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

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ClinicalTrials.gov Identifier: NCT01477632
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : January 15, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2005
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Estradiol
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Area under the curve (AUC(0-∞))
  2. Maximal concentration (Cmax)
  3. Time to maximum (tmax)

Secondary Outcome Measures :
  1. Area Under the Curve (AUC) from dosing up to last sample
  2. Terminal half-life (t½)


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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:

  • 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

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): NCT01477632


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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01477632     History of Changes
Other Study ID Numbers: ALD-1640
2004-002457-32 ( EudraCT Number )
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016

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