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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Far Eastern Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Sheng-Mou Hsiao, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01822288
First received: November 26, 2012
Last updated: November 13, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • Menopausal symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To clarify any difference of reduction in menopausal symptom scores between these two groups


Secondary Outcome Measures:
  • sexual function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To clarify any difference of improvements of sexual function scores between these two groups

  • lower urinary tract symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To clarify any difference of improvements of lower urinary tract symptoms scores between these two groups

  • psychosomatic symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   40 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 26, 2012
Last Updated: November 13, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by 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 valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Medroxyprogesterone
Medroxyprogesterone Acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estrogens
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Antihypertensive Agents

ClinicalTrials.gov processed this record on September 18, 2014