Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Menopause

Treatments: Drug: 2 mg estradiol / 1 mg norethisterone acetate (NETA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01596010

KLI-1915

2007-003350-28 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.

Enrollment: 44 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Postmenopausal defined as at least 12 months spontaneous amenorrhoea, with serum FSH (follicle stimulating hormone) levels at least 40 IU/L and estradiol maximum 25 pg/mL. If the date of spontaneous amenorrhoea can not be identified because of previous hormone replacement therapy, serum FSH at least 40 IU/L and estradiol maximum 25 pg/mL
• Non-smoking
• Body Mass Index (BMI) maximum 35.0 kg/m^2
• Able to understand, read and speak German fluently
• Good state of health evidenced by medical history, physical examination including gynecological examination, and results from laboratory examination
• Willing to abstain from intake of caffeine containing food and beverages within 48 hours before drug administration

Exclusion criteria

• Known or suspected allergy to trial products or related products
• Previous use of oral, transdermal, nasal spray, vaginal preparations and implants within 8 weeks prior to the planned first drug administration
• Known, suspected or history of breast cancer
• Known or suspected estrogen dependent neoplasia e.g. endometrial cancer
• Abnormal genital bleeding of unknown aetiology
• Known insulin dependent as well as non-insulin dependent diabetes mellitus
• Positive test for HIV (human immunodeficiency virus) and/or hepatitis B and C
• Systolic blood pressure (BP) above or equal to 160 mm Hg and/or diastolic BP above or equal to 100 mm Hg, currently treated or untreated

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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44 participants in 2 patient groups

New formulation

Experimental group

Treatment:

Drug: 2 mg estradiol / 1 mg norethisterone acetate (NETA)

Old formulation

Active Comparator group

Treatment:

Drug: 2 mg estradiol / 1 mg norethisterone acetate (NETA)