Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women

Healthy Clinical Trial

Official title:

Single Dose, Double-blind, Two-way Cross-over Bioequivalence Trial With 2 Different Oral Formulations of Estradiol and Norethisterone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596010
• Other study ID #: KLI-1915
• Secondary ID: 2007-003350-28
• Status: Completed
• Phase: Phase 1
• First received: May 9, 2012
• Last updated: March 17, 2015
• Start date: October 2007
• Est. completion date: November 2007

Study information

• Verified date: March 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy
• Menopause

Intervention

Drug:
• 2 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Curve (0-t)		Up to 72 hours after trial product administration	No
Primary	Cmax, maximum concentration		Up to 72 hours after trial product administration	No
Secondary	Time to maximum (tmax)		Up to 72 hours after trial product administration	No
Secondary	Area under the curve from time zero to infinity		Up to 72 hours after trial product administration	No
Secondary	Terminal half-life (t½)		Up to 72 hours after trial product administration	No
Secondary	Terminal rate constant		Up to 72 hours after trial product administration	No
Secondary	Incidence of adverse events (AEs)		Week 8	No

External Links

•   Clinical Trials at Novo Nordisk