Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile
This trial is active, not recruiting.
|Conditions||pharmacogenomics, systems biology|
|Treatments||progesterone, chlormadinone acetate|
|Sponsor||University Hospital of North Norway|
|Start date||December 2008|
|End date||October 2011|
|Trial size||40 participants|
|Trial identifier||NCT01123538, 2006-004462-14, EudraCT-2006-004462-14|
The purpose of this study is to compare combined postmenopausal hormone therapy natural progesterone to the one containing synthetic progestagen (i.e. chlormadinone acetate) at the blood transcriptome level.
|Intervention model||parallel assignment|
Whole blood and white blood cells gene expression profiling after 3 months of HT treatment
time frame: 0 and 3 months after treatment
Quality of life, proteome, plasma haemostatic variable measurements
time frame: 0,3,6 and 12 months
Whole blood and white blood cells gene expression profiling after 12 months of HT treatment
time frame: 0 and 12 months after treatment
Female participants from 45 years up to 65 years old.
Inclusion Criteria: - Postmenopausal women defined as: - 45 years< age < 65 years - Amenorrhoeic for ≥ 1 year - Amenorrhoeic for < 1 year either without any withdrawal vaginal bleeding for 3 consecutive months in spite of a cyclic progestagen treatment and/or blood estradiol levels ≤ 20 pg/mL and blood FSH levels ≥ 40 UI/mL - Women with bilateral ovariectomy - Women suffering of at least 1 postmenopausal symptoms listed: - Hot flashes, - Memory and Concentration Problems, - Mood Swings, - Insomnia, - Urinary Incontinence, - Night sweating, - Join pains, - Asthenia. - No use of hormone therapy (HT) - Previous HT user: - HT use < 3 months - stop for 6 months - HT use <= 1 year - stop for > 12 months - If previous use of soya derivatives in dietary supplements: washout period = 3 months - Signed informed consent, after having received both oral- and written- information regarding the study goals, its risks and benefits and its constraints, including the 12 month follow-up. A delay should be respected between information and the signature of the written consent. Exclusion Criteria: - Past HT users who have used treatment for more than 1 year - Hysterectomized women - Women without health insurance (only in French centre) - History of cardio-vascular accident either arterial or venous - Untreated high blood pressure - Liver disease - Diabetes - History of cancer except basal-cell skin cancer and colon cancer - Severe history of familial breast cancer defined as at least 2 women first degree- relatives with breast cancer diagnosis before 50 years - History of severe mastalgia - History of breast biopsy showing hyperplasia (with or without atypia) - Undiagnosed vaginal bleeding - Diagnosed endometrial hyperplasia - Auto-immune disease (e.g. lupus) - Women with kidney transplant
|Official title||Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression|
|Principal investigator||Eiliv Lund, MD, PhD|
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