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

Novo Nordisk A/S576 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

576

Conditions

Menopause Menopausal Vasomotor Symptoms

Interventions

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

One tablet per day for 24 weeks

0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)DRUG

One tablet per day for 24 weeks

placeboDRUG

Placebo tablets for 24 weeks

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (91)

Outcomes

Primary Outcomes

Change in mean number of moderate to severe hot flushes per week

Time frame: At week 8

Secondary Outcomes

Urogenital symptoms

Time frame: Week 0; week 24

Vaginal cytology and pH

Time frame: Week 0; week 24

Bleeding profile

Time frame: Week 0; week 24

Adverse Events

Time frame: Week 0; week 24

Menopausal symptoms and quality of life (Greene Climacteric Scale)

Time frame: Week 0; week 24

Hot flush weekly weighted score

Time frame: Week 0; week 24

Data from ClinicalTrials.gov

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