Menopause Clinical Trial
— CHOICEOfficial title:
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
| Verified date | February 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 576 |
| Est. completion date | May 4, 2005 |
| Est. primary completion date | May 4, 2005 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 45 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Belgium | Novo Nordisk Investigational Site | Brussels | |
| Belgium | Novo Nordisk Investigational Site | Brussels | |
| Belgium | Novo Nordisk Investigational Site | Bruxelles | |
| Belgium | Novo Nordisk Investigational Site | Gent | |
| Belgium | Novo Nordisk Investigational Site | Huy | |
| Belgium | Novo Nordisk Investigational Site | Leuven | |
| Belgium | Novo Nordisk Investigational Site | Liège | |
| Belgium | Novo Nordisk Investigational Site | Montigny-Le-Tilleul | |
| Belgium | Novo Nordisk Investigational Site | Watermael-Boifort | |
| Denmark | Novo Nordisk Investigational Site | Allerød | |
| Denmark | Novo Nordisk Investigational Site | Århus C | |
| Denmark | Novo Nordisk Investigational Site | Frederiksberg | |
| Denmark | Novo Nordisk Investigational Site | Hvidovre | |
| Denmark | Novo Nordisk Investigational Site | København N | |
| Denmark | Novo Nordisk Investigational Site | Næstved | |
| Denmark | Novo Nordisk Investigational Site | Odense C | |
| Denmark | Novo Nordisk Investigational Site | Virum | |
| Finland | Novo Nordisk Investigational Site | Espoo | |
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| Finland | Novo Nordisk Investigational Site | Oulu | |
| Finland | Novo Nordisk Investigational Site | Tampere | |
| Finland | Novo Nordisk Investigational Site | Turku | |
| France | Novo Nordisk Investigational Site | Amiens | |
| France | Novo Nordisk Investigational Site | LA ROCHE-sur-YON cedex 9 | |
| France | Novo Nordisk Investigational Site | Marseille | |
| France | Novo Nordisk Investigational Site | MARSEILLE cedex 05 | |
| France | Novo Nordisk Investigational Site | Montpellier | |
| France | Novo Nordisk Investigational Site | MONTPELLIER cedex 05 | |
| France | Novo Nordisk Investigational Site | NANTES cedex 1 | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | Nice | |
| France | Novo Nordisk Investigational Site | Nimes | |
| France | Novo Nordisk Investigational Site | NIMES cedex 9 | |
| France | Novo Nordisk Investigational Site | TOULOUSE cedex 9 | |
| Germany | Novo Nordisk Investigational Site | Jessen | |
| Germany | Novo Nordisk Investigational Site | Karlsruhe | |
| Germany | Novo Nordisk Investigational Site | Leipzig | |
| Germany | Novo Nordisk Investigational Site | Lorsch | |
| Germany | Novo Nordisk Investigational Site | Rheine | |
| Germany | Novo Nordisk Investigational Site | Rheinstetten | |
| Germany | Novo Nordisk Investigational Site | Schorndorf | |
| Germany | Novo Nordisk Investigational Site | Stuttgart | |
| Germany | Novo Nordisk Investigational Site | Tübingen | |
| Germany | Novo Nordisk Investigational Site | Völklingen | |
| Norway | Novo Nordisk Investigational Site | Grålum | |
| Norway | Novo Nordisk Investigational Site | Hamar | |
| Norway | Novo Nordisk Investigational Site | Kolbotn | |
| Norway | Novo Nordisk Investigational Site | Lillestrøm | |
| Norway | Novo Nordisk Investigational Site | Oslo | |
| Norway | Novo Nordisk Investigational Site | Paradis | |
| Norway | Novo Nordisk Investigational Site | Stavanger | |
| Norway | Novo Nordisk Investigational Site | Stavanger | |
| Norway | Novo Nordisk Investigational Site | Trondheim | |
| Sweden | Novo Nordisk Investigational Site | Göteborg | |
| Sweden | Novo Nordisk Investigational Site | Göteborg | |
| Sweden | Novo Nordisk Investigational Site | Linköping | |
| Sweden | Novo Nordisk Investigational Site | Linköping | |
| Sweden | Novo Nordisk Investigational Site | Lund | |
| Sweden | Novo Nordisk Investigational Site | Malmö | |
| Sweden | Novo Nordisk Investigational Site | Norrköping | |
| Sweden | Novo Nordisk Investigational Site | Uppsala | |
| Switzerland | Novo Nordisk Investigational Site | Bulle | |
| Switzerland | Novo Nordisk Investigational Site | Frauenfeld | |
| Switzerland | Novo Nordisk Investigational Site | Weinfelden | |
| Switzerland | Novo Nordisk Investigational Site | Zürich | |
| Switzerland | Novo Nordisk Investigational Site | Zürich | |
| United Kingdom | Novo Nordisk Investigational Site | Aldershot | |
| United Kingdom | Novo Nordisk Investigational Site | Bexhill-on-Sea | |
| United Kingdom | Novo Nordisk Investigational Site | Birmingham | |
| United Kingdom | Novo Nordisk Investigational Site | Bolton | |
| United Kingdom | Novo Nordisk Investigational Site | Chesterfield, Derbyshire | |
| United Kingdom | Novo Nordisk Investigational Site | Chippenham | |
| United Kingdom | Novo Nordisk Investigational Site | Cornwell | |
| United Kingdom | Novo Nordisk Investigational Site | Coventry | |
| United Kingdom | Novo Nordisk Investigational Site | Devon | |
| United Kingdom | Novo Nordisk Investigational Site | Hastings | |
| United Kingdom | Novo Nordisk Investigational Site | Hull | |
| United Kingdom | Novo Nordisk Investigational Site | Linclolshire | |
| United Kingdom | Novo Nordisk Investigational Site | Liverpool | |
| United Kingdom | Novo Nordisk Investigational Site | London | |
| United Kingdom | Novo Nordisk Investigational Site | London | |
| United Kingdom | Novo Nordisk Investigational Site | London | |
| United Kingdom | Novo Nordisk Investigational Site | Manchester | |
| United Kingdom | Novo Nordisk Investigational Site | Norfolk | |
| United Kingdom | Novo Nordisk Investigational Site | Oxford | |
| United Kingdom | Novo Nordisk Investigational Site | Reading | |
| United Kingdom | Novo Nordisk Investigational Site | Sheffield | |
| United Kingdom | Novo Nordisk Investigational Site | Stoke on Trent | |
| United Kingdom | Novo Nordisk Investigational Site | Suffolk | |
| United Kingdom | Novo Nordisk Investigational Site | WAtford |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Austria, Belgium, Denmark, Finland, France, Germany, Norway, Sweden, Switzerland, United Kingdom,
Lundström E, Bygdeson M, Svane G, Azavedo E, von Schoultz B. Neutral effect of ultra-low-dose continuous combined estradiol and norethisterone acetate on mammographic breast density. Climacteric. 2007 Jun;10(3):249-56. — View Citation
Panay N, Ylikorkala O, Archer DF, Gut R, Lang E. Ultra-low-dose estradiol and norethisterone acetate: effective menopausal symptom relief. Climacteric. 2007 Apr;10(2):120-31. — View Citation
Sturdee DW, Archer DF, Rakov V, Lang E; CHOICE Study Investigators.. Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women. Climacteric. 2008 Feb;11(1):63-73. doi: 10.1080/13697130701852 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in mean number of moderate to severe hot flushes per week | At week 8 | ||
| Secondary | Urogenital symptoms | Week 0; week 24 | ||
| Secondary | Vaginal cytology and pH | Week 0; week 24 | ||
| Secondary | Bleeding profile | Week 0; week 24 | ||
| Secondary | Adverse Events | Week 0; week 24 | ||
| Secondary | Menopausal symptoms and quality of life (Greene Climacteric Scale) | Week 0; week 24 | ||
| Secondary | Hot flush weekly weighted score | Week 0; week 24 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04553029 -
A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
|
||
| Completed |
NCT03672513 -
Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause
|
N/A | |
| Terminated |
NCT03642119 -
Validation of an Objective Instrument to Measure Hot Flashes During Menopause
|
||
| Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
| Completed |
NCT04210583 -
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
|
N/A | |
| Completed |
NCT06057896 -
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
|
||
| Completed |
NCT05617287 -
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
|
N/A | |
| Recruiting |
NCT05180266 -
Therapeutic Touch and Music in The Menopausal Period
|
N/A | |
| Recruiting |
NCT04043520 -
Bioenergetic Effects of Aging and Menopause (BEAM)
|
Phase 4 | |
| Completed |
NCT03663075 -
Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
|
N/A | |
| Completed |
NCT03363997 -
Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days
|
Phase 1 | |
| Not yet recruiting |
NCT04724135 -
Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
|
||
| Not yet recruiting |
NCT04728126 -
Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
|
||
| Completed |
NCT02274571 -
Raising Insulin Sensitivity in Post Menopause
|
Early Phase 1 | |
| Completed |
NCT02253173 -
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
|
Phase 3 | |
| Completed |
NCT02430987 -
Low Sexual Desire and Metabolic Syndrome
|
N/A | |
| Completed |
NCT01757340 -
Calorie Restriction With Leucine Supplementation
|
N/A | |
| Recruiting |
NCT01488903 -
A Cohort Research of Genetic Susceptibility for Common Obesity in Women
|
N/A | |
| Terminated |
NCT01633814 -
Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women
|
N/A | |
| Completed |
NCT00599456 -
Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.
|
N/A |