NCT05982470

Effect of Menopause Hormone Therapy In Postmenopausal Women With CSVD And MCI

Effect of Menopause Hormone Therapy In Postmenopausal Women With CeRebral Small Vessel DiseAse And Mild Cognitive DecLinE

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical trial is to explore the efficacy of menopausal hormone therapy in early menopausal women with CSVD and MCI. The main questions it aims to answer are: * The efficacy of menopausal hormone mainly estrogen therapy for early menopausal women with CSVD and MCI * The role of MHT in delaying the progression of cognitive function, CSVD imaging features, and other clinical symptoms and the potential pathophysiological mechanisms. Participants will be divided randomly into two groups taking MHT drugs and placebo respectively and followed up for 12 months to collect relevant clinical data.

Detailed description

Cerebral small vessel disease (CSVD) is a common chronic whole brain syndrome in middle-aged and elderly people, mainly involving small-arteries, arterioles, capillaries, venules and small-veins in the brain. CSVD mainly relies on typical imaging features for diagnosis. Aging is the most common risk factor for CSVD. With the acceleration of China's aging process, the Disease burden of CSVD is increasing. Menopause refers to the permanent cessation of menstruation caused by ovarian failure. During menopause, drastic changes in hormones can have a series of effects on women.Research shows that menopause is an independent risk factor for WMH. Meanwhile, menopause is significantly associated with cognitive impairment, especially with decreased learning, memory, and attention. Menopause can also cause changes in cerebral hemodynamics, damage to the integrity of the Blood-brain barrier and atrophy of cortical structures. Estrogen not only plays a crucial role in maintaining vascular function, but also has significant neuro-protective effects. Estrogen-based menopausal hormone therapy (MHT) is essentially a treatment measure taken to compensate for ovarian failure caused by aging. However, it is still unclear whether MHT can effectively alleviate CSVD symptoms and delay CSVD progression. The MHT treatment plan may also be an important reason for the inconsistent conclusions on the impact of MHT on cognitive function in various clinical studies. In previous clinical studies, the MHT regimen was oral estrogen (with or without Progestogen). Based on the above research background, MHT, especially the MHT regimen using transdermal estrogen, may be an effective treatment method to improve and alleviate the rapid progression of CSVD in perimenopausal women(without contraindications). So far, there have been no RCT studies evaluating the effectiveness and safety of MHT in CSVD patients internationally. Therefore, more research is needed to provide stronger evidence and provide new directions and basis for the treatment of CSVD. Participates who met the inclusion criteria were randomly divided into two groups. Participants were treated with MHT/placebo followed up for 12 months, and collected and analyzed relevant clinical data to evaluate the efficacy.

Conditions

• Cerebral Small Vessel Diseases
• Postmenopausal Symptoms
• Mild Cognitive Impairment
• White Matter Hyperintensity

Interventions

Type	Name	Description
DRUG	Estradiol Gel	Estradiol gel 2.5 g (containing 17β estradiol 1.5mg) once daily (percutaneous application) for 12 months
DRUG	Estradiol Placebo Gel	Estradiol placebo gel 2.5 g (containing 17β estradiol 1.5mg) once daily (percutaneous application) for 12 months
DRUG	Progesterone Soft Capsule	Progesterone soft capsules 100mg once daily (oral) for 12 months
DRUG	Progesterone Placebo Soft Capsule	Progesterone placebo soft capsules 100mg once daily (oral) for 12 months

Timeline

• Start date: 2023-08-18
• Primary completion: 2025-06-01
• Completion: 2025-10-01
• First posted: 2023-08-08
• Last updated: 2023-08-08

Locations

1 site across 1 country: China