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

Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression

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.

Study Overview

• Status: Unknown
• Conditions: Pharmacogenomics; Systems Biology
• Intervention / Treatment: Drug: Progesterone; Drug: Chlormadinone acetate

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Bodø, Norway
    • Gynecology center, Helse Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Whole blood and white blood cells gene expression profiling after 3 months of HT treatment	0 and 3 months after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): October 1, 2011
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: May 12, 2010
• First Posted (Estimate): May 14, 2010

Study Record Updates

• Last Update Posted (Estimate): November 3, 2011
• Last Update Submitted That Met QC Criteria: November 2, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Androgen Antagonists; Progestins; Progesterone; Chlormadinone Acetate
• Other Study ID Numbers: EudraCT-2006-004462-14; 2006-004462-14 (EudraCT Number)