NCT01076621

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

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®)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 176 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Menopause
• Postmenopausal Bleeding

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2010-02-26
• Last updated: 2014-10-27

Locations

2 sites across 2 countries: Norway, Sweden