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

Sponsor

Far Eastern Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01822288

Collaborator

(none)

125

Enrollment

Location

Arms

105.3

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 Design

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 16, 2012

Actual Primary Completion Date :

Jul 8, 2021

Actual Study Completion Date :

Aug 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Tibolone 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

Arm

Intervention/Treatment

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.

Drug: Tibolone

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

Outcome Measures

Primary Outcome Measures

Menopausal symptoms [12 weeks]
To clarify any difference of reduction in menopausal symptom scores between these two groups

Secondary Outcome Measures

sexual function [12 weeks]
To clarify any difference of improvements of sexual function scores between these two groups
lower urinary tract symptoms [12 weeks]
To clarify any difference of improvements of lower urinary tract symptoms scores between these two groups
psychosomatic symptoms [12 weeks]
To clarify any difference of improvements of psychosomatic symptoms scores between these two groups