The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder

Study Overview
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Brief Summary
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Menopausal syndromes includes somatic symptom, psychosomatic symptoms, sexual dysfunction and even urinary symptoms. Hormone therapy (HT) is widely used for controlling menopausal symptoms. Common HT for menopausal syndrome with intact uterus includes tibolone, estradiol valerate (E2V) 1mg & medroxyprogesterone acetate (MPA) 2.5 mg, and conjugated equine estrogens & MPA. 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.

Official Title
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The Impact of Different Hormone Therapy Regimens on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder

Conditions
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Menopausal Syndromes

Intervention / Treatment
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* Drug: Tibolone
* Drug: Estradiol & medroxyprogesterone acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All female patients with intact uterus who seek for medical treatment for menopausal syndrome Exclusion Criteria: patients with gynecologic or breast cancers

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tibolone group<br>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. | Drug: Tibolone<br>* Tibolone 2.5 mg once a day for patients with menopausal syndrome (self-paid)<br>|
| Active Comparator: Conventional hormone therapy group<br>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. | Drug: Estradiol & medroxyprogesterone acetate<br>* Estradiol & medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menopausal symptoms | To clarify any difference of reduction in menopausal symptom scores between these two groups | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sexual function | To clarify any difference of improvements of sexual function scores between these two groups | 12 weeks | 
| lower urinary tract symptoms | To clarify any difference of improvements of lower urinary tract symptoms scores between these two groups | 12 weeks | 
| psychosomatic symptoms | To clarify any difference of improvements of psychosomatic symptoms scores between these two groups | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, Tibolone, Estradiol, Hormone therapy