Back to resultsThe Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder
Primary Purpose
Menopausal Syndromes
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Tibolone
Estradiol & medroxyprogesterone acetate
Sponsored by
About this trial
This is an interventional treatment trial for Menopausal Syndromes focused on measuring Menopause, Tibolone, Estradiol, Hormone therapy
Eligibility Criteria
Inclusion Criteria:
- All female patients with intact uterus who seek for medical treatment for menopausal syndrome
Exclusion Criteria:
- patients with gynecologic or breast cancers
Sites / Locations
- Far Eastern Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tibolone group
Conventional hormone therapy group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Menopausal symptoms
To clarify any difference of reduction in menopausal symptom scores between these two groups
Secondary Outcome Measures
sexual function
To clarify any difference of improvements of sexual function scores between these two groups
lower urinary tract symptoms
To clarify any difference of improvements of lower urinary tract symptoms scores between these two groups
psychosomatic symptoms
To clarify any difference of improvements of psychosomatic symptoms scores between these two groups
Full Information
NCT ID
NCT01822288
First Posted
November 26, 2012
Last Updated
February 7, 2022
Sponsor
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01822288
Brief Title
The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder
Official Title
The Impact of Different Hormone Therapy Regimens on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 16, 2012 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
August 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Far Eastern Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopausal Syndromes
Keywords
Menopause, Tibolone, Estradiol, Hormone therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tibolone group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional hormone therapy group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tibolone
Intervention Description
Tibolone 2.5 mg once a day for patients with menopausal syndrome (self-paid)
Intervention Type
Drug
Intervention Name(s)
Estradiol & medroxyprogesterone acetate
Intervention Description
Estradiol & medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug
Primary Outcome Measure Information:
Title
Menopausal symptoms
Description
To clarify any difference of reduction in menopausal symptom scores between these two groups
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
sexual function
Description
To clarify any difference of improvements of sexual function scores between these two groups
Time Frame
12 weeks
Title
lower urinary tract symptoms
Description
To clarify any difference of improvements of lower urinary tract symptoms scores between these two groups
Time Frame
12 weeks
Title
psychosomatic symptoms
Description
To clarify any difference of improvements of psychosomatic symptoms scores between these two groups
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All female patients with intact uterus who seek for medical treatment for menopausal syndrome
Exclusion Criteria:
patients with gynecologic or breast cancers
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Banqiao
State/Province
New Taipei
ZIP/Postal Code
220
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder
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