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

Phase 3

Completed

• Conditions: Menopause; Menopausal Vasomotor Symptoms
• Interventions: Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA); Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA); Drug: placebo

• Registration Number: NCT00184795
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05-28
• Primary Completion: 2005-05-04
• Study Completion: 2005-05-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-16
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 576

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALD 0.1	0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)	-
ALD 0.25	0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Change in mean number of moderate to severe hot flushes per week	At week 8

Secondary Outcome Measures

Name	Time	Method
Urogenital symptoms	Week 0; week 24
Vaginal cytology and pH	Week 0; week 24
Bleeding profile	Week 0; week 24
Adverse Events	Week 0; week 24
Menopausal symptoms and quality of life (Greene Climacteric Scale)	Week 0; week 24
Hot flush weekly weighted score	Week 0; week 24

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 WAtford, United Kingdom