Healthy, Menopause
Conditions
Brief summary
This study is conducted in Europe. The aim of this study is to investigate the bleeding profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)).
Interventions
After a screening period of 12 weeks (three lunar months) in which the subjects still are on Trisekvens® followed by a treatment period of 24 weeks (six lunar months) in which the subjects are treated with Activelle®.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy women * At least 3 months on Trisekvens® before screening period * Ability to understand and comply with the protocol requirements
Exclusion criteria
* Less than 12 months or more than 36 months postmenopausal judged by the Investigator * Known, suspected, or past history of hormone dependent tumor/cancers * Deep venous thrombosis, active thrombophlebitis, thromboembolic disorders, cerebrovascular accidents or past history of these conditions * Ischemic heart disease or myocardial infarction within 6 months prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postmenopausal women's acceptance of bleeding | After 24 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding profile in postmenopausal women | After 24 weeks of treatment |
| Acceptance of hot flushes and breast tenderness | After 24 weeks of treatment |
Countries
Norway, Sweden
Outcome results
None listed