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

Menopause Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03436303
• Other study ID #: HRT14021808
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 2, 2018
• Last updated: February 10, 2018
• Start date: February 1, 2014
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2018
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 .

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 40 and 60 years old;

2. natural amenorrhea for more than 6 months but less than 5 years;

3. suffered by menopause symptoms and seeking for treatment;

4. serum follicle-stimulating hormone levels >40 IU/L and serum estradiol <30 pg/ml.

Exclusion Criteria:

1. contraindications for menopausal hormone therapy;

2. 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;

3. 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;

4. alcohol or drug abuse within the last 3 months;

5. use of hormone therapy in the past 3months;

6. endometrial thickness more than 5mm even after progestin withdrawal;

7. abnormal cervical scraping smear;

8. allergic to any ingredient of the drugs;

9. participation in other clinical trials within the last 6 months.

Related Conditions & MeSH terms

• Menopause Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Lei Li	Beijing	China/Beiing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-cholesterol		5 minutes
Primary	body fat mass percentage	DEXA method	5 minutes
Primary	breast mammography		5 minutes
Secondary	glucose		5 minutes
Secondary	bone mineral density		5 minutes
Secondary	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.	5 minutes
Secondary	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.	5 minutes
Secondary	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	5 minutes
Secondary	Endometrial thickness	ultrasound	5 minutes
Secondary	weight		5 minutes
Secondary	serum creatinine		5 minutes
Secondary	serum glutamic pyretic transaminase		5 minutes