    Estring 2mg ring inserted vaginally once every 12 weeks
    id
    OG000
    title
    Estring
  2. description
    Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
    id
    OG001
    title
    Testosterone Cream
param Type
NUMBER
population Description
Per protocol, to be considered evaluable for the Primary Outcome, patients must complete both baseline evaluation and week 4 safety blood draw. 1 participant in the Testosterone arm was not evaluable.
reporting Status
POSTED
time Frame
12 Weeks
title
Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice