Healthy, Menopause
Conditions
Brief summary
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.
Interventions
A single oral dose of 2 tablets under fasting conditions
A single oral dose of 2 tablets under fasting conditions
A single oral dose of 1 tablet under fasting conditions
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC(0-∞)) | — |
| Maximal concentration (Cmax) | — |
| Time to maximum (tmax) | — |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Curve (AUC) from dosing up to last sample | — |
| Terminal half-life (t½) | — |
Countries
Germany
Outcome results
None listed