Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With Estradiol/NETA for 12 Months
Completed
- Conditions
- MenopausePostmenopausal Bleeding
- Interventions
- Registration Number
- NCT01076621
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 176
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
Read More
Exclusion Criteria
Not provided
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA) -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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