Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tibolone | Drug | Tibolone 2.5 mg once a day for patients with menopausal syndrome (self-paid) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Menopausal symptoms | To clarify any difference of reduction in menopausal symptom scores between these two groups | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| sexual function | To clarify any difference of improvements of sexual function scores between these two groups | 12 weeks |
| lower urinary tract symptoms | To clarify any difference of improvements of lower urinary tract symptoms scores between these two groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Far Eastern Memorial Hospital | Banqiao District | New Taipei | 220 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37882059 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C027385 | tibolone |
| C403500 | Lunelle |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Estradiol & medroxyprogesterone acetate | Drug | Estradiol & medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug |
|
| 12 weeks |
| psychosomatic symptoms | To clarify any difference of improvements of psychosomatic symptoms scores between these two groups | 12 weeks |