Status:
COMPLETED
Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Menopause
Healthy
Eligibility:
FEMALE
50-70 years
Phase:
PHASE1
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/no...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01477632
Start Date
March 1 2005
End Date
June 1 2005
Last Update
January 15 2016
Active Locations (1)
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1
Neu-Ulm, Germany, 89231