Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women
Single Dose, Three-way, Cross-over, Relative Bioavailability Study With 3 Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women: 0.5 mg Estradiol + 0.1 mg Norethisterone Acetate, 0.5 mg Estradiol + 0.25 mg Norethisterone Acetate, and 1.0 mg Estradiol + 0.5 mg Norethisterone Acetate
2 other identifiers
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2005
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 18, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedJanuary 15, 2016
January 1, 2016
3 months
November 18, 2011
January 14, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Area under the curve (AUC(0-∞))
Maximal concentration (Cmax)
Time to maximum (tmax)
Secondary Outcomes (2)
Area Under the Curve (AUC) from dosing up to last sample
Terminal half-life (t½)
Study Arms (3)
A
EXPERIMENTALB
EXPERIMENTALC
ACTIVE COMPARATORInterventions
A single oral dose of 2 tablets under fasting conditions
A single oral dose of 2 tablets under fasting conditions
A single oral dose of 1 tablet under fasting conditions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Neu-Ulm, 89231, Germany
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2011
First Posted
November 22, 2011
Study Start
March 1, 2005
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
January 15, 2016
Record last verified: 2016-01