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

Novo Nordisk

Status: Completed

Conditions: Menopause; Postmenopausal Bleeding

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01076621

ALD-3795

U1111-1112-8626 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 176 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

176 participants in 1 patient group

A

Treatment:

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