Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01477632
First received: November 18, 2011
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

This trial is conducted in Europe. The aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a marketed estradiol/norethisterone acetate (NETA) preparation.


Condition Intervention Phase
Menopause
Healthy
Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Dose, Three-way, Cross-over, Relative Bioavailability Study With 3 Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women: 0.5 mg Estradiol + 0.1 mg Norethisterone Acetate, 0.5 mg Estradiol + 0.25 mg Norethisterone Acetate, and 1.0 mg Estradiol + 0.5 mg Norethisterone Acetate

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the curve (AUC(0-∞)) [ Designated as safety issue: No ]
  • Maximal concentration (Cmax) [ Designated as safety issue: No ]
  • Time to maximum (tmax) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area Under the Curve (AUC) from dosing up to last sample [ Designated as safety issue: No ]
  • Terminal half-life (t½) [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2005
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
A single oral dose of 2 tablets under fasting conditions
Experimental: B Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
A single oral dose of 2 tablets under fasting conditions
Active Comparator: C Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)
A single oral dose of 1 tablet under fasting conditions

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Postmenopausal
  • Caucasian race
  • Smoking (up to 5 cig./per day) is allowed
  • Good state of health: evidenced by medical history, physical examination including gynecological examination, results of laboratory examination

Exclusion Criteria:

  • Known or suspected allergy to trial products or related products
  • Previous participation in this trial
  • Previous estrogen and/or progestin hormone replacement therapy
  • Known, suspected or history of breast cancer
  • Systolic blood pressure (BP) at least 160 mm Hg and/or diastolic BP at least 100 mm Hg, currently treated or untreated
  • Body Mass Index (BMI) above 35.0 kg/m^2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477632

Locations
Germany
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Michael Röhrle Novo Nordisk Pharma GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01477632     History of Changes
Other Study ID Numbers: ALD-1640, 2004-002457-32
Study First Received: November 18, 2011
Last Updated: March 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
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 September 18, 2014