Menopausal SyndromePhase 4NCT01698164
Multi-centre Clinical Trial on Hormone Replacement Treatment in China
A Phase 4 study testing estradiol plus MPA, Ximingting Tablet and estradiol plus progesterone in people with Menopausal Syndrome and Cardiovascular Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is to evaluate the benefit/risk of hormone replacement treatment among early menopausal women in China. This is a multi-centre, random, prospective study. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Menopausal Syndrome, Cardiovascular Disease, Osteoporosis
- What is being tested?
- estradiol plus MPA, Ximingting Tablet and estradiol plus progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to Oct 2012
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- going through amenorrhea above 6 months and within 5 years,
- aged 40 to 60 years,
- going though postmenopausal symptoms,
- serum E2 concentration <30pg/ml,
- serum FSH concentration >40IU/L.
Who cannot join
- uterine fibroid diameter≥5cm,
- history of diabetes or hypertension,
- history of thromboembolism, severe endometriosis, epilepsy, asthma, hyperprolactinemia,
- first degree relative had a history of breast cancer,
- being in severe or unstable condition of somatic diseases,
- receiving HRT in the past 3 month,
Show all 10Show fewer
- drug or alcohol abuse in the past 3 month,
- endometrial thickness ≥0.5cm after withdrawal bleeding,
- being allergic to the medicine,
- participating in other clinical trials within 1 month ago.
Trial locations and contacts
1 site in 1 country.
Tingping Zheng, Bachelor Degree contact
China1 site, 1 recruiting
- Recruiting
PUMCH
Beijing, Beijing Municipality, 100730
Wei Xue, Bachelor Degree, xuewei8955@sina.com
About this study
This study is to evaluate the benefit/risk of hormone replacement treatment among early menopausal women in China. This is a multi-centre, random, prospective study.
- Being tested
- estradiol plus MPA, Ximingting Tablet, estradiol plus progesterone
- Keywords
- lipid profiles, coronary heart disease, menopausal syndrome, MMSE, MENQOL, HAD
- Medical subject headings
- Cardiovascular Diseases, Osteoporosis, Breast Neoplasms, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiol plus MPADrug
Participants are given estradiol and synthetic progestin.
Ximingting TabletDrug
Participants are given phytoestrogen.
estradiol plus progesteroneDrug
Participants are given estradiol and natural progesterone.
| Study group | Role | What they receive |
|---|---|---|
| estradiol plus MPA | Active comparator | 1 mg estradiol valerate, once a day, for 28 days, since the 17th day of taking estradiol valerate adding 4mg medroxyprogesterone acetate, once a day, for 12 days. 28 days forms one cycle. The anticipated duration is 24cycles.
estradiol valerate, 1mg*21/box medroxyprogesterone acetate, 2mg*100/bottle Receives: Drug: estradiol plus MPA |
| estradiol plus progesterone | Experimental | 1 mg estradiol valerate, once a day, for 28 days, since the 17th day of taking estradiol valerate adding 200mg progesterone capsule, once a day, for 12 days. 28 days forms one cycle. The anticipated duration is 24cycles.
estradiol valerate, 1mg*21/box progesterone capsule, 100mg*6/box Receives: Drug: estradiol plus progesterone |
| Ximingting tablet | Experimental | 1 tablet of cimicifuga rhizoma extract, tid 100mg*15*2/box The anticipated duration is 2 years. Receives: Drug: Ximingting Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months
lipid profiles, high-sensitivity C-reactive protein, Hemoglobin A1C, fasting glucose, fasting insulin, blood pressure, waistline, hipline, body composition, electrocardiogram, incidence of coronary heart disease
Measured: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicine for 2 years
Change from Baseline in risk factors of breast cancer at 12 months and 24 months
Mammography, palpation of breast, incidence of breast cancer
Measured: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years
Secondary outcomes (3)
Change from Baseline in BMD at 12 months and 24 months
DEXA bone mineral density
Measured: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years
Change from Baseline in risk factors of senile dementia every three months
mini-mental state examination, hospital anxiety and depression scale
Measured: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later
Change from Baseline in the quality of life every three months
Kupperman menopause index, RAND36 Menopause-Specific quality of life questionaire
Measured: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startDec 2008
- Primary completionOct 2012 (estimated)
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 SyndromeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Aijun Sun, PH.D M.D, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698164
- Sponsor's protocol ID
- 2008BAI57B04
- Status last verified
- Sep 2012
- First submitted
- 25 Sep 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
Publications
Xue W, Deng Y, Wang YF, Sun AJ. Effect of Half-dose and Standard-dose Conjugated Equine Estrogens Combined with Natural Progesterone or Dydrogesterone on Components of Metabolic Syndrome in Healthy Postmenopausal Women: A Randomized Controlled Trial. Chin Med J (Engl). 2016 Dec 5;129(23):2773-2779. doi: 10.4103/0366-6999.194646.
PubMed 27900987
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre Clinical Trial on Hormone Replacement Treatment in China
- ClinicalTrials.gov ID
- NCT01698164
- Acronym / sponsor ID
- 2008BAI57B04
- Keywords
- lipid profiles, coronary heart disease, menopausal syndrome, MMSE, MENQOL, HAD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Oct 2012 (estimated)
- First posted
- 2 Oct 2012 (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.
This study is to evaluate the benefit/risk of hormone replacement treatment among early menopausal women in China. This is a multi-centre, random, prospective study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| estradiol plus MPA | Active comparator | Drug: estradiol plus MPA1 mg estradiol valerate, once a day, for 28 days, since the 17th day of taking estradiol valerate adding 4mg medroxyprogesterone acetate, once a day, for 12 days. 28 days forms one cycle. The anticipated duration is 24cycles. estradiol valerate, 1mg*21/box medroxyprogesterone acetate, 2mg*100/bottle |
| estradiol plus progesterone | Experimental | Drug: estradiol plus progesterone1 mg estradiol valerate, once a day, for 28 days, since the 17th day of taking estradiol valerate adding 200mg progesterone capsule, once a day, for 12 days. 28 days forms one cycle. The anticipated duration is 24cycles. estradiol valerate, 1mg*21/box progesterone capsule, 100mg*6/box |
| Ximingting tablet | Experimental | Drug: Ximingting Tablet1 tablet of cimicifuga rhizoma extract, tid 100mg*15*2/box The anticipated duration is 2 years. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- going through amenorrhea above 6 months and within 5 years,
- aged 40 to 60 years,
- going though postmenopausal symptoms,
- serum E2 concentration <30pg/ml,
- serum FSH concentration >40IU/L.
Key exclusion criteria (10 listed)
- uterine fibroid diameter≥5cm,
- history of diabetes or hypertension,
- history of thromboembolism, severe endometriosis, epilepsy, asthma, hyperprolactinemia,
- first degree relative had a history of breast cancer,
- being in severe or unstable condition of somatic diseases,
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 |
|---|---|---|
| estradiol plus MPAParticipants are given estradiol and synthetic progestin. | Drug | estradiol plus MPA |
| Ximingting TabletParticipants are given phytoestrogen. | Drug | Ximingting tablet |
| estradiol plus progesteroneParticipants are given estradiol and natural progesterone. | Drug | estradiol plus progesterone |
Primary outcome
Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months
Time frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicine for 2 years
lipid profiles, high-sensitivity C-reactive protein, Hemoglobin A1C, fasting glucose, fasting insulin, blood pressure, waistline, hipline, body composition, electrocardiogram, incidence of coronary heart disease
Change from Baseline in risk factors of breast cancer at 12 months and 24 months
Time frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years
Mammography, palpation of breast, incidence of breast cancer
3 secondary outcomes
Change from Baseline in BMD at 12 months and 24 months
Time frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicien for 2 years
Change from Baseline in risk factors of senile dementia every three months
Time frame: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later
Change from Baseline in the quality of life every three months
Time frame: before the recruitment, before handing out the mecidcine, every three months after taking the medicine till two years later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- Derived from this study: PubMed 27900987Xue W, Deng Y, Wang YF, Sun AJ. Effect of Half-dose and Standard-dose Conjugated Equine Estrogens Combined with Natural Progesterone or Dydrogesterone on Components of Metabolic Syndrome in Healthy Postmenopausal Women: A Randomized Controlled Trial. Chin Med J (Engl). 2016 Dec 5;129(23):2773-2779. doi: 10.4103/0366-6999.194646.
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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.
Tingping Zheng, Bachelor Degree contact
Aijun Sun, PH.D M.D study director
Peking Union Medical College Hospital
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 estradiol plus MPA, Ximingting Tablet and estradiol plus progesterone in people with Menopausal Syndrome and Cardiovascular Disease, run by Peking Union Medical College Hospital at 1 site in China.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Oct 2012. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tingping Zheng, Bachelor Degree (zhengtingping@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in risk factors of cardiovascular disease at 12 months and 24 months (time frame: before the treatment, time point of taking the medicine for 1 year, time point of taking the medicine for 2 years). The study lists 2 primary outcomes in all. 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 NCT01698164, 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 2 Oct 2012.