ProGEP: Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile

Sponsor

University Hospital of North Norway (Other)

Overall Status

Unknown status

CT.gov ID

NCT01123538

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacogenomics Systems Biology	Drug: Progesterone Drug: Chlormadinone acetate	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Oct 1, 2011

Anticipated Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Natural progesterone Combined menopausal treatment containing natural progesterone	Drug: 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: Chlormadinone acetate Combined menopausal treatment containing chlormadinone acetate	Drug: 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)

Arm

Intervention/Treatment

Other: Natural progesterone

Combined menopausal treatment containing natural progesterone

Drug: 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: Chlormadinone acetate

Combined menopausal treatment containing chlormadinone acetate

Drug: 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)

Outcome Measures

Primary Outcome Measures

Whole blood and white blood cells gene expression profiling after 3 months of HT treatment [0 and 3 months after treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gynecology center, Helse Nord	Bodø		Norway

Sponsors and Collaborators

University Hospital of North Norway

Investigators

Principal Investigator: Eiliv Lund, MD, PhD, Institute of Community Medicine, Tromsø, Norway
Study Director: Vanessa Dumeaux, PharmD, PhD, Institute of community medicine, Tromsø, Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital of North Norway

ClinicalTrials.gov Identifier:

NCT01123538

Other Study ID Numbers:

EudraCT-2006-004462-14
2006-004462-14

First Posted:

May 14, 2010

Last Update Posted:

Nov 3, 2011

Last Verified:

Nov 1, 2011

Additional relevant MeSH terms:

Chlormadinone Acetate

Progesterone

Study Results

No Results Posted as of Nov 3, 2011