Status:
COMPLETED
Effects of Triple Drug Cocktail Therapy on Metabolic, Endocrine Alterations and Perceived Stress in Patients With Poly Cystic Ovary Syndrome
Lead Sponsor:
Khyber Medical University Peshawar
Conditions:
PCOS
Eligibility:
FEMALE
15-45 years
Phase:
PHASE2
Brief Summary
The investigators aim is to conduct a double blind randomized clinical trial, to study the effects of triple drug cocktail (metformin, pioglitazone and acetyl L-Carnitine) therapy on metabolic, endocr...
Detailed Description
Polycystic Ovarian Syndrome (PCOS) is an endocrinopathy which affects 5-10% of reproductive age women (1). The three main features of the syndrome are polycystic ovaries, high levels of androgen in bl...
Eligibility Criteria
Inclusion
- Treatment naive PCOS women having age from 14-45 years with scanty or no menstruation, hirsutism and elevated serum androgen levels, will be diagnosed on the basis of AES (Androgen access society) guidelines 2006 according to which when two of the following criteria are present patient will be said to have the syndrome
- Hirsutism or hyperandrogenism
- Oligo or an-ovulation and or polycystic ovaries -
Exclusion
- Women with previous history of Cushing syndrome
- Thyroid disorders
- Hyperprolactinemia
- Ovarian tumors
- Congenital adrenal hyperplasia androgen-producing tumors,
- History of seizures
- Patients on warfarin, Coumadin and Sintrom because of drug interaction with acetyl-L-Carnitine,
- Pregnancy or using contraceptive medications,
- Patients on hormonal therapy that alters the biochemical or hormonal profile
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2020
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT04113889
Start Date
October 15 2019
End Date
January 30 2020
Last Update
February 5 2020
Active Locations (1)
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1
Gynecology and Obstetric, Hayatabad Medical Complex
Peshawar, Khyber Pukhtunkhwa, Pakistan, 25000