Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With 0.5 mg Estradiol and 0.1 mg Norethisterone Acetate for 12 Months
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hormone Replacement Therapy, Post-Menopausal
Intervention: 0.5 mg estradiol and 0.1mg norethisterone acetate (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Marta Kokot-Kierepa, Study Director, Affiliation: Novo Nordisk Scandinavia AS
Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
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 for 12 months.
Clinical Details
Official title: 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 (EvianaŽ)
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: 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
Secondary outcome: Change in bleeding profileChange in mean number of hot flushes per week
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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 preciously combined HRT discontinued at least 3 months prior to start
of 0. 5 mg estradiol and 0. 1 mg norethisterone acetate treatment
Locations and Contacts
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
Rud 1309, Norway; Recruiting
Lund 221 85, Sweden; Recruiting
Additional Information
Clinical Trials at Novo Nordisk
Starting date: May 2010
Last updated: May 18, 2010
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