This trial is active, not recruiting.

Conditions pharmacogenomics, systems biology
Treatments progesterone, chlormadinone acetate
Phase phase 4
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Combined menopausal treatment containing natural progesterone
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
(Active Comparator)
Combined menopausal treatment containing chlormadinone acetate
chlormadinone 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)

Primary Outcomes

Whole blood and white blood cells gene expression profiling after 3 months of HT treatment
time frame: 0 and 3 months after treatment

Secondary Outcomes

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

Eligibility Criteria

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

Additional Information

Official title Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression
Principal investigator Eiliv Lund, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by University Hospital of North Norway.