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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01596010
First received: May 9, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Menopause
Healthy
 Drug: 2 mg estradiol / 1 mg norethisterone acetate (NETA)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Single Dose, Double-blind, Two-way Cross-over Bioequivalence Trial With 2 Different Oral Formulations of Estradiol and Norethisterone

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the Curve (0-t) [ Time Frame: Up to 72 hours after trial product administration ] [ Designated as safety issue: No ]
  • Cmax, maximum concentration [ Time Frame: Up to 72 hours after trial product administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to maximum (tmax) [ Time Frame: Up to 72 hours after trial product administration ] [ Designated as safety issue: No ]
  • Area under the curve from time zero to infinity [ Time Frame: Up to 72 hours after trial product administration ] [ Designated as safety issue: No ]
  • Terminal half-life (t½) [ Time Frame: Up to 72 hours after trial product administration ] [ Designated as safety issue: No ]
  • Terminal rate constant [ Time Frame: Up to 72 hours after trial product administration ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: October 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New formulation 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.
Active Comparator: Old formulation 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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596010

Locations
Germany
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Birte K. Skrumsager Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01596010     History of Changes
Other Study ID Numbers: KLI-1915, 2007-003350-28
Study First Received: May 9, 2012
Last Updated: May 9, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Norethindrone
Norethindrone acetate
Estrogens
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 23, 2013