Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With MGD

September 9, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With Meibomian Gland Dysfunction

This project aims to evaluate the possible relationship between MGD and HRT in perimenopausal women

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This project aims to: 1. Evaluate the possible relationship between MGD and HRT in perimenopausal women; 2. To explore the mechanism of HRT treatment on MGD through clinical trials;3. Optimize treatment methods by exploring the mechanism, and develop more personalized and systematic treatment plans for MDG patients in the perimenopausal period.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Hangzhou, China
        • Recruiting
        • Second Affiliated Hospital of Zhejiang University Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 350051
        • Recruiting
        • Hangzhou Obstetrics and Gynecology Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

MGD is a relatively new field of research in ophthalmology, so it has not been extensively studied up to now. However, MGD is believed to be a major cause of DE disease worldwide. It is estimated that MGD accounts for more than two-thirds of all DE cases. In one study, MGD accounted for 78 % of DE patients. The estimated incidence of MGD in Asian adults over 40 years of age ranges from 46.2% to 69.3%. Previous studies have shown that the production and stability of tears in postmenopausal women are reduced, and hormone replacement therapy can restore SLT values to the normal range. However, some studies have reported that women who receive HRT have a higher mortality rate than women who do not.

Description

Inclusion Criteria:

  • Perimenopausal women who did not undergo HRT

Exclusion Criteria:

  • (1) Patients who meet any of the following criteria will not be eligible for inclusion in the study: ① Unable or unwilling to sign a consent form, or unable to follow study procedures.

    (2) Have worn contact lenses in the past month, have had anterior segment surgery in the past 3 months, have a history of corneal refractive surgery, and have eye diseases other than dry eyes.Use of topical medicines other than eye lubricants in the past 3 months.Use of total body immunomodulators, tetracycline, or glucocorticoids in the past 3 months.Occlusion of lacrimal dots or eye trauma in the past 3 months.③ is pregnant, nursing or breastfeeding, or has received HRT treatment.

    ④ All patients with DE related diseases, such as diabetes mellitus, Sjogren syndrome, Stevens-Johnson syndrome.All participants were free of cancer, liver disease, kidney disease, stroke, transient cerebral ischemia, myocardial infarction, peptic ulcer, gout, or mental illness.Women who used anticoagulants, corticosteroids or vitamin A, vitamin E or beta-carotene were also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Perimenopausal women who did not undergo HRT
Perimenopausal women who did not undergo HRT at baseline. And they did not receive any other drugs
Drug: Hormone replacement therapy
HRT women were treated with an estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV, Weesp, the Netherlands).Take this medicine once a day.A course of treatment was defined as 28 days of continuous treatment.One white tablet containing 1mg of estradiol was taken daily for the first 14 days and one gray tablet containing 1mg of estradiol and 10 mg of dynamic progesterone was taken daily for the remaining 14 days.
Other Names:
  • Received estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV, Weesp, The Netherlands)
Perimenopausal women who did undergo HRT
Perimenopausal women who did undergo HRT received estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV. Weesp, The Netherlands).Take this medicine once a day. A course of treatment was defined as 28 days of continuous treatment.
Drug: Hormone replacement therapy
HRT women were treated with an estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV, Weesp, the Netherlands).Take this medicine once a day.A course of treatment was defined as 28 days of continuous treatment.One white tablet containing 1mg of estradiol was taken daily for the first 14 days and one gray tablet containing 1mg of estradiol and 10 mg of dynamic progesterone was taken daily for the remaining 14 days.
Other Names:
  • Received estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV, Weesp, The Netherlands)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear secretion
Time Frame: 3 months
After local anesthesia, a 35mm×5mm filter paper strip was placed longitudinally into the conjunctival sac of the lower eyelid. After 5 minutes, the length of the moist part was recorded. Less than 10mm was considered abnormal.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Noninvasive tear break-up time test (NITBUT)
Time Frame: 3 months
After fluorescein staining, patients were asked to close their eyes and measure the time until the first tear film break point appeared.The average of the three measurements was recorded and was considered abnormal for less than 10 seconds.
3 months
The scoring of corneal fluorescein staining
Time Frame: 3 months
The cornea was divided into two groups on average. After staining, the upper, middle and lower corneal sites were recorded and the scores of each site were recorded.0= no punctate staining;1= less than half staining: 2= more than half staining;3= total staining;And the cumulative score (0-9 points) for each quadrant.CFS was assessed at each follow-up.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Director: Jin x ming, phd, Second Affiliated Hospital of Zhejiang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 6, 2019

Primary Completion (ANTICIPATED)

March 6, 2022

Study Completion (ANTICIPATED)

March 6, 2022

Study Registration Dates

First Submitted

July 4, 2021

First Submitted That Met QC Criteria

July 4, 2021

First Posted (ACTUAL)

July 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 研2019-363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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