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NCT01923298 · OUTCOME

Changes in Serum Estradiol

Estradiol Levels in Patients Treated With Estring · Source last updated 2022-02-10

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

Measure
MEDIAN
Unit
pg/mL
Interval / dispersion
Full Range
Time frame
Baseline, 16 weeks

What was measured

To measure changes in serum estradiol level compared to their baseline in patients with breast cancer when treated with vaginal estrogen preparation, Estring

Analysis population: Eligible patients were 18 years or older, diagnosed with HR-positive breast cancer defined as \> 1% of tumor cells expressing estrogen or progesterone receptors, attained menopause as defined by the World Health Organization, and on adjuvant hormonal therapy with an aromatase inhibitor- anastrozole, letrozole, or exemestane. Patients with metastatic disease were excluded.

Groups in this outcome

Estring Group

ESTRING® (estradiol vaginal ring) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol. Estradiol, silicone polymers and barium sulfate are combined to form the ring. When placed in the vagina, ESTRING releases estradiol, approximately 7.5 mcg per 24 hours, in a consistent stable manner over 90 days.

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

Analysis denominator · Participants

GroupSource count
Estring Group14

Reported measurements

Source class 1
Values in pg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Estring Group3.9Not reported1.18.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.1
        upper Limit
        8.9
        value
        3.9
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
To measure changes in serum estradiol level compared to their baseline in patients with breast cancer when treated with vaginal estrogen preparation, Estring
dispersion Type
Full Range
groups
  1. description
    ESTRING® (estradiol vaginal ring) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol. Estradiol, silicone polymers and barium sulfate are combined to form the ring. When placed in the vagina, ESTRING releases estradiol, approximately 7.5 mcg per 24 hours, in a consistent stable manner over 90 days.
    id
    OG000
    title
    Estring Group
param Type
MEDIAN
population Description
Eligible patients were 18 years or older, diagnosed with HR-positive breast cancer defined as \> 1% of tumor cells expressing estrogen or progesterone receptors, attained menopause as defined by the World Health Organization, and on adjuvant hormonal therapy with an aromatase inhibitor- anastrozole, letrozole, or exemestane. Patients with metastatic disease were excluded.
reporting Status
POSTED
time Frame
Baseline, 16 weeks
title
Changes in Serum Estradiol
type
PRIMARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice