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

February 7, 2022 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • New Taipei
      • Banqiao, New Taipei, Taiwan, 220
        • Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 16, 2012

Primary Completion (ACTUAL)

July 8, 2021

Study Completion (ACTUAL)

August 26, 2021

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

April 1, 2013

First Posted (ESTIMATE)

April 2, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101080-F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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