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

NCT01822288 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2022-02-23

No results posted yet for this study

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.

Conditions

  • Menopausal Syndromes

Interventions

DRUG

Tibolone

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

DRUG

Estradiol & medroxyprogesterone acetate

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

Sponsors & Collaborators

  • Far Eastern Memorial Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-16
Primary Completion
2021-07-08
Completion
2021-08-26

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01822288 on ClinicalTrials.gov