Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01123538
First received: April 30, 2010
Last updated: November 2, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Pharmacogenomics
Systems Biology
 Drug: Progesterone
Drug: Chlormadinone acetate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Whole blood and white blood cells gene expression profiling after 3 months of HT treatment [ Time Frame: 0 and 3 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life, proteome, plasma haemostatic variable measurements [ Time Frame: 0,3,6 and 12 months ] [ Designated as safety issue: No ]
  • Whole blood and white blood cells gene expression profiling after 12 months of HT treatment [ Time Frame: 0 and 12 months after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2008
Estimated Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 30, 2010
Last Updated: November 2, 2011
Health Authority: Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013