Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile

Pharmacogenomics Clinical Trial

— ProGEP  

Official title:

Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01123538
• Other study ID #: EudraCT-2006-004462-14
• Secondary ID: 2006-004462-14
• Status: Unknown status
• Phase: Phase 4
• First received: April 30, 2010
• Last updated: November 2, 2011
• Start date: December 2008
• Est. completion date: October 2012

Study information

• Verified date: November 2011
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacogenomics
• Systems Biology

Intervention

Drug:
• Progesterone
200 mg/day oral micronized natural progesterone (e.g. Utrogestan® 100mg) + 0.05 mg/day transdermal (i.e. plaster) 17ß-estradiol (e.g. Estraderm® 50µg) during a year
• Chlormadinone acetate
5 mg/day oral chlormadinone acetate (e.g. Luteran® 5mg)+ 0.05 mg/day transdermal (i.e. plaster) 17ß-estradiol (e.g. Estraderm® 50µg)

Locations

Country	Name	City	State
Norway	Gynecology center, Helse Nord	Bodø

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole blood and white blood cells gene expression profiling after 3 months of HT treatment		0 and 3 months after treatment
Secondary	Quality of life, proteome, plasma haemostatic variable measurements		0,3,6 and 12 months
Secondary	Whole blood and white blood cells gene expression profiling after 12 months of HT treatment		0 and 12 months after treatment