HRT on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness

Last updated: June 13, 2024
Sponsor: Far Eastern Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hot Flash

Depression

Female Hormonal Deficiencies/abnormalities

Treatment

Tibolone 2.5 mg

Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg

Clinical Study ID

NCT05280028
110262-F
  • Ages > 20
  • Female

Study Summary

Therefore, the aim of this study is to assess the therapeutic effect on overactive bladder symptoms, sexual function, heart rate variability, arterial stiffness, atherosclerosis, sleep, and depression between tibolone and E2V/MPA.

From the results, the investigators will compare the effect of tibolone versus E2V/MPA on overactive bladder symptoms, sexual function, autonomic function, arterial stiffness, atherosclerosis, sleep and depression.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • >20 years old female

  • Menopausal symptoms, still have a uterus, and no breast or other cancers, and novascular-blocking disease such as stroke.

Exclusion

Exclusion Criteria:

  • Nil.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Tibolone 2.5 mg
Phase:
Study Start date:
February 07, 2022
Estimated Completion Date:
December 31, 2026

Study Description

Menopausal syndromes include overactive bladder symptom, autonomic symptoms, and even sexual dysfunction. 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), and conjugated equine estrogens (CEE) & MPA.

However, only a few literatures mentioned about the therapeutic effect of tibolone, but lack of comparison research about their therapeutic effect on overactive bladder symptoms, sexual function, heart rate variability, arterial stiffness, atherosclerosis, sleep and depression. 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 overactive bladder symptoms, sexual function, heart rate variability and arterial stiffness between tibolone and E2V/MPA.

All female patients with intact uterus who underwent treatment for menopausal syndrome at Far Eastern Memorial Hospital from October 2021 will be included. An open-labeled, prospective, comparative study design will be used. HT included tibolone (2.5 mg/day) or E2V (1mg) & MPA (2.5 mg) per day. The enrolled women will be requested to complete the Greene climacteric scale, Urgency Severity Scale, Overactive Bladder Symptom Score, the International Prostate Symptom Score (IPSS), the Female Sexual Function Index (FSFI), the Pittsburgh Sleep Quality Index, Center for Epidemiological Studies Depression questionnaire, heart rate variability, arterial stiffness and atherosclerosis examinations at baseline, and 4 weeks (visit 2) and 12 weeks (visit 3) after treatment.

From the results, the investigators will compare the effect of tibolone versus E2V/MPA on overactive bladder symptoms, sexual function, autonomic function, arterial stiffness, atherosclerosis, sleep and depression. Currently, there is no similar research as our current study.

Connect with a study center

  • Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

    Banqiao, New Taipei 22050
    Taiwan

    Active - Recruiting

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