NCT01076621CompletedNot Applicable
A 12 Month Non-interventional (Observational), International, Multi-centre, Prospective Study to Evaluate the Bleeding Pattern of Ultra-low Dose Continuous Combined Hormone Replacement Therapy Containing 0.5 mg Estradiol and 0.1 mg Norethisterone Acetate (Eviana®)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 176
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts 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
Exclusion Criteria
- Not provided
Arms & Interventions
A
Intervention: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA) (Drug)
Outcomes
Primary Outcomes
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
Time Frame: At every lunar month (28 days)
Secondary Outcomes
- 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)
Investigators
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