Menopause, Postmenopausal Bleeding
Conditions
Brief summary
This study is conducted in Europe. The primary aim of this observational study is to investigate the occurrence of bleeding in women taking 0.5 mg estradiol and 0.1 mg norethisterone acetate (NETA) for 12 months.
Interventions
Data collection of the use of 0.5 mg estradiol and 0.1 mg norethisterone acetate (NETA) in women in connection to a daily clinical practice.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Informed consent, permitting the data to be processed within the scope of the study, is obtained from the patient before any study-related activities * Postmenopausal amenorrhoeic women * Treatment with previously combined HRT discontinued at least 3 months prior to start of 0.5 mg estradiol and 0.1 mg norethisterone acetate treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleeding profile during the 52 weeks of treatment with 0.5 mg estradiol and 0.1 mg norethisterone acetate evaluated by bleeding, and bleeding or spotting rates | At every lunar month (28 days) |
Secondary
| Measure | Time frame |
|---|---|
| Change in bleeding profile | During the 52 weeks of treatment |
| Change in mean number of hot flushes per week | During the 52 weeks of treatment |
Countries
Norway, Sweden
Outcome results
None listed