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

Novo Nordisk A/S176 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

176

Conditions

Menopause Postmenopausal Bleeding

Interventions

0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)DRUG

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.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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 (2)

Unnamed facility

Rud, Norway

Unnamed facility

Gothenburg, Sweden

Outcomes

Primary Outcomes

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

Time frame: At every lunar month (28 days)

Secondary Outcomes

Change in bleeding profile

Time frame: During the 52 weeks of treatment

Change in mean number of hot flushes per week

Time frame: During the 52 weeks of treatment

Data from ClinicalTrials.gov

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