NCT02413008 · OUTCOME

Variation in Serum Levels of Follicle Stimulating Hormone (FSH)

A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting · Source last updated 2019-08-05

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

Measure: MEDIAN
Unit: mIU/ml
Interval / dispersion: Inter-Quartile Range
Time frame: from baseline to 12 weeks of treatment

What was measured

Change from Baseline (mean screening-baseline) to Week 12 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability (screening-baseline variation)

Analysis population: postmenopausal participants

Groups in this outcome

0.005% Estriol Vaginal Gel

Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration

Placebo Vaginal Gel

Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration Placebo

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
0.005% Estriol Vaginal Gel	50
Placebo Vaginal Gel	11

Reported measurements

Source class 1

Values in mIU/ml · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
0.005% Estriol Vaginal Gel	-2.8	Not reported	-13.1	7.4	Not reported
Placebo Vaginal Gel	1.4	Not reported	-5.4	15.7	Not reported

Source statistical analyses

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

group Description
The variations of the levels of FSH after treatment was studied in each women at baseline, week 3 and week12 weeks, the variation of levels between two arms were analysed using a non-parametric test Mann-Whitney-Wilcoxon. The intra individual variation (differences between the pre study determinations screening and baseline) was compared to the variation between baseline and the values obtained at every study visit.
group Ids
OG000
non Inferiority Comment
The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).
non Inferiority Type
OTHER
p Value
0.10
statistical Method
Wilcoxon (Mann-Whitney)
group Description
The variations in the intensities for each one of the symptoms and signs of the vaginal atrophy, after 3 and 12 weeks, in each treatment arm, will be compared using the non-parametric test Mann-Whitney-Wilcoxon.
group Ids
OG001
non Inferiority Comment
The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).
non Inferiority Type
OTHER
p Value
0.413
statistical Method
Wilcoxon (Mann-Whitney)
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.15
statistical Method
Wilcoxon (Mann-Whitney)

Complete source fields

analyses

group Description
The variations of the levels of FSH after treatment was studied in each women at baseline, week 3 and week12 weeks, the variation of levels between two arms were analysed using a non-parametric test Mann-Whitney-Wilcoxon. The intra individual variation (differences between the pre study determinations screening and baseline) was compared to the variation between baseline and the values obtained at every study visit.
group Ids
OG000
non Inferiority Comment
The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).
non Inferiority Type
OTHER
p Value
0.10
statistical Method
Wilcoxon (Mann-Whitney)
group Description
The variations in the intensities for each one of the symptoms and signs of the vaginal atrophy, after 3 and 12 weeks, in each treatment arm, will be compared using the non-parametric test Mann-Whitney-Wilcoxon.
group Ids
OG001
non Inferiority Comment
The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).
non Inferiority Type
OTHER
p Value
0.413
statistical Method
Wilcoxon (Mann-Whitney)
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.15
statistical Method
Wilcoxon (Mann-Whitney)

classes

categories
measurements
group Id
OG000
lower Limit
-13.1
upper Limit
7.4
value
-2.8
group Id
OG001
lower Limit
-5.4
upper Limit
15.7
value
1.4

denoms

counts
group Id
OG000
value
50
group Id
OG001
value
11
units
Participants

description

Change from Baseline (mean screening-baseline) to Week 12 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability (screening-baseline variation)

dispersion Type

Inter-Quartile Range

groups

description
Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration
id
OG000
title
0.005% Estriol Vaginal Gel
description
Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration Placebo
id
OG001
title
Placebo Vaginal Gel

param Type

MEDIAN

population Description

postmenopausal participants

reporting Status

POSTED

time Frame

from baseline to 12 weeks of treatment

title

Variation in Serum Levels of Follicle Stimulating Hormone (FSH)

type

PRIMARY

unit Of Measure

mIU/ml

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

Preserved source evidence · Not medical advice