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

• ClinicalTrials.gov Identifier: NCT03436303
• Recruitment Status: Unknown
• First Posted: February 19, 2018
• Last Update Posted: February 19, 2018
• Sponsor: Peking Union Medical College Hospital
• Information provided by (Responsible Party): Aijun Sun, Peking Union Medical College Hospital

Study Description

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 .

Condition or disease	Intervention/treatment	Phase
Menopause Syndrome	Drug: CEE 0.625 mg/MP 100mg; Drug: CEE 0.3 mg/MP 100mg; Drug: CEE 0.625mg/dydrogesterone	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: The Effect and Risk of Conjugated Estrogens Combined With Different Types of Progestin in the Treatment of Menopause Syndrome During Window Phase
• Actual Study Start Date: February 1, 2014
• Estimated Primary Completion Date: June 1, 2018
• Estimated Study Completion Date: December 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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
Experimental: 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	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
Experimental: 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	Drug: CEE 0.625mg/dydrogesterone; CEE 0.3 mg/dydrogesterone 10mg daily for the last 12 days of every 28 days for two years

Outcome Measures

Primary Outcome Measures :

1. LDL-cholesterol [ Time Frame: 5 minutes ]
2. body fat mass percentage [ Time Frame: 5 minutes ]
   DEXA method
3. breast mammography [ Time Frame: 5 minutes ]

Secondary Outcome Measures :

1. glucose [ Time Frame: 5 minutes ]
2. bone mineral density [ Time Frame: 5 minutes ]
3. Mini-mental State Examination score [ Time Frame: 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.
4. HAD scale [ Time Frame: 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.
5. modified Kupperman score [ Time Frame: 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
6. Endometrial thickness [ Time Frame: 5 minutes ]
   ultrasound
7. weight [ Time Frame: 5 minutes ]
8. serum creatinine [ Time Frame: 5 minutes ]
9. serum glutamic pyretic transaminase [ Time Frame: 5 minutes ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

China, China/Beiing

Lei Li

Beijing, China/Beiing, China, 100000

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

• Principal Investigator: Aijun Sun, MD; Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences

More Information

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.

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.

• Responsible Party: Aijun Sun, professor, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT03436303
• Other Study ID Numbers: HRT14021808
• First Posted: February 19, 2018
• Last Update Posted: February 19, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Network platform, and the website will be attached later.
• Supporting Materials: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: Within 2 months after the trial complete
• Access Criteria: Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aijun Sun, Peking Union Medical College Hospital:

Menopause Syndrome; low dose estrogen; progestin

Additional relevant MeSH terms:

Syndrome; Disease; Pathologic Processes; Dydrogesterone; Progestins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs