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Clinical Trials/EUCTR2005-004427-19-DE
EUCTR2005-004427-19-DE
Active, Not Recruiting
N/A

Health-related quality of life (QoL) and psychological well-being after withdrawal from hormone therapy (HT). A randomised double-blind placebo-controlled trial. - Quality of life after withdrawal from HT

udwig-Maximilians-Universitaet Muenchen0 sitesSeptember 1, 2006
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ConditionsMenopause and female climacteric statesMedDRA version: 8.1Level: LLTClassification code 10027308Term: Menopause
DrugsPresomen® 0,6/5 mg compositumPresomen® 28 compositum 0.3 mg/ 5 mgPresomen® 28 compositum 0,3 mg/ 5 mg

Overview

Phase
N/A
Intervention
Not specified
Conditions
Menopause and female climacteric states
Sponsor
udwig-Maximilians-Universitaet Muenchen
Status
Active, Not Recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 1, 2006
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
udwig-Maximilians-Universitaet Muenchen

Eligibility Criteria

Inclusion Criteria

  • •Women aged 55 to 69:
  • •\- who are on menopausal HT for at least three years
  • •\- who are currently taking Presomen® 0\.6mg/ 5mg compositum or Presomen® 28 compositum 0\.3 mg/5 mg
  • •\- who have good knowledge of German for filling in the questionnaires
  • •\- who have had a mammography in the last year or will have one before starting intake of medication
  • •\- who have signed the informed consent
  • •\- who intend to continue on HT for at least 6 months
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •\- have had hysterectomy
  • •\- who have known, suspected, or history of breast cancer
  • •\- who have history or existing venous thromboembolism
  • •\- who have had previous acute heart disease or stroke
  • •\- who have active or history of liver dysfunction or disease
  • •\- who have known or suspected estrogen\-dependent neoplasia (particularly cancer of the endometrium)
  • •\- who have untreated endometrial hyperplasia
  • •\- who have undiagnosed abnormal genital bleeding
  • •\- who have porphyry
  • •\- who have terminal renal insufficiency

Outcomes

Primary Outcomes

Not specified

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