Efficacy of different drugs like Clomiphene with or without Metformin/ Pioglitazone/ Spironolactone in Polycystic Ovary syndrome.

Phase 4

Recruiting

• Conditions: Polycystic ovary syndrome

• Registration Number: CTRI/2012/08/002845
• Lead Sponsor: Dr Sunita J Ramanand

Brief Summary

Polycystic ovary syndrome (PCOS ) is one of the most common endocrinological disorders, may present with amenorrhea, infertility, hyperandrogenism, metabolic disturbances like insulin resistance, dyslipidemia.  Presence of insulin resistance, obesity, dyslipidemia places them in high risk of developing diabetes and cardiovascular disorders.Ovulation inducers like Clomiphene  are first line drugs in PCOS, insulin sensitizers like  metformin, Thiazolidinediones  like Pioglitazone and antiandrogens  like Spironolactone  can be of help in PCOS.Previous multiple studies have compared Clomiphene with metformin, Pioglitazone and its combination with these drugs . Present research   plans to do compare these drugs alone or in combination in a single study.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-29
• Last Update Posted: 2012-06-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• A) Clinical criteria: 1.oligomenorrhea or menstrual disturbances 3.S/S of Hyperandrogenism viz, acne, hirsuitism, alopecia.
• 4.Acanthosis nigricans.
• B) Hormonal criteria: 1.LH/FSH ratio >1.5 2.Serum Testosterone >1.1 ng/ml C) Abdominal USG: At least 10 follicles (2-8 mm in diameter) arranged peripherally around a dense core of ovarian stroma or scattered throughout an increased amount of stroma.
• Patient of PCOD having hypothyroidism will be treated with thyroxine.
• After achieving euthyroid states, patient will be included in the study.

Exclusion Criteria

• 1)Systemic diseases- Renal, hepatic cardiac, RS , frank DM, hypertension , congenital adrenal hyperplasia, ,hyperprolactinemia, acromegaly, functional hypothalamic amenorrhea.
• 2)Past H/O lactic acidosis.
• 3)Patients undergoing IV contrast media study or surgical procedures.
• 4)BMI ( >30 mg/) kg.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Regularisation of menses	3 months

Secondary Outcome Measures

Name	Time	Method
Improvement in clinical features of PCOS	3 months

Trial Locations

Locations (1)

Room no 1 , Research Lab,Department of Pharmacoogy,Government Medical College Miraj; 🇮🇳 Sangli, MAHARASHTRA, India

Room no 1 , Research Lab,Department of Pharmacoogy,Government Medical College Miraj

🇮🇳Sangli, MAHARASHTRA, India

Dr Sunita J Ramanand

Principal investigator

09850547900

pharmac.ctri@gmail.com