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

NCT ID: NCT03436303

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-01
• Study Completion Date: 2018-12-01

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.

Conditions

Menopause Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CEE 0.625 mg/MP 100mg

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

CEE 0.3 mg/MP 100mg

Intervention Type: DRUG

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

CEE 0.625 mg/dydrogesterone 10mg

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

Group Type: EXPERIMENTAL

CEE 0.625mg/dydrogesterone

Intervention Type: DRUG

CEE 0.3 mg/dydrogesterone 10mg daily for the last 12 days of every 28 days for two years

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

CEE 0.625mg/dydrogesterone

CEE 0.3 mg/dydrogesterone 10mg daily for the last 12 days of every 28 days for two years

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aijun Sun

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aijun Sun, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Lei Li

Beijing, China/Beiing, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 17689624 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15252707 (View on PubMed)

Other Identifiers

HRT14021808

Identifier Type: -

Identifier Source: org_study_id