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

NCT ID: NCT01822288

Last Updated: 2022-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-16

Study Completion Date

2021-08-26

Brief Summary

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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

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Conditions

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Menopausal Syndromes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tibolone

Intervention Type DRUG

Tibolone 2.5 mg once a day for patients with menopausal syndrome (self-paid)

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.

Group Type ACTIVE_COMPARATOR

Estradiol & medroxyprogesterone acetate

Intervention Type DRUG

Estradiol \& medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug

Interventions

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Tibolone

Tibolone 2.5 mg once a day for patients with menopausal syndrome (self-paid)

Intervention Type DRUG

Estradiol & medroxyprogesterone acetate

Estradiol \& medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients with gynecologic or breast cancers
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Far Eastern Memorial Hospital

Banqiao District, New Taipei, Taiwan

Site Status

Countries

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Taiwan

References

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Hsiao SM, Liao SC. Effect of tibolone vs hormone replacement therapy on climacteric symptoms and psychological distress. J Chin Med Assoc. 2024 Feb 1;87(2):189-195. doi: 10.1097/JCMA.0000000000001012. Epub 2023 Oct 26.

Reference Type DERIVED
PMID: 37882059 (View on PubMed)

Other Identifiers

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101080-F

Identifier Type: -

Identifier Source: org_study_id

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