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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01596010
First Posted: May 10, 2012
Last Update Posted: March 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome 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 Outcome 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596010


Locations
Germany
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01596010     History of Changes
Other Study ID Numbers: KLI-1915
2007-003350-28 ( EudraCT Number )
First Submitted: May 9, 2012
First Posted: May 10, 2012
Last Update Posted: March 18, 2015
Last Verified: March 2015

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