Clinical trial NCT01596010: Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women
Official title: Single Dose, Double-blind, Two-way Cross-over Bioequivalence Trial With 2 Different Oral Formulations of Estradiol and Norethisterone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Menopause
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-05-10
Enrollment: 44
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the Curve (0-t)
timeFrame: Up to 72 hours after trial product administration
measure: Cmax, maximum concentration
timeFrame: Up to 72 hours after trial product administration
Secondary outcomes:
measure: Time to maximum (tmax)
timeFrame: Up to 72 hours after trial product administration
measure: Area under the curve from time zero to infinity
timeFrame: Up to 72 hours after trial product administration
measure: Terminal half-life (t½)
timeFrame: Up to 72 hours after trial product administration
measure: Terminal rate constant
timeFrame: Up to 72 hours after trial product administration
measure: Incidence of adverse events (AEs)
timeFrame: Week 8
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: