The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder
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|ClinicalTrials.gov Identifier: NCT01822288|
Recruitment Status : Recruiting
First Posted : April 2, 2013
Last Update Posted : February 10, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Menopausal Syndromes||Drug: Tibolone Drug: Estradiol & medroxyprogesterone acetate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Different Hormone Therapy Regimens on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
Experimental: 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 2.5 mg once a day for patients with menopausal syndrome (self-paid)
Active Comparator: 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.
Drug: Estradiol & medroxyprogesterone acetate
Estradiol & medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug
- Menopausal symptoms [ Time Frame: 12 weeks ]To clarify any difference of reduction in menopausal symptom scores between these two groups
- sexual function [ Time Frame: 12 weeks ]To clarify any difference of improvements of sexual function scores between these two groups
- lower urinary tract symptoms [ Time Frame: 12 weeks ]To clarify any difference of improvements of lower urinary tract symptoms scores between these two groups
- psychosomatic symptoms [ Time Frame: 12 weeks ]To clarify any difference of improvements of psychosomatic symptoms scores between these two groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822288
|Far Eastern Memorial Hospital||Recruiting|
|Banqiao Dist., New Taipei, Taiwan, 220|
|Contact: Sheng-Mou Hsiao, M.D. +886-2-89667000 ext 1424 email@example.com|
|Principal Investigator: Sheng-Mou Hsiao, M.D.|