Trial record 1 of 29 for: (menopause OR postmenopause) [CONDITION ] ((hormone therapy) OR HRT) [TREATMENT ] | Open Studies

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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. (see Contacts and Locations)

Verified September 2016 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: September 4, 2016

Last verified: September 2016

History of Changes

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:

MedlinePlus related topics: Hormones Menopause Urine and Urination

Drug Information available for: Estradiol Medroxyprogesterone acetate Estradiol cypionate Estradiol valerate Estradiol acetate Estradiol hemihydrate

U.S. FDA Resources

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:	June 2017
Estimated Primary Completion Date:	November 2016 (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 (Adult, Senior)
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


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:	September 4, 2016
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by 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 Acetate	Medroxyprogesterone Physiological Effects of Drugs Estrogens Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Androgen Antagonists Antihypertensive Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Estrogen Receptor Modulators Anabolic Agents Contraceptive Agents, Male Contraceptives, Oral, Synthetic Contraceptives, Oral

ClinicalTrials.gov processed this record on September 26, 2016

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