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

This study is currently recruiting participants.
Verified September 2016 by Sheng-Mou Hsiao, Far Eastern Memorial Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01822288
First Posted: April 2, 2013
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheng-Mou Hsiao, Far Eastern Memorial Hospital
  Purpose

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.


Condition Intervention Phase
Menopausal Syndromes Drug: Tibolone Drug: Estradiol & medroxyprogesterone acetate Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Different Hormone Therapy Regimens on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder

Resource links provided by NLM:


Further study details as provided by Sheng-Mou Hsiao, Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • Menopausal symptoms [ Time Frame: 12 weeks ]
    To clarify any difference of reduction in menopausal symptom scores between these two groups


Secondary Outcome Measures:
  • sexual function [ Time Frame: 12 weeks ]
    To clarify any difference of improvements of sexual function scores between these two groups

  • lower urinary tract symptoms [ Time Frame: 12 weeks ]
    To clarify any difference of improvements of lower urinary tract symptoms scores between these two groups

  • psychosomatic symptoms [ Time Frame: 12 weeks ]
    To clarify any difference of improvements of psychosomatic symptoms scores between these two groups


Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Tibolone
Tibolone 2.5 mg once a day for patients with menopausal syndrome (self-paid)
Active Comparator: 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.
Drug: Estradiol & medroxyprogesterone acetate
Estradiol & medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822288


Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
Banqiao Dist., New Taipei, Taiwan, 220
Contact: Sheng-Mou Hsiao, M.D.    +886-2-89667000 ext 1424    smhsiao2@gmail.com   
Principal Investigator: Sheng-Mou Hsiao, M.D.         
Sponsors and Collaborators
Far Eastern Memorial Hospital
  More Information

Responsible Party: Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01822288     History of Changes
Other Study ID Numbers: 101080-F
First Submitted: November 26, 2012
First Posted: April 2, 2013
Last Update Posted: February 10, 2017
Last Verified: September 2016

Keywords provided by Sheng-Mou Hsiao, Far Eastern Memorial Hospital:
Menopause
Tibolone
Estradiol
Hormone therapy

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Psychophysiologic Disorders
Urological Manifestations
Signs and Symptoms
Neurologic Manifestations
Hormones
Estradiol
Polyestradiol phosphate
Tibolone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Medroxyprogesterone
Medroxyprogesterone Acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Antihypertensive Agents
Estrogen Receptor Modulators
Anabolic Agents