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Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile

NCT01123538 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-11-03

No results posted yet for this study

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

Interventions

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

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)

Sponsors & Collaborators

  • University Hospital of North Norway

    lead OTHER

Principal Investigators

  • Eiliv Lund, MD, PhD · Institute of Community Medicine, Tromsø, Norway

  • Vanessa Dumeaux, PharmD, PhD · Institute of community medicine, Tromsø, Norway

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-10-31
Completion
2012-10-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01123538 on ClinicalTrials.gov