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Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile

NCT ID: NCT01123538

Last Updated: 2011-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pharmacogenomics Systems Biology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Natural progesterone

Combined menopausal treatment containing natural progesterone

Group Type OTHER

Progesterone

Intervention Type DRUG

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

Chlormadinone acetate

Combined menopausal treatment containing chlormadinone acetate

Group Type ACTIVE_COMPARATOR

Chlormadinone acetate

Intervention Type DRUG

5 mg/day oral chlormadinone acetate (e.g. Luteran® 5mg)+ 0.05 mg/day transdermal (i.e. plaster) 17β-estradiol (e.g. Estraderm® 50µg)

Interventions

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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

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eiliv Lund, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Community Medicine, Tromsø, Norway

Vanessa Dumeaux, PharmD, PhD

Role: STUDY_DIRECTOR

Institute of community medicine, Tromsø, Norway

Locations

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Gynecology center, Helse Nord

Bodø, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2006-004462-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EudraCT-2006-004462-14

Identifier Type: -

Identifier Source: org_study_id