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

Phase 1

Completed

• Conditions: Menopause; Healthy
• Interventions: Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA); Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA); Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)

• Registration Number: NCT01477632
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)	-
C	1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)	-
B	0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)	-

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC(0-∞))
Maximal concentration (Cmax)
Time to maximum (tmax)

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) from dosing up to last sample
Terminal half-life (t½)