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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Menopause Syndrome

Treatments: Drug: CEE 0.625 mg/MP 100mg; Drug: CEE 0.625mg/dydrogesterone; Drug: CEE 0.3 mg/MP 100mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03436303

HRT14021808

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

CEE 0.625 mg/MP 100mg

Experimental group

Description:

CEE 0.625 mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years

Treatment:

Drug: CEE 0.625 mg/MP 100mg

CEE 0.3 mg/MP 100mg

Experimental group

Description:

CEE 0.3mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years

Treatment:

Drug: CEE 0.3 mg/MP 100mg

CEE 0.625 mg/dydrogesterone 10mg

Experimental group

Description:

CEE 0.625 mg/dydrogesterone 10 mg daily for the last 12 days of every 28 days for two years

Treatment:

Drug: CEE 0.625mg/dydrogesterone