HRT on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness
NCT ID: NCT05280028
Last Updated: 2024-06-17
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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RECRUITING
100 participants
OBSERVATIONAL
2022-02-07
2026-12-31
Brief Summary
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From the results, the investigators will compare the effect of tibolone versus E2V/MPA on overactive bladder symptoms, sexual function, autonomic function, arterial stiffness, atherosclerosis, sleep and depression.
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Detailed Description
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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 overactive bladder symptoms, sexual function, heart rate variability, arterial stiffness, atherosclerosis, sleep and depression. 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 overactive bladder symptoms, sexual function, heart rate variability and arterial stiffness between tibolone and E2V/MPA.
All female patients with intact uterus who underwent treatment for menopausal syndrome at Far Eastern Memorial Hospital from October 2021 will be included. An open-labeled, prospective, comparative study design will be used. HT included tibolone (2.5 mg/day) or E2V (1mg) \& MPA (2.5 mg) per day. The enrolled women will be requested to complete the Greene climacteric scale, Urgency Severity Scale, Overactive Bladder Symptom Score, the International Prostate Symptom Score (IPSS), the Female Sexual Function Index (FSFI), the Pittsburgh Sleep Quality Index, Center for Epidemiological Studies Depression questionnaire, heart rate variability, arterial stiffness and atherosclerosis examinations at baseline, and 4 weeks (visit 2) and 12 weeks (visit 3) after treatment.
From the results, the investigators will compare the effect of tibolone versus E2V/MPA on overactive bladder symptoms, sexual function, autonomic function, arterial stiffness, atherosclerosis, sleep and depression. Currently, there is no similar research as our current study.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Tibolone
Tibolone 2.5 mg per day
Tibolone 2.5 mg
Tibolone 2.5 mg per day
Indivina
Estradiol valerate (E2V) 1mg \& medroxyprogesterone acetate 2.5 mg (MPA) per day
Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg
Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg per day
Interventions
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Tibolone 2.5 mg
Tibolone 2.5 mg per day
Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg
Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Menopausal symptoms, still have a uterus, and no breast or other cancers, and no vascular-blocking disease such as stroke.
Exclusion Criteria
20 Years
FEMALE
No
Sponsors
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Far Eastern Memorial Hospital
OTHER
Responsible Party
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Sheng-Mou Hsiao
Chief of Department of Obstetrics & Gynecology
Principal Investigators
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Sheng-Mou Hsiao, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Locations
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Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, New Taipei, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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110262-F
Identifier Type: -
Identifier Source: org_study_id
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