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

March 17, 2015 updated by: Novo Nordisk A/S

Single Dose, Double-blind, Two-way Cross-over Bioequivalence Trial With 2 Different Oral Formulations of Estradiol and Norethisterone

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New formulation
Drug: 2 mg estradiol / 1 mg norethisterone acetate (NETA)
A single dose of one tablet under fasting conditions separated by a wash-out period of 2 weeks (+0-2 days) between dosing visits. Administered orally.
Active Comparator: Old formulation
Drug: 2 mg estradiol / 1 mg norethisterone acetate (NETA)
A single dose of one tablet under fasting conditions separated by a wash-out period of 2 weeks (+0-2 days) between dosing visits. Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the Curve (0-t)
Time Frame: Up to 72 hours after trial product administration
Up to 72 hours after trial product administration
Cmax, maximum concentration
Time Frame: Up to 72 hours after trial product administration
Up to 72 hours after trial product administration

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 10, 2012

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLI-1915
  • 2007-003350-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on 2 mg estradiol / 1 mg norethisterone acetate (NETA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe