A Six Month Double-blind, Randomised, Parallel-group, Placebo-controlled, Multi-centre Trial to Investigate the Efficacy and Safety of Two Ultra-low Dose Combinations With 0.5 mg Estradiol and 0.1 mg or 0.25 mg Norethisterone Acetate (Activelle Low Dose 0.1/Activelle Low Dose 0.25) for Treatment of Menopausal Symptoms
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) on frequency and severity of menopausal symptoms, bleeding patterns and safety of different hormonal combinations will be evaluated and compared to placebo over the six month treatment period.
Status: Completed (Phase 3). Started on May 1st, 2004.
Enrollment: 576 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Safety/Efficacy Study
- Intervention Model: Parallel Assignment
- Masking: Double Blind (Subject
- Investigator)
- Primary Purpose: Treatment
Conditions:
Interventions:
- Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
- Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
- Drug: placebo
Eligibility
Inclusion Criteria:
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 Criteria:
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
- Gender
Female
- Mininum Age
45 Years
- Maximum Age
65 Years
- Healthy Volunteers
No
Resources
Source: Novo Nordisk
Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Locations
-
Vienna
Austria
-
Leuven
Belgium
-
Odense
Denmark
-
Helsinki
Finland
-
Nantes
France
-
T��bingen
Germany
-
Trondheim
Norway
-
Gothenburg
Sweden
-
Z��rich
Switzerland
-
Birmingham
United Kingdom
Officials
Irek Otulski, MD (Study Director, Novo Nordisk RE)
Robert Gut, MD, PhD (Study Director, Novo Nordisk RE)
Sponsors
Novo Nordisk (Lead Sponsor)
References
None.
Links
- Date Verified
- November 1st, 2011
- First Received
- November 18th, 2011
- Last Changed
- November 18th, 2011
Information obtained from ClinicalTrials.gov on November 21, 2011. Link to the current ClinicalTrials.gov record.
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