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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01477632
First Posted: November 22, 2011
Last Update Posted: January 15, 2016
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
November 18, 2011
November 22, 2011
January 15, 2016
March 2005
June 2005   (Final data collection date for primary outcome measure)
  • Area under the curve (AUC(0-∞))
  • Maximal concentration (Cmax)
  • Time to maximum (tmax)
Same as current
Complete list of historical versions of study NCT01477632 on ClinicalTrials.gov Archive Site
  • Area Under the Curve (AUC) from dosing up to last sample
  • Terminal half-life (t½)
Same as current
Not Provided
Not Provided
 
Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Menopause
  • Healthy
  • Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
    A single oral dose of 2 tablets under fasting conditions
  • Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
    A single oral dose of 2 tablets under fasting conditions
  • Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)
    A single oral dose of 1 tablet under fasting conditions
  • Experimental: A
    Intervention: Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
  • Experimental: B
    Intervention: Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
  • Active Comparator: C
    Intervention: Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2005
June 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
50 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01477632
ALD-1640
2004-002457-32 ( EudraCT Number )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP