DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menopause; Postmenopausal Bleeding

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

Phase: N/A

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

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.

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 (Eviana®)

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 profile

Change 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 previously 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

Rud 1309, Norway

Göteborg 416 85, Sweden

Additional Information

Clinical Trials at Novo Nordisk

Starting date: May 2010
Last updated: October 24, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017