Effect of Metformin Therapy on Serum Under-carboxylated Osteocalcin Levels in Hyperandrogenic Lean Polycystic Ovarian Syndrome Women
U-C OC IN PCOS
1 other identifier
interventional
100
1 country
1
Brief Summary
High ucOC may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity. Meformin is an insulin sensitizing agent will be given for these women trying to interfere with the pathophysiology of PCOS in these women as followed up by serum UC-OC levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2014
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 13, 2014
CompletedFirst Posted
Study publicly available on registry
September 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedFebruary 2, 2021
January 1, 2021
6.8 years
September 13, 2014
January 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
High Serum under-carboxylated osteocalcin
Hyperandrogenic lean women will be diagnosed as PCOS according to Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria.Serum uc-oc will be assayed when it is found to be high, metformin therapy for three months will be given to these women. Serum uc-oc will be measured again and effect of therapy will be interpreted.
3 months
Secondary Outcomes (1)
Metformin therapy
3 months
Study Arms (3)
Metformin
ACTIVE COMPARATORCidophage 850 mg twice daily for three months will be given to the patientwith PCOS.
Serum under-carboxylated osteocalcin
ACTIVE COMPARATORSerum uc-oc will be measured before and after 3 months of treatment with cidophage.
Placebo
ACTIVE COMPARATOROther group of patients with high serum UC-OC will be given a placebo.
Interventions
This drug is insulin sensitizing agent which will be given twice daily orally for 3 months for PCOS patients.
Serum uc-oc is a bone biomarker involved in incraesing insulin in pathophysiology of PCOS. It will be measured in serum of pcos patients before and after treatment with metformin for 3 months.
This group of patients will receive any type of vitamin as a placebo to compare with effect of Metformin on serum UC-OC.
Eligibility Criteria
You may qualify if:
- Lean women BMI 25 or less
- Hyperandrogenic clinically and/or biochemically.
- Androgen Excess-Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria
You may not qualify if:
- BMI more than 20
- Other causes of hyperandrogenism
- Other causes of metabolic disorders or diabetes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beni-Suef Universitylead
- Cairo Universitycollaborator
Study Sites (1)
Nesreen Abdel Fattah Abdullah Shehata
Cairo, Egypt
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Obstetrics and Gynecology
Study Record Dates
First Submitted
September 13, 2014
First Posted
September 19, 2014
Study Start
September 1, 2014
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
February 2, 2021
Record last verified: 2021-01