Menopause SyndromePhase 4NCT03436303

The Benefits and Risks of Different Menopausal Hormone Replacement Therapy Regimes in the Treatment of Menopause Syndrome

A Phase 4 study testing CEE 0.625 mg/MP 100mg, CEE 0.3 mg/MP 100mg and CEE 0.625mg/dydrogesterone in people with Menopause Syndrome, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

A prospective, open-label, randomized controlled clinical trial to compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(CEE) plus natural progesterone or dydrogesterone in menopausal hormone therapy . Read more about this study

Who is it for?: Ages 40 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Menopause Syndrome
What is being tested?: CEE 0.625 mg/MP 100mg, CEE 0.3 mg/MP 100mg and CEE 0.625mg/dydrogesterone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: 1 Feb 2014to 1 Dec 2018
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
Healthy volunteers accepted
Adult

Who may be able to join

40 and 60 years old;
natural amenorrhea for more than 6 months but less than 5 years;
suffered by menopause symptoms and seeking for treatment;
serum follicle-stimulating hormone levels >40 IU/L and serum estradiol <30 pg/ml.

Who cannot join

contraindications for menopausal hormone therapy;
complications including: uterine myoma more than 3 centimeter in diameter, endometriosis, uncontrolled hypertension or diabetes mellitus, thromboembolic disease history or high risk for developing thromboembolic disease, epilepsy, asthma, hyperprolactinemia, first degree relative has breast cancer;
cardiovascular, chronic liver, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol;
alcohol or drug abuse within the last 3 months;
use of hormone therapy in the past 3months;
endometrial thickness more than 5mm even after progestin withdrawal;

Show all 9Show fewer

abnormal cervical scraping smear;
allergic to any ingredient of the drugs;
participation in other clinical trials within the last 6 months.

Trial locations and contacts

1 site in 1 country.

China1 site

Lei Li
Beijing, China/Beiing, 100000

Other trials in China

About this study

Official title: The Effect and Risk of Conjugated Estrogens Combined With Different Types of Progestin in the Treatment of Menopause Syndrome During Window Phase

Read the detailed description

This is a prospective, open-label, randomized controlled clinical trial compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(CEE) plus natural progesterone or dydrogesterone in menopausal hormone therapy during window phase. 120 Healthy postmenopausal women with intact uterus seeking treatment for menopausal symptoms are enrolled in this study.Participants are randomized into three groups, the CEE 0.3 mg/micronized progesterone (MP) 100 mg group; CEE 0.625 mg/MP 100 mg group; CEE 0.625 mg/dydrogesterone 10 mg group,metabolic parameters,body composition,bone mineral density,breast cancer risk factors and life quality will be measure at baseline,one year and two year intervention.The investigators hypothesize there may be differences of these parameters measured among three groups after intervention.

Conditions: Menopause Syndrome
Being tested: CEE 0.625 mg/MP 100mg, CEE 0.3 mg/MP 100mg, CEE 0.625mg/dydrogesterone
Keywords: Menopause Syndrome, low dose estrogen, progestin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CEE 0.625 mg/MP 100mgDrug
CEE 0.625 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years
CEE 0.3 mg/MP 100mgDrug
CEE 0.3 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years
CEE 0.625mg/dydrogesteroneDrug
CEE 0.3 mg/dydrogesterone 10mg daily for the last 12 days of every 28 days for two years

Study groups in NCT03436303
Study group	Role	What they receive
CEE 0.625 mg/MP 100mg	Experimental	CEE 0.625 mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years Receives: Drug: CEE 0.625 mg/MP 100mg
CEE 0.3 mg/MP 100mg	Experimental	CEE 0.3mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years Receives: Drug: CEE 0.3 mg/MP 100mg
CEE 0.625 mg/dydrogesterone 10mg	Experimental	CEE 0.625 mg/dydrogesterone 10 mg daily for the last 12 days of every 28 days for two years Receives: Drug: CEE 0.625mg/dydrogesterone

What is being measured

The primary outcome is the main question the study is designed to answer.

LDL-cholesterol
Measured: 5 minutes
body fat mass percentage
DEXA method
Measured: 5 minutes
breast mammography
Measured: 5 minutes

Secondary outcomes (9)

glucose
Measured: 5 minutes
bone mineral density
Measured: 5 minutes
Mini-mental State Examination score
Questionnaire.The score range is 0-30.Total score greater than or equal to 24 points indicates a normal cognition,below this, scores can indicate cognitive impairment.
Measured: 5 minutes
HAD scale
questionnaire to evaluate anxiety and depression.The total score is 0-20.Total score 0-7 is normal,8-10 maybe borderline anxiety or depression,11-20 indicates obvious anxiety or depression.
Measured: 5 minutes
modified Kupperman score
questionnaire to evaluate the menopause symptom.The total score range is 0-63.Total score below 6 is normal,6-15 is mild,16-30 is moderate, above 30 is severe
Measured: 5 minutes
Endometrial thickness
ultrasound
Measured: 5 minutes
weight
Measured: 5 minutes
serum creatinine
Measured: 5 minutes
serum glutamic pyretic transaminase
Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20141 Dec 2018

First posted19 Feb 2018
Study start1 Feb 2014
Primary completion1 Jun 2018 (estimated)
Study completion1 Dec 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Menopause 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
Model description: randomly assigned to three groups: CEE 0.3 mg/micronized progesterone (MP) 100 mg group, CEE 0.625 mg/MP 100 mg group,CEE 0.625 mg/dydrogesterone 10 mg group.
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03436303
Sponsor's protocol ID: HRT14021808
Status last verified: Feb 2018
First submitted: 2 Feb 2018
Last updated: 19 Feb 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Network platform, and the website will be attached later.

Publications

Thorneycroft IH, Lindsay R, Pickar JH. Body composition during treatment with conjugated estrogens with and without medroxyprogesterone acetate: analysis of the women's Health, Osteoporosis, Progestin, Estrogen (HOPE) trial. Am J Obstet Gynecol. 2007 Aug;197(2):137.e1-7. doi: 10.1016/j.ajog.2007.05.042.
PubMed 17689624
Margolis KL, Bonds DE, Rodabough RJ, Tinker L, Phillips LS, Allen C, Bassford T, Burke G, Torrens J, Howard BV; Women's Health Initiative Investigators. Effect of oestrogen plus progestin on the incidence of diabetes in postmenopausal women: results from the Women's Health Initiative Hormone Trial. Diabetologia. 2004 Jul;47(7):1175-1187. doi: 10.1007/s00125-004-1448-x. Epub 2004 Jul 14.
PubMed 15252707

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
Serum Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 After Resveratrol Supplementation
Coronary Artery Disease (CAD), Menopause
Recruiting
Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women
Menopause, Menopause Hot Flashes
Recruiting
Exercise as Medicine: A Non-Pharmacological Approach to Menopausal Symptoms
Menopause Syndrome, Sleep Disturbance
Active, not recruiting
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
Cardiovascular Diseases

All Menopause Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect and Risk of Conjugated Estrogens Combined With Different Types of Progestin in the Treatment of Menopause Syndrome During Window Phase
ClinicalTrials.gov ID: NCT03436303
Acronym / sponsor ID: HRT14021808
Conditions: Menopause Syndrome
Keywords: Menopause Syndrome, low dose estrogen, progestin
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: Peking Union Medical College HospitalUniversity, hospital or other
Study start: 1 Feb 2014 (actual)
Primary completion: 1 Jun 2018 (estimated)
Study completion: 1 Dec 2018 (estimated)
First posted: 19 Feb 2018 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: randomly assigned to three groups: CEE 0.3 mg/micronized progesterone (MP) 100 mg group, CEE 0.625 mg/MP 100 mg group,CEE 0.625 mg/dydrogesterone 10 mg group.

Arm	Type	Receives
CEE 0.625 mg/MP 100mg	Experimental	Drug: CEE 0.625 mg/MP 100mgCEE 0.625 mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years
CEE 0.3 mg/MP 100mg	Experimental	Drug: CEE 0.3 mg/MP 100mgCEE 0.3mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years
CEE 0.625 mg/dydrogesterone 10mg	Experimental	Drug: CEE 0.625mg/dydrogesteroneCEE 0.625 mg/dydrogesterone 10 mg daily for the last 12 days of every 28 days for two years

Who may qualify

Ages: 40 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

40 and 60 years old;
natural amenorrhea for more than 6 months but less than 5 years;
suffered by menopause symptoms and seeking for treatment;
serum follicle-stimulating hormone levels >40 IU/L and serum estradiol <30 pg/ml.

Key exclusion criteria (9 listed)

contraindications for menopausal hormone therapy;
complications including: uterine myoma more than 3 centimeter in diameter, endometriosis, uncontrolled hypertension or diabetes mellitus, thromboembolic disease history or high risk for developing thromboembolic disease, epilepsy, asthma, hyperprolactinemia, first degree relative has breast cancer;
cardiovascular, chronic liver, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol;
alcohol or drug abuse within the last 3 months;
use of hormone therapy in the past 3months;

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
CEE 0.625 mg/MP 100mgCEE 0.625 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years	Drug	CEE 0.625 mg/MP 100mg
CEE 0.3 mg/MP 100mgCEE 0.3 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years	Drug	CEE 0.3 mg/MP 100mg
CEE 0.625mg/dydrogesteroneCEE 0.3 mg/dydrogesterone 10mg daily for the last 12 days of every 28 days for two years	Drug	CEE 0.625 mg/dydrogesterone 10mg

Primary outcome

LDL-cholesterol
Time frame: 5 minutes
body fat mass percentage
Time frame: 5 minutes
DEXA method
breast mammography
Time frame: 5 minutes

9 secondary outcomes

glucose
Time frame: 5 minutes
bone mineral density
Time frame: 5 minutes
Mini-mental State Examination score
Time frame: 5 minutes
HAD scale
Time frame: 5 minutes
modified Kupperman score
Time frame: 5 minutes
Endometrial thickness
Time frame: 5 minutes
weight
Time frame: 5 minutes
serum creatinine
Time frame: 5 minutes
serum glutamic pyretic transaminase
Time frame: 5 minutes

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
Background: PubMed 17689624Thorneycroft IH, Lindsay R, Pickar JH. Body composition during treatment with conjugated estrogens with and without medroxyprogesterone acetate: analysis of the women's Health, Osteoporosis, Progestin, Estrogen (HOPE) trial. Am J Obstet Gynecol. 2007 Aug;197(2):137.e1-7. doi: 10.1016/j.ajog.2007.05.042.
Background: PubMed 15252707Margolis KL, Bonds DE, Rodabough RJ, Tinker L, Phillips LS, Allen C, Bassford T, Burke G, Torrens J, Howard BV; Women's Health Initiative Investigators. Effect of oestrogen plus progestin on the incidence of diabetes in postmenopausal women: results from the Women's Health Initiative Hormone Trial. Diabetologia. 2004 Jul;47(7):1175-1187. doi: 10.1007/s00125-004-1448-x. Epub 2004 Jul 14.
Individual participant dataSharing planned: Yes. Network platform, and the website will be attached later.

Related trials for Menopause Syndrome

Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
Serum Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 After Resveratrol Supplementation
Coronary Artery Disease (CAD), Menopause
Recruiting
Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women
Menopause, Menopause Hot Flashes
Recruiting
Exercise as Medicine: A Non-Pharmacological Approach to Menopausal Symptoms
Menopause Syndrome, Sleep Disturbance
Active, not recruiting
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
Cardiovascular Diseases

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.

Aijun Sun, MD principal investigator

Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences

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 CEE 0.625 mg/MP 100mg, CEE 0.3 mg/MP 100mg and CEE 0.625mg/dydrogesterone in people with Menopause Syndrome, 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 4 inclusion and 9 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 19 Feb 2018. 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?

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?

LDL-cholesterol (time frame: 5 minutes). The study lists 3 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 NCT03436303, which also lists 2 linked publications.

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 19 Feb 2018.