Pharmacogenomics, Systems Biology
Conditions
Brief summary
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.
Interventions
DRUGProgesterone
200 mg/day oral micronized natural progesterone (e.g. Utrogestan® 100mg) + 0.05 mg/day transdermal (i.e. plaster) 17β-estradiol (e.g. Estraderm® 50µg) during a year
DRUGChlormadinone acetate
5 mg/day oral chlormadinone acetate (e.g. Luteran® 5mg)+ 0.05 mg/day transdermal (i.e. plaster) 17β-estradiol (e.g. Estraderm® 50µg)
Sponsors
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whole blood and white blood cells gene expression profiling after 3 months of HT treatment | 0 and 3 months after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life, proteome, plasma haemostatic variable measurements | 0,3,6 and 12 months |
| Whole blood and white blood cells gene expression profiling after 12 months of HT treatment | 0 and 12 months after treatment |
Countries
Norway
Outcome results
None listed