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

NCT05982470 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2023-08-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • yilong wang, MD,PhD · Beiiing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-18
Primary Completion
2025-06-01
Completion
2025-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05982470 on ClinicalTrials.gov