NCT04204044

Comparison of Myoinositol and Metformin in PCO

A Comparative Study of Myo Inositol and Metformin in Improving Biochemical and Clinical Profile of Patients With Polycystic Ovarian Syndrome; a Randomized Clinical Trial

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Rashid Latif Medical College · Academic / Other
• Sex: Female
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

Aim of the study is to compare the effect of myoinositol and metformin in the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea, reduction in weight and BMI, Improvement in the biochemical and clinical profile of patients with the polycystic syndrome. The secondary outcome measured will be the rate of pregnancy, miscarriage and term pregnancy among these patients inducted in the study. It will be a Three-arm prospective double-blind study. this clinical trial will be registered in Public registry. this RCT will be based on CONSORT statement. The patient coming to Gynecology OPD will be randomized into 3 groups GROUP A ( metformin 500 mg TDS), GROUP B( myoinositol 2mg x BD ), GROUP C.(both metformin,\& myoinositol).each group will take folic acid and will be asked for lifestyle modifications.

Detailed description

PCOS is a common endocrine disorder in women of reproductive age associated with insulin resistance. Metformin and Myo-inositol being insulin sensitizers improve biochemical parameters. it is aimed to compare the effect of myoinositol and metformin in the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea, reduction in weight and BMI, Improvement in the biochemical and clinical profile of patients with the polycystic syndrome. Inclusion criteria: will be based on the Rotterdam criteria of diagnosing PCO. Patients presenting with a history of secondary amenorrhea, irregular menstrual cycle, oligomenorrhea, weight gain, hirsutism, and already diagnosed cases of PCO will be included in this group. Patients with history of Hyperprolactinemia, Cushing's disease, Hypothyroidism/ Hyperthyroidism, Pregnancy and nursing, Established type 1 or type 2 diabetes mellitus, Any history of drug intake e.g. anti-diabetic or estrogen and progesterone, History of treatment for the same complaint taken in the last 3 months, Unable to come for regular follow-ups, Any pathological cause of bleeding e.g. Fibroid, Polyp, Cervical pathology and known allergic to these drugs would be excluded.

Conditions

• PCOS

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride	Metformin Hydrochloride is used in PCO
DRUG	Myo-inositol	Myo inositol used in PCO

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-05-31
• Completion: 2021-07-25
• First posted: 2019-12-18
• Last updated: 2020-10-27

Locations

1 site across 1 country: Pakistan