Healthy, Menopause
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.
Interventions
DRUG2 mg estradiol / 1 mg norethisterone acetate (NETA)
A single dose of one tablet under fasting conditions separated by a wash-out period of 2 weeks (+0-2 days) between dosing visits. Administered orally.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Postmenopausal defined as at least 12 months spontaneous amenorrhoea, with serum FSH (follicle stimulating hormone) levels at least 40 IU/L and estradiol maximum 25 pg/mL. If the date of spontaneous amenorrhoea can not be identified because of previous hormone replacement therapy, serum FSH at least 40 IU/L and estradiol maximum 25 pg/mL * Non-smoking * Body Mass Index (BMI) maximum 35.0 kg/m\^2 * Able to understand, read and speak German fluently * Good state of health evidenced by medical history, physical examination including gynecological examination, and results from laboratory examination * Willing to abstain from intake of caffeine containing food and beverages within 48 hours before drug administration
Exclusion criteria
* Known or suspected allergy to trial products or related products * Previous use of oral, transdermal, nasal spray, vaginal preparations and implants within 8 weeks prior to the planned first drug administration * Known, suspected or history of breast cancer * Known or suspected estrogen dependent neoplasia e.g. endometrial cancer * Abnormal genital bleeding of unknown aetiology * Known insulin dependent as well as non-insulin dependent diabetes mellitus * Positive test for HIV (human immunodeficiency virus) and/or hepatitis B and C * Systolic blood pressure (BP) above or equal to 160 mm Hg and/or diastolic BP above or equal to 100 mm Hg, currently treated or untreated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the Curve (0-t) | Up to 72 hours after trial product administration |
| Cmax, maximum concentration | Up to 72 hours after trial product administration |
Secondary
| Measure | Time frame |
|---|---|
| Terminal half-life (t½) | Up to 72 hours after trial product administration |
| Time to maximum (tmax) | Up to 72 hours after trial product administration |
| Incidence of adverse events (AEs) | Week 8 |
| Terminal rate constant | Up to 72 hours after trial product administration |
| Area under the curve from time zero to infinity | Up to 72 hours after trial product administration |
Countries
Germany
Outcome results
None listed