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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01822288

Enrollment

125

Registered

2013-04-02

Start date

2012-11-16

Completion date

2021-08-26

Last updated

2022-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopausal Syndromes

Keywords

Menopause, Tibolone, Estradiol, Hormone therapy

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.

Interventions

DRUGTibolone

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

DRUGEstradiol & medroxyprogesterone acetate

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* patients with gynecologic or breast cancers

Design outcomes

Primary

Measure	Time frame	Description
Menopausal symptoms	12 weeks	To clarify any difference of reduction in menopausal symptom scores between these two groups

Secondary

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026