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

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ClinicalTrials.gov Identifier: NCT01123538
Recruitment Status : Unknown
Verified November 2011 by University Hospital of North Norway.
Recruitment status was:  Active, not recruiting
First Posted : May 14, 2010
Last Update Posted : November 3, 2011
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
Estimated 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 : December 2008
Primary Completion Date : October 2011
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 :
  1. Whole blood and white blood cells gene expression profiling after 3 months of HT treatment [ Time Frame: 0 and 3 months after treatment ]

Secondary Outcome Measures :
  1. Quality of life, proteome, plasma haemostatic variable measurements [ Time Frame: 0,3,6 and 12 months ]
  2. Whole blood and white blood cells gene expression profiling after 12 months of HT treatment [ Time Frame: 0 and 12 months after treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123538


Locations
Norway
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
More Information

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01123538     History of Changes
Other Study ID Numbers: EudraCT-2006-004462-14
2006-004462-14 ( EudraCT Number )
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: November 3, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Hormones
Progesterone
Progestins
Chlormadinone Acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents