Menopausal SyndromesPhase 4NCT01822288
The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder
A Phase 4 study testing Tibolone and Estradiol & medroxyprogesterone acetate in people with Menopausal Syndromes, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Menopausal syndromes includes somatic symptom, psychosomatic symptoms, sexual dysfunction and even urinary symptoms. Hormone therapy (HT) is widely used for controlling menopausal symptoms. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Menopausal Syndromes
- What is being tested?
- Tibolone and Estradiol & medroxyprogesterone acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Nov 2012to 26 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All female patients with intact uterus who seek for medical treatment for menopausal syndrome
Who cannot join
- patients with gynecologic or breast cancers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Different Hormone Therapy Regimens on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder
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.
- Conditions
- Menopausal Syndromes
- Being tested
- Tibolone, Estradiol & medroxyprogesterone acetate
- Keywords
- Menopause, Tibolone, Estradiol, Hormone therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiboloneDrug
Tibolone 2.5 mg once a day for patients with menopausal syndrome (self-paid)
Estradiol & medroxyprogesterone acetateDrug
Estradiol \& medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tibolone |
| 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. Receives: Drug: Estradiol & medroxyprogesterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopausal symptoms
To clarify any difference of reduction in menopausal symptom scores between these two groups
Measured: 12 weeks
Secondary outcomes (3)
sexual function
To clarify any difference of improvements of sexual function scores between these two groups
Measured: 12 weeks
lower urinary tract symptoms
To clarify any difference of improvements of lower urinary tract symptoms scores between these two groups
Measured: 12 weeks
psychosomatic symptoms
To clarify any difference of improvements of psychosomatic symptoms scores between these two groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study start16 Nov 2012
- Primary completion8 Jul 2021
- Study completion26 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menopausal SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822288
- Sponsor's protocol ID
- 101080-F
- Status last verified
- Dec 2021
- First submitted
- 26 Nov 2012
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37882059
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Hormone Therapy Regimens on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder
- ClinicalTrials.gov ID
- NCT01822288
- Acronym / sponsor ID
- 101080-F
- Conditions
- Menopausal Syndromes
- Keywords
- Menopause, Tibolone, Estradiol, Hormone therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 16 Nov 2012 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tibolone group | Experimental | Drug: TiboloneTibolone (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 | Drug: Estradiol & medroxyprogesterone acetateEstradiol 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All female patients with intact uterus who seek for medical treatment for menopausal syndrome
Key exclusion criteria (1 listed)
- patients with gynecologic or breast cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TiboloneTibolone 2.5 mg once a day for patients with menopausal syndrome (self-paid) | Drug | Tibolone group |
| Estradiol & medroxyprogesterone acetateEstradiol \& medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug | Drug | Conventional hormone therapy group |
Primary outcome
Menopausal symptoms
Time frame: 12 weeks
To clarify any difference of reduction in menopausal symptom scores between these two groups
3 secondary outcomes
sexual function
Time frame: 12 weeks
lower urinary tract symptoms
Time frame: 12 weeks
psychosomatic symptoms
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Derived from this study: PubMed 37882059Hsiao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tibolone and Estradiol & medroxyprogesterone acetate in people with Menopausal Syndromes, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopausal symptoms (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01822288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.