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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20+
SponsorFar Eastern Memorial Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

>20 years old female

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

Disqualifiers

Nil.

Trial population

Women with menopausal symptoms

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Tibolone 2.5 mg

    Drug

    Tibolone 2.5 mg per day

  • Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg

    Drug

    Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg per day

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Tibolone1 intervention
Group B: Indivina1 intervention

Trial outcomes

Primary outcomes

1

Overactive bladder symptoms

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
2

Sexual function index

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
3

Autonomic function

Compare the effect of tibolone versus E2V/MPA on heart rate variability parameters

Time frame
3 months
4

Arterial stiffness

Compare the effect of tibolone versus E2V/MPA on cardio-ankle vascular index

Time frame
3 months

Secondary outcomes

1

Atherosclerosis

Compare the effect of tibolone versus E2V/MPA on ankle-brachial pressure index

Time frame
3 months

Other outcomes

Sponsors and contacts

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