Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
Banqiao District, New Taipei, 22050, Taiwan
Location status: Recruiting
NCT Number: NCT05280028
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.
Interested in participating?
Request Info20 year and older
Female
Observational
Banqiao District, New Taipei, 22050, Taiwan
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tibolone 2.5 mg per day
Other names: Livial
Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg per day
Other names: Indivina
Time frame: 3 months
Compare the effect of tibolone versus E2V/MPA on the total score of Overactive Bladder symptoms Score Total scores:0-15, the minimum values and whether lowest scores mean a better outcome
Time frame: 3 months
Compare the effect of tibolone versus E2V/MPA on total score of the Female Sexual Function Index Total scores:4-95, the maximum values and whether higher scores mean a better outcome.
Time frame: 3 months
Compare the effect of tibolone versus E2V/MPA on heart rate variability parameters
Time frame: 3 months
Compare the effect of tibolone versus E2V/MPA on cardio-ankle vascular index
Time frame: 3 months
Compare the effect of tibolone versus E2V/MPA on ankle-brachial pressure index
Contact information is provided by the study sponsor or research team.
Far Eastern Memorial Hospital
Other
The Impact of Different Hormone Therapy Regimens on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness
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