Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations (CHOICE)

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Menopause

Menopausal Vasomotor Symptoms

Treatments

Drug: placebo

Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00184795

2004-000103-17 (EudraCT Number)

ALD-1537

Details and patient eligibility

About

This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone replacement therapy) on frequency and severity of menopausal symptoms, bleeding patterns and safety of different hormonal combinations will be evaluated and compared to placebo over the six month treatment period.

Enrollment

576 patients

Sex

Female

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Postmenopausal status
Subject should have had a minimum of 7 moderate to severe hot flushes per day, or a minimum of 50 moderate to severe hot flushes per week, during the last 2 weeks of the run-in (screening) period.
Subject with an intact uterus

Exclusion criteria

In accordance with existing labelling for estrogen/progestogen combinations
Body Mass Index (BMI) > 35.0 kg/m2
Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to influence estrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepin