NCT01370551 · OUTCOME

Baseline / Trough Serum Concentrations of Follicule Stimulating Hormone (FSH)

Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients · Source last updated 2024-10-15

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

Measure: MEAN
Unit: mIU/ml
Interval / dispersion: Standard Deviation
Time frame: Days 0, 14, 28, 56 and 84

Analysis population: PP

Groups in this outcome

Gynoflor

This study consists only of this arm. Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;

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
Gynoflor	16

Reported measurements

FSH (Day 0)

Values in mIU/ml · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Gynoflor	107.88	48.62	Not reported	Not reported	Not reported

FSH (Day 14)

Values in mIU/ml · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Gynoflor	103.71	39.76	Not reported	Not reported	Not reported

FSH (Day 28)

Values in mIU/ml · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Gynoflor	98.94	34.95	Not reported	Not reported	Not reported

FSH (Day 56)

Values in mIU/ml · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Gynoflor	103.55	37.53	Not reported	Not reported	Not reported

FSH (Day 84)

Values in mIU/ml · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Gynoflor	105.93	43.69	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
48.62
value
107.88
title
FSH (Day 0)
categories
measurements
group Id
OG000
spread
39.76
value
103.71
title
FSH (Day 14)
categories
measurements
group Id
OG000
spread
34.95
value
98.94
title
FSH (Day 28)
categories
measurements
group Id
OG000
spread
37.53
value
103.55
title
FSH (Day 56)
categories
measurements
group Id
OG000
spread
43.69
value
105.93
title
FSH (Day 84)

denoms

counts
group Id
OG000
value
16
units
Participants

dispersion Type

Standard Deviation

groups

description
This study consists only of this arm. Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;
id
OG000
title
Gynoflor

param Type

MEAN

population Description

reporting Status

POSTED

time Frame

Days 0, 14, 28, 56 and 84

title

Baseline / Trough Serum Concentrations of Follicule Stimulating Hormone (FSH)

type

SECONDARY

unit Of Measure

mIU/ml

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

Preserved source evidence · Not medical advice