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

NCT01822288 | Completed Phase 4

• 1 other identifier: 101080-F
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopausal Syndromes

Keywords

Menopause; Tibolone; Estradiol; Hormone therapy

Outcome Measures

Primary Outcomes (1)

• Menopausal symptoms

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

  12 weeks

Secondary Outcomes (3)

• sexual function

  12 weeks

• lower urinary tract symptoms

  12 weeks

• psychosomatic symptoms

  12 weeks

Study Arms (2)

Tibolone group

EXPERIMENTAL

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

Conventional hormone therapy group

ACTIVE COMPARATOR

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

Interventions

Tibolone DRUG

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

Tibolone group

Estradiol & medroxyprogesterone acetate DRUG

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

Conventional hormone therapy group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients with gynecologic or breast cancers

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 220, Taiwan

Location

Related Publications (1)

• Hsiao SM, Liao SC. Effect of tibolone vs hormone replacement therapy on climacteric symptoms and psychological distress. J Chin Med Assoc. 2024 Feb 1;87(2):189-195. doi: 10.1097/JCMA.0000000000001012. Epub 2023 Oct 26.

  PMID: 37882059 DERIVED

MeSH Terms

Interventions

tibolone; Lunelle

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: April 2, 2013
• Study Start: November 16, 2012
• Primary Completion: July 8, 2021
• Study Completion: August 26, 2021
• Last Updated: February 23, 2022

Record last verified: 2021-12

Locations

TW (1)