Status:
COMPLETED
Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Menopause
Menopausal Vasomotor Symptoms
Eligibility:
FEMALE
45-65 years
Phase:
PHASE3
Brief Summary
This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone replacement therapy) ...
Eligibility Criteria
Inclusion
- Postmenopausal status
- Subject should have had a minimum of 7 moderate to severe hot flushes per day, or a minimum of 50 moderate to severe hot flushes per week, during the last 2 weeks of the run-in (screening) period.
- Subject with an intact uterus
Exclusion
- In accordance with existing labelling for estrogen/progestogen combinations
- Body Mass Index (BMI) \> 35.0 kg/m2
- Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
- Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to influence estrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepin
Key Trial Info
Start Date :
May 28 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2005
Estimated Enrollment :
576 Patients enrolled
Trial Details
Trial ID
NCT00184795
Start Date
May 28 2004
End Date
May 4 2005
Last Update
February 23 2017
Active Locations (91)
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1
Novo Nordisk Investigational Site
Vienna, Austria, A 1060
2
Novo Nordisk Investigational Site
Vienna, Austria, A 1090
3
Novo Nordisk Investigational Site
Brussels, Belgium, 1000
4
Novo Nordisk Investigational Site
Brussels, Belgium, 1180