Clinical trial NCT01123538: Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile
Official title: Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pharmacogenomics
Systems Biology
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Whole blood and white blood cells gene expression profiling after 3 months of HT treatment
timeFrame: 0 and 3 months after treatment
Secondary outcomes:
measure: Quality of life, proteome, plasma haemostatic variable measurements
timeFrame: 0,3,6 and 12 months
measure: Whole blood and white blood cells gene expression profiling after 12 months of HT treatment
timeFrame: 0 and 12 months after treatment
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Gynecology center, Helse Nord
Study officials:
affiliation: Institute of Community Medicine, Tromsø, Norway
name: Eiliv Lund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of community medicine, Tromsø, Norway
name: Vanessa Dumeaux, PharmD, PhD
role: STUDY_DIRECTOR
References: