Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women

Novo Nordisk A/S24 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a marketed estradiol/norethisterone acetate (NETA) preparation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Menopause Healthy

Interventions

0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)DRUG

A single oral dose of 2 tablets under fasting conditions

0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)DRUG

A single oral dose of 2 tablets under fasting conditions

1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)DRUG

A single oral dose of 1 tablet under fasting conditions

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy * Postmenopausal * Caucasian race * Smoking (up to 5 cig./per day) is allowed * Good state of health: evidenced by medical history, physical examination including gynecological examination, results of laboratory examination Exclusion Criteria: * Known or suspected allergy to trial products or related products * Previous participation in this trial * Previous estrogen and/or progestin hormone replacement therapy * Known, suspected or history of breast cancer * Systolic blood pressure (BP) at least 160 mm Hg and/or diastolic BP at least 100 mm Hg, currently treated or untreated * Body Mass Index (BMI) above 35.0 kg/m\^2

Locations (1)

Unnamed facility

Neu-Ulm, Germany

Outcomes

Primary Outcomes

Area under the curve (AUC(0-∞))

Maximal concentration (Cmax)

Time to maximum (tmax)

Secondary Outcomes

Area Under the Curve (AUC) from dosing up to last sample

Terminal half-life (t½)

Data from ClinicalTrials.gov

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