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

Phase 4

• Conditions: Menopause Syndrome
• Interventions: Drug: CEE 0.625 mg/MP 100mg; Drug: CEE 0.3 mg/MP 100mg; Drug: CEE 0.625mg/dydrogesterone

• Registration Number: NCT03436303
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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 .

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.

Study Timeline

• Study Start: 2014-02-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-10
• Last Update Submitted: 2018-02-10
• Study First Posted: 2018-02-19
• Last Update Posted: 2018-02-19
• Primary Completion: 2018-06-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
LDL-cholesterol	5 minutes
body fat mass percentage	5 minutes	DEXA method
breast mammography	5 minutes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, China/Beiing, China