The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder
NCT ID: NCT01822288
Last Updated: 2022-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
125 participants
INTERVENTIONAL
2012-11-16
2021-08-26
Brief Summary
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However, only a few literatures mentioned about the therapeutic effect of tibolone, but lack of comparison research about their therapeutic effect on somatic symptoms, psychosomatic symptoms, sexual dysfunction and even urinary symptoms. The knowledge of the above therapeutic effects should be important for choosing a suitable medication. Therefore, the aim of this study is to assess the therapeutic effect on somatic symptoms, psychosomatic symptoms, sexual dysfunction and even urinary symptoms between tibolone and E2V/MPA.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tibolone group
Tibolone (2.5 mg per day)for 12 consecutive weeks. Tibolone should be paid by patient herself, and does not cover by Taiwan Government health insurance.
Tibolone
Tibolone 2.5 mg once a day for patients with menopausal syndrome (self-paid)
Conventional hormone therapy group
Estradiol valerate (E2V) 1mg \& medroxyprogesterone acetate (MPA) 2.5 mg per day for 12 consecutive weeks, and this drug is paid by Taiwan Government health care insurance.
Estradiol & medroxyprogesterone acetate
Estradiol \& medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug
Interventions
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Tibolone
Tibolone 2.5 mg once a day for patients with menopausal syndrome (self-paid)
Estradiol & medroxyprogesterone acetate
Estradiol \& medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
70 Years
FEMALE
No
Sponsors
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Far Eastern Memorial Hospital
OTHER
Responsible Party
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Sheng-Mou Hsiao
Chief, Department of Obstetrics & Gynecology
Locations
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Far Eastern Memorial Hospital
Banqiao District, New Taipei, Taiwan
Countries
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References
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Hsiao SM, Liao SC. Effect of tibolone vs hormone replacement therapy on climacteric symptoms and psychological distress. J Chin Med Assoc. 2024 Feb 1;87(2):189-195. doi: 10.1097/JCMA.0000000000001012. Epub 2023 Oct 26.
Other Identifiers
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101080-F
Identifier Type: -
Identifier Source: org_study_id
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