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Trial Title:
Serum Biomarker Levels Improvement in Poly Cystic Ovarian Syndrome: Impact of Metformin Compared to Healthy Controls
NCT ID:
NCT06479434
Condition:
Polycystic Ovary Syndrome
Insulin Resistance
Conditions: Official terms:
Polycystic Ovary Syndrome
Insulin Resistance
Syndrome
Metformin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Metformin
Description:
Females diagnosed with polycystic syndrome will be given metformin tablets for 8 weeks
and followed up. Blood samples will be collected along with anthropometric data (weight
(kg), height (m) etc)
Arm group label:
Metformin Treated PCO
Summary:
The goal of this interventional study is to assess the effect of drug metformin in
improving the fertility hormones and reducing the inflammatory hormones in polycystic
ovarian syndrome (PCOS) patients. We wish to answer the question whether metformin is
necessary to improve PCOS symptoms versus simple lifestyle modification.
Participants once diagnosed with PCOS will be given metformin to be sued for 8 weeks.
They will be asked to provide blood samples on day 0 and after 8 weeks of metformin use.
The blood sample will be used to measure the hormonal and inflammatory profile. In
addition, they will be required to compete a questionnaire regarding symptoms such as
decrease in facial hair growth, improvement in menstrual cycle etc.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
a) Patients Falling into PCOS as per Rotterdam criteria
Exclusion Criteria:
1. Systemic diseases like atherosclerosis,
2. Diabetes mellitus
3. Hypertension
4. congenital adrenal hyperplasia, androgen secreting tumors
Gender:
Female
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
DBBS
Address:
City:
Karachi
Zip:
74800
Country:
Pakistan
Status:
Recruiting
Contact:
Last name:
Sabah Research Coordinator, MPhil
Phone:
+9234864492
Start date:
June 24, 2024
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Aga Khan University
Agency class:
Other
Collaborator:
Agency:
University of Karachi
Agency class:
Other
Source:
Aga Khan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06479434
