Comparison of Myoinositol and Metformin in PCO (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

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.

Study Overview

• Status: Unknown
• Conditions: PCOS
• Intervention / Treatment: Drug: Metformin Hydrochloride; Drug: Myo-inositol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54200
      • Rashid Latif Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

It 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.

Exclusion Criteria:

• 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
• Known allergic to these drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GROUP A ( metformin 500 mg TDS); Life style modifications, Weight reduction and folic acid will be prescribed with metformin 500 mg three times a day	Drug: Metformin Hydrochloride; Metformin Hydrochloride is used in PCO; Other Names: Folic acid
Experimental: GROUP B( myoinositol 2000mg x BD ); Life style modifications, Weight reduction and folic acid will be prescribed with myoinositol 2000 mg two times a day	Drug: Myo-inositol; Myo inositol used in PCO; Other Names: Folic Acid
Experimental: GROUP C.(both metformin,& myoinositol); Life style modifications, Weight reduction and folic acid will be prescribed with both metformin,& myoinositol three and two times a day respectively	Drug: Metformin Hydrochloride; Metformin Hydrochloride is used in PCO; Other Names: Folic acid; Drug: Myo-inositol; Myo inositol used in PCO; Other Names: Folic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual cycle regulation	In the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea.Improvement in the biochemical and clinical profile of patients with the polycystic syndrome	Follow up at 3rd and 6th months
change in weight	change in weight and BMI. Weight in Kg(s) and height will be measured in meter(s). BMI will be calculated by dividing weight in Kg with height in meter square	Follow up at 3rd and 6th months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy / Miscarriage	The secondary outcome measured will be the rate of conception/pregnancy, miscarriage and term pregnancy among these patients inducted in the study.	1 year

Collaborators and Investigators

• Sponsor: Rashid Latif Medical College
• Investigators: Principal Investigator: LAMIA YUSUF, FCPS,MHPE, rlmc lahore

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): May 31, 2021
• Study Completion (Anticipated): July 25, 2021

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 25, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Micronutrients; Vitamins; Hematinics; Metformin; Folic Acid; Vitamin B Complex; Inositol
• Other Study ID Numbers: IRB/2019/027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No