NCT03436303

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

The Effect and Risk of Conjugated Estrogens Combined With Different Types of Progestin in the Treatment of Menopause Syndrome During Window Phase

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
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
DRUG	CEE 0.625mg/dydrogesterone	CEE 0.3 mg/dydrogesterone 10mg daily for the last 12 days of every 28 days for two years

Timeline

• Start date: 2014-02-01
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2018-02-19
• Last updated: 2018-02-19

Locations

1 site across 1 country: China