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

NCT03436303 | Unknown Phase 4 DMC

• 1 other identifier: HRT14021808
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 .

Conditions

Menopause Syndrome

Keywords

Menopause Syndrome; low dose estrogen; progestin

Outcome Measures

Primary Outcomes (3)

• LDL-cholesterol

  5 minutes

• body fat mass percentage

  DEXA method

  5 minutes

• breast mammography

  5 minutes

Secondary Outcomes (9)

• glucose

  5 minutes

• bone mineral density

  5 minutes

• Mini-mental State Examination score

  5 minutes

• HAD scale

  5 minutes

• modified Kupperman score

  5 minutes

Study Arms (3)

CEE 0.625 mg/MP 100mg

EXPERIMENTAL

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 0.3 mg/MP 100mg

EXPERIMENTAL

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 0.625 mg/dydrogesterone 10mg

EXPERIMENTAL

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

Interventions

CEE 0.625 mg/MP 100mg DRUG

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

CEE 0.625 mg/MP 100mg

CEE 0.3 mg/MP 100mg DRUG

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

CEE 0.3 mg/MP 100mg

CEE 0.625mg/dydrogesterone DRUG

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

CEE 0.625 mg/dydrogesterone 10mg

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• and 60 years old;
• natural amenorrhea for more than 6 months but less than 5 years;
• suffered by menopause symptoms and seeking for treatment;
• serum follicle-stimulating hormone levels \>40 IU/L and serum estradiol \<30 pg/ml.

You may not qualify if:

• contraindications for menopausal hormone therapy;
• 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;
• 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;
• alcohol or drug abuse within the last 3 months;
• use of hormone therapy in the past 3months;
• endometrial thickness more than 5mm even after progestin withdrawal;
• abnormal cervical scraping smear;
• allergic to any ingredient of the drugs;
• participation in other clinical trials within the last 6 months.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Lei Li

Beijing, China/Beiing, 100000, China

Location

Related Publications (2)

• 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.

  PMID: 17689624 BACKGROUND

• 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.

  PMID: 15252707 BACKGROUND

MeSH Terms

Interventions

2-chloroethyl ethyl sulfide; Dydrogesterone

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Aijun Sun, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 19, 2018
• Study Start: February 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, 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.

Locations

CN (1)