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

Phase 4

Completed

• Conditions: Menopausal Syndromes
• Interventions: Drug: Estradiol & medroxyprogesterone acetate; Drug: Tibolone

• Registration Number: NCT01822288
• Lead Sponsor: Far Eastern Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-16
• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-02
• Primary Completion: 2021-07-08
• Study Completion: 2021-08-26
• Status Verified: 2021-12
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

Inclusion Criteria

• All female patients with intact uterus who seek for medical treatment for menopausal syndrome

Exclusion Criteria

• patients with gynecologic or breast cancers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional hormone therapy group	Estradiol & medroxyprogesterone acetate	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.
Tibolone group	Tibolone	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.

Primary Outcome Measures

Name	Time	Method
Menopausal symptoms	12 weeks	To clarify any difference of reduction in menopausal symptom scores between these two groups

Secondary Outcome Measures

Name	Time	Method
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
sexual function	12 weeks	To clarify any difference of improvements of sexual function scores between these two groups

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan