NCT01370551 · OUTCOME

Calculation of Pharmacokinetic Parameters Estriol: Area Under the Curve (AUC)

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.

What was measured

Area under the curve from administration to the last measured concentration (AUC0-24)

Analysis population: PP

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

AUC (0-24h) (Day 0)

Values in hours * pg/ml · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Gynoflor	212	93.2	Not reported	Not reported	Not reported

AUC (0-24h) (Day 28)

Values in hours * pg/ml · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Gynoflor	130.7	147.2	Not reported	Not reported	Not reported

Complete source fields

classes

denoms

description

Area under the curve from administration to the last measured concentration (AUC0-24)

dispersion Type

Standard Deviation

groups

param Type

MEAN

population Description

reporting Status

POSTED

time Frame

Days 0 and 28

title

Calculation of Pharmacokinetic Parameters Estriol: Area Under the Curve (AUC)

type

PRIMARY

unit Of Measure

hours * pg/ml

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

Preserved source evidence · Not medical advice