MedTrace Logo

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

NCT01477632 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-01-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)

A single oral dose of 2 tablets under fasting conditions

DRUG

0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)

A single oral dose of 2 tablets under fasting conditions

DRUG

1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)

A single oral dose of 1 tablet under fasting conditions

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2005-06-30
Completion
2005-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01477632 on ClinicalTrials.gov