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

NCT04962386 | Unknown

• 1 other identifier: 研2019-363
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• Tear secretion

  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 Outcomes (2)

• Noninvasive tear break-up time test (NITBUT)

  3 months

• The scoring of corneal fluorescein staining

  3 months

Study Arms (2)

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

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

Interventions

Hormone replacement therapy DRUG

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.

Also known as: Received estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV, Weesp, The Netherlands)

Perimenopausal women who did not undergo HRT; Perimenopausal women who did undergo HRT

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Perimenopausal women who did not undergo HRT

You may not qualify if:

• (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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (2)

Hangzhou Obstetrics and Gynecology Hospital

Hangzhou, Zhejiang, 350051, China

RECRUITING

Second Affiliated Hospital of Zhejiang University Hospital

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Hormone Replacement Therapy; Estradiol

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jin x ming, phd

  Second Affiliated Hospital of Zhejiang University Hospital

  STUDY DIRECTOR

Central Study Contacts

jin x ming, phd

CONTACT

18757163724; 18757163724@163.com

qin qi yu, md

CONTACT

18344980414; 18344980414@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 15, 2021
• Study Start: March 6, 2019
• Primary Completion: March 6, 2022
• Study Completion: March 6, 2022
• Last Updated: September 13, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)