Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile

NCT01123538 | Unknown Phase 4

• 2 other identifiers: EudraCT-2006-004462-142006-004462-14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacogenomics; Systems Biology

Outcome Measures

Primary Outcomes (1)

• Whole blood and white blood cells gene expression profiling after 3 months of HT treatment

  0 and 3 months after treatment

Secondary Outcomes (2)

• 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

Study Arms (2)

Natural progesterone

OTHER

Combined menopausal treatment containing natural progesterone

Drug: Progesterone

Chlormadinone acetate

ACTIVE COMPARATOR

Combined menopausal treatment containing chlormadinone acetate

Drug: Chlormadinone acetate

Interventions

Progesterone 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

Natural progesterone

Chlormadinone acetate 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)

Chlormadinone acetate

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women defined as:
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

Gynecology center, Helse Nord

Bodø, Norway

Location

MeSH Terms

Interventions

Progesterone; Chlormadinone Acetate

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Pregnadienes; Steroids, Chlorinated

Study Officials

• Eiliv Lund, MD, PhD

  Institute of Community Medicine, Tromsø, Norway

  PRINCIPAL INVESTIGATOR

• Vanessa Dumeaux, PharmD, PhD

  Institute of community medicine, Tromsø, Norway

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 14, 2010
• Study Start: December 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: November 3, 2011

Record last verified: 2011-11

Locations

NO (1)