Singapore Population Research on Integrated exposoMe & Early Menopause

NCT07100639 | Not Yet Recruiting DMC

• 2 other identifiers: 2050-50MOH-001786-00
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Brief Summary The goal of this observational study is to learn how environmental factors, lifestyle choices, and social conditions affect the timing of menopause in Asian women aged 40-50 years living in Singapore. The main aims of the project are the following:

• Do environmental pollutants and lifestyle exposures contribute to earlier menopause in Asian women?
• What biological changes occur when women are exposed to harmful environmental factors during menopause transition? Participants will be followed for 18 months and will complete questionnaires about their health history, lifestyle, diet, and environmental exposures. Participants will provide blood, urine, stool, hair, and nail samples for laboratory analysis and undergo basic health assessments including weight, blood pressure, and bone density measurements. Participants will wear activity monitors and air pollution sensors for 7 days and attend follow-up visits at 6 months, 12 months, and 18 months to track changes in their health. This data will be obtained during the baseline visit.

Conditions

Early Menopause

Keywords

early menopause; environment; pollution; exposome

Outcome Measures

Primary Outcomes (2)

• Early menopause

  18 months

• Time to menopause onset

  • Menopausal symptom severity score using standardized assessment tools

  18 months

Study Arms (1)

SG-PRIME

no interventions

Eligibility Criteria

• Age: 40 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women experiencing perimenopausal transition characterized by irregular menstrual patterns and hormonal fluctuations, stratified by age groups (40-45 years and 46-50 years) and ethnicity to ensure representative sampling of Singapore's multi-ethnic population.

You may qualify if:

• Female participants aged 40-50 years No menstruation for the last 2 months or irregular menstrual cycles in the last 6 months Chinese, Malay, or Indian ethnicity Proficient in English language Planning to reside in Singapore for next 2 years Willing to provide informed consent and comply with study procedures

You may not qualify if:

• In menopause (12 consecutive months without menstruation) Currently pregnant or planning to conceive History of bilateral oophorectomy and/or hysterectomy Currently receiving hormone therapy, including estradiol replacement therapy or oral contraceptives Diagnosed with premature ovarian insufficiency before 40 years of age Diagnosis of autoimmune conditions and/or chromosomal abnormalities known to affect ovarian function Diagnosis of severe cognitive impairment and/or mental disorders Received cancer treatment in the past 12 months

Sponsors & Collaborators

• Institute for Human Development and Potential (IHDP), Singapore: lead

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Narasimhan Kothandaraman, Ph.D

CONTACT

+65 64074057; Kothandaraman_Narasimhan@sics.-astar.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 3, 2025

Record last verified: 2025-07