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NCT01076621 Clinical Trial

Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With Estradiol/NETA for 12 Months

Menopause Clinical Trial

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 (Eviana®)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01076621
Other study ID # ALD-3795
Secondary ID U1111-1112-8626
Status Completed
Phase N/A
First received February 25, 2010
Last updated October 24, 2014
Start date May 2010
Est. completion date June 2013

Study information
Verified date October 2014
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products AgencyNorway: Norwegian Medicines Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 176
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) No
Secondary Change in bleeding profile During the 52 weeks of treatment No
Secondary Change in mean number of hot flushes per week During the 52 weeks of treatment No
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