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

• Conditions: Menopause and female climacteric states; MedDRA version: 8.1Level: LLTClassification code 10027308Term: Menopause

• Registration Number: EUCTR2005-004427-19-DE
• Lead Sponsor: udwig-Maximilians-Universitaet Muenchen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-01
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Women who:
- 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
- or who are participating in another clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the withdrawal effect from long-term (>=3 years) postmenopausal HT. Measures on health-related QoL and psychological well-being among women aged 55 to 69 will be taken.;Secondary Objective: Evaluation of the withdrawal effects from HT in: vasomotor, somatic and psychological symptoms, libido, sleep quality, anxiety and depression symptoms and life satisfaction.;Primary end point(s): Mean scores of health-related quality of life questionnaire 6 months after baseline as measured with the Medical Outcomes Study 36-item Short Form General Health Survey (SF-36).