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

Phase 1

Completed

• Conditions: Menopause; Healthy
• Interventions: Drug: 2 mg estradiol / 1 mg norethisterone acetate (NETA)

• Registration Number: NCT01596010
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Old formulation	2 mg estradiol / 1 mg norethisterone acetate (NETA)	-
New formulation	2 mg estradiol / 1 mg norethisterone acetate (NETA)	-

Primary Outcome Measures

Name	Time	Method
Area under the Curve (0-t)	Up to 72 hours after trial product administration
Cmax, maximum concentration	Up to 72 hours after trial product administration

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	Week 8
Area under the curve from time zero to infinity	Up to 72 hours after trial product administration
Terminal rate constant	Up to 72 hours after trial product administration
Time to maximum (tmax)	Up to 72 hours after trial product administration
Terminal half-life (t½)	Up to 72 hours after trial product administration