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

Study Overview
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Brief Summary
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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.

Official Title
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A Six Month Double-blind, Randomised, Parallel-group, Placebo-controlled, Multi-centre Trial to Investigate the Efficacy and Safety of Two Ultra-low Dose Combinations With 0.5 mg Estradiol and 0.1 mg or 0.25 mg Norethisterone Acetate (Activelle Low Dose 0.1/Activelle Low Dose 0.25) for Treatment of Menopausal Symptoms

Conditions
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Menopause, Menopausal Vasomotor Symptoms

Intervention / Treatment
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* Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
* Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALD 0.1<br> | Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)<br>* One tablet per day for 24 weeks<br>|
| Experimental: ALD 0.25<br> | Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)<br>* One tablet per day for 24 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Placebo tablets for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean number of moderate to severe hot flushes per week |  | At week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hot flashes