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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Menopause

Treatments: Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA); Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA); Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01477632

ALD-1640

2004-002457-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

A

Experimental group

Treatment:

Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)

B

Experimental group

Treatment:

Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)

C

Active Comparator group

Treatment:

Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)