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OpenTrials
Completed

NCT Number: NCT01477632

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

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.

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Key information

Conditions

Menopause Healthy

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Neu-Ulm, 89231, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)

Drug

A single oral dose of 2 tablets under fasting conditions

0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)

Drug

A single oral dose of 2 tablets under fasting conditions

1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)

Drug

A single oral dose of 1 tablet under fasting conditions

Primary outcomes

  1. Area under the curve (AUC(0-∞))

  2. Maximal concentration (Cmax)

  3. Time to maximum (tmax)

Secondary outcomes

  1. Area Under the Curve (AUC) from dosing up to last sample

  2. Terminal half-life (t½)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Nov 22, 2011
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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