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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Menopausal Syndromes	Drug: Tibolone; Drug: Estradiol & medroxyprogesterone acetate	Phase 4

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
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
Study Start Date :	December 2012
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	June 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Menopausal symptoms [ Time Frame: 12 weeks ]
   To clarify any difference of reduction in menopausal symptom scores between these two groups

Secondary Outcome Measures :

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

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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:

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Lower Urinary Tract Symptoms; Psychophysiologic Disorders; Urological Manifestations; Signs and Symptoms; Neurologic Manifestations; Estradiol; Polyestradiol phosphate; Tibolone; Estradiol 3-benzoate; Estradiol 17 beta-cypionate; Estradiol valerate; Medroxyprogesterone	Medroxyprogesterone Acetate; 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; Antihypertensive Agents; Estrogen Receptor Modulators; Anabolic Agents