Status:
TERMINATED
Climacteric Therapy With Applied Relaxation Using InterNet
Lead Sponsor:
Mats Hammar
Collaborating Sponsors:
Linkoeping University
Conditions:
Hot Flashes
Menopause
Eligibility:
FEMALE
45+ years
Phase:
NA
Brief Summary
The aim is to evaluate effects of internet-based applied relaxation (a simplified version of cognitive behavioral therapy) for women with menopausal symptoms mainly vasomotoric symptom (VMS), i.e. hot...
Detailed Description
See above
Eligibility Criteria
Inclusion
- A minimum of 7 moderate or severe hot flashes per 24 h or 50 hot flashes per week in average at least during one week before randomization (mild = hot flash without sweating as recognized by the woman but not disturbing the woman, moderate = hot flash and sweating as recognized by the woman but that does not lead to disruption of ongoing activity, severe = hot flash with sweating that leads to disruption of ongoing activity)
- Natural menopause (at least 12 months without any menstrual bleedings at all)
- At least 45 years of age during present year
- Access to computer with Internet
- Ability to read and speak Swedish
- Freely informed concent for participation
Exclusion
- Induced menopause (e.g. hysterectomy, oophorectomy, chemotherapy, radiation therapy over abdominal- and/or pelvic region)
- Early or premature menopause (before 45 years of age)
- Breastcancer disease with ongoing therapy with antiestrogen or aromatase inhibitors
- Ongoing usage or use during the last month of hormone therapy or other treatment aimed for hot flashes (e.g. natural remedies affecting hot flashes, acupuncture, dietary supplements aimed to treat hot flashes
- Treatment with psychopharmacological drugs (e.g SSRI or SNRI) or frequent use of benzodiazepines, drugs for insomnia(\> 1 times/week)
- Untreated or unstable endocrinological- or metabolic disease( e.g thyroid disease)
- Undiagnosed vaginal bleeding after menopause
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01245907
Start Date
February 1 2011
End Date
October 1 2012
Last Update
April 25 2014
Active Locations (1)
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1
County Council of Östergötland, Kvinnokliniken
Linköping, Sweden, 581 85