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

Menopausal Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822288
• Other study ID #: 101080-F
• Status: Completed
• Phase: Phase 4
• Start date: November 16, 2012
• Est. completion date: August 26, 2021

Study information

• Verified date: December 2021
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: August 26, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients with gynecologic or breast cancers

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Menopausal Syndromes
• Psychophysiologic Disorders
• Somatoform Disorders

Intervention

Drug:
• Tibolone
Tibolone 2.5 mg once a day for patients with menopausal syndrome (self-paid)
• Estradiol & medroxyprogesterone acetate
Estradiol & medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Banqiao	New Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menopausal symptoms	To clarify any difference of reduction in menopausal symptom scores between these two groups	12 weeks
Secondary	sexual function	To clarify any difference of improvements of sexual function scores between these two groups	12 weeks
Secondary	lower urinary tract symptoms	To clarify any difference of improvements of lower urinary tract symptoms scores between these two groups	12 weeks
Secondary	psychosomatic symptoms	To clarify any difference of improvements of psychosomatic symptoms scores between these two groups	12 weeks