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

November 18, 2011
March 19, 2012
March 2005
June 2005   (final data collection date for primary outcome measure)
  • 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 ]
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 [ Designated as safety issue: No ]
  • Terminal half-life (t½) [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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
Female
50 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01477632
ALD-1640, 2004-002457-32
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Michael Röhrle Novo Nordisk Pharma GmbH
Novo Nordisk A/S
March 2012

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