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

NCT05280028 | Recruiting

• 1 other identifier: 110262-F
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopausal Syndrome

Outcome Measures

Primary Outcomes (4)

• 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

  3 months

• 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.

  3 months

• Autonomic function

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

  3 months

• Arterial stiffness

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

  3 months

Secondary Outcomes (1)

• Atherosclerosis

  3 months

Study Arms (2)

Tibolone

Tibolone 2.5 mg per day

Drug: Tibolone 2.5 mg

Indivina

Estradiol valerate (E2V) 1mg \& medroxyprogesterone acetate 2.5 mg (MPA) per day

Drug: Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg

Interventions

Tibolone 2.5 mg DRUG

Tibolone 2.5 mg per day

Also known as: Livial

Tibolone

Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg DRUG

Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg per day

Also known as: Indivina

Indivina

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with menopausal symptoms

You may qualify if:

• \>20 years old female
• Menopausal symptoms, still have a uterus, and no breast or other cancers, and no vascular-blocking disease such as stroke.

You may not qualify if:

• Nil.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

RECRUITING

MeSH Terms

Interventions

tibolone; Estradiol; Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes

Study Officials

• Sheng-Mou Hsiao, MD

  Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng-Mou Hsiao, MD

CONTACT

+8868966700; smhsiao2@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 15, 2022
• Study Start: February 7, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

TW (1)