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

Overview

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.

Full Title of Study: “Single Dose, Double-blind, Two-way Cross-over Bioequivalence Trial With 2 Different Oral Formulations of Estradiol and Norethisterone”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2007

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: New formulation
  • Active Comparator: Old formulation

Clinical Trial Outcome Measures

Primary Measures

  • Area under the Curve (0-t)
    • Time Frame: Up to 72 hours after trial product administration
  • Cmax, maximum concentration
    • Time Frame: Up to 72 hours after trial product administration

Secondary Measures

  • Time to maximum (tmax)
    • Time Frame: Up to 72 hours after trial product administration
  • Area under the curve from time zero to infinity
    • Time Frame: Up to 72 hours after trial product administration
  • Terminal half-life (t½)
    • Time Frame: Up to 72 hours after trial product administration
  • Terminal rate constant
    • Time Frame: Up to 72 hours after trial product administration
  • Incidence of adverse events (AEs)
    • Time Frame: Week 8

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 50 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Novo Nordisk A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S

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