Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile

• Status: Unknown status
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital of North Norway
• Treatments: Chlormadinone Acetate; Hormones; Progesterone; Progestins

Criteria

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