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

• Status: Completed
• Trial end date: 2005-05-04
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Norethindrone; Norethindrone Acetate; Polyestradiol phosphate

Criteria

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