Status:
RECRUITING
Semaglutide in Women With Polycystic Ovary Syndrome and Obesity
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Conditions:
Polycystic Ovary Syndrome (PCOS) Women
Obesity
Eligibility:
FEMALE
10-45 years
Phase:
PHASE2
PHASE3
Brief Summary
Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder that is frequently associated with metabolic features, including obesity. Improvement of metabolic manifestations helps in the control o...
Detailed Description
Introduction Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder, impacting approximately 10-20% of women in their reproductive years. The syndrome is typically characterized by reprodu...
Eligibility Criteria
Inclusion
- Reproductive-aged women with PCOS diagnosed according to International evidence based guidelines 2023 and obesity
Exclusion
- Having DM, other significant systemic diseases- chronic kidney disease (eGFR \<60mL/minute/ 1.73 m2 BSA), chronic liver disease (ALT \>3 × ULN), and heart failure
- Patients having PCOS mimicking endocrine disorders (untreated thyroid dysfunctions, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, acromegaly, hypothalamic disorder etc.)
- Those taking any other weight loss medications (eg., orlistat, liraglutide) within the last 3 months
- Those who have undergone bariatric surgery
- Any conditions causing weight loss (thyrotoxicosis, Addison's disease, chronic infection, connective tissue disorder, cancer, etc)
- Secondary causes of obesity (major mood disorders, steroids, valproate, oral contraceptives, etc)
- Contraindications for semaglutide: personal or family history of medullary carcinoma of the thyroid, history of acute pancreatitis, gallbladder disease
- Planning for pregnancy or current pregnancy/ lactation
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06896981
Start Date
February 1 2025
End Date
December 31 2025
Last Update
April 2 2025
Active Locations (1)
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1
Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University
Dhaka, Dhaka Division, Bangladesh, 1000