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OpenTrials
Completed

NCT Number: NCT01822288

The Impact of Hormone Therapy 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.

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Key information

Conditions

Menopausal Syndromes

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 220, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients with gynecologic or breast cancers

Treatment and study plan

Tibolone

Drug

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

Estradiol & medroxyprogesterone acetate

Drug

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

Primary outcomes

  1. Menopausal symptoms

    Time frame: 12 weeks

    To clarify any difference of reduction in menopausal symptom scores between these two groups

Secondary outcomes

  1. sexual function

    Time frame: 12 weeks

    To clarify any difference of improvements of sexual function scores between these two groups

  2. lower urinary tract symptoms

    Time frame: 12 weeks

    To clarify any difference of improvements of lower urinary tract symptoms scores between these two groups

  3. psychosomatic symptoms

    Time frame: 12 weeks

    To clarify any difference of improvements of psychosomatic symptoms scores between these two groups

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2013
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.