NCT00984399 · OUTCOME

Change in Serum Estradiol From Baseline to Week 12

Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen · Source last updated 2025-12-09

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: 12 weeks

What was measured

To determine the change in estradiol and follicle stimulating hormone (FSH) from baseline to twelve weeks in postmenopausal women receiving adjuvant aromatase inhibitors during treatment with low dose vaginal 10 µg 17- β estradiol.

Groups in this outcome

Letrozole

This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.

Anastrozole

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

Analysis denominator · Participants

Group	Source count
Letrozole	12
Anastrozole	19

Reported measurements

Baseline estradiol

Values in pg/ml · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Letrozole	5.21	Not reported	0.6	9.8	Not reported
Anastrozole	4.46	Not reported	1.3	8.8	Not reported

Week 12 estradiol

Values in pg/ml · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Letrozole	5.23	Not reported	1	8.7	Not reported
Anastrozole	6.72	Not reported	1.9	18	Not reported

Baseline follicle stimulating hormone (FSH)

Values in pg/ml · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Letrozole	70.92	Not reported	36.4	121.2	Not reported
Anastrozole	68.29	Not reported	19.9	114.5	Not reported

Week 12 follicle stimulating hormone (FSH)

Values in pg/ml · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Letrozole	71.67	Not reported	33.6	115.9	Not reported
Anastrozole	63.28	Not reported	23.4	90.5	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.6
upper Limit
9.8
value
5.21
group Id
OG001
lower Limit
1.3
upper Limit
8.8
value
4.46
title
Baseline estradiol
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
8.7
value
5.23
group Id
OG001
lower Limit
1.9
upper Limit
18
value
6.72
title
Week 12 estradiol
categories
measurements
group Id
OG000
lower Limit
36.4
upper Limit
121.2
value
70.92
group Id
OG001
lower Limit
19.9
upper Limit
114.5
value
68.29
title
Baseline follicle stimulating hormone (FSH)
categories
measurements
group Id
OG000
lower Limit
33.6
upper Limit
115.9
value
71.67
group Id
OG001
lower Limit
23.4
upper Limit
90.5
value
63.28
title
Week 12 follicle stimulating hormone (FSH)

denoms

counts
group Id
OG000
value
12
group Id
OG001
value
19
units
Participants

description

dispersion Type

Full Range

groups

description
This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
id
OG000
title
Letrozole
description
This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.
id
OG001
title
Anastrozole

param Type

MEAN

reporting Status

POSTED

time Frame

12 weeks

title

Change in Serum Estradiol From Baseline to Week 12

type

PRIMARY

unit Of Measure

pg/ml

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

Preserved source evidence · Not medical advice