Comparison of Myoinositol and Metformin in PCO

PCOS Clinical Trial

— PCO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04204044
• Other study ID #: IRB/2019/027
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: November 1, 2020
• Est. completion date: July 25, 2021

Study information

• Verified date: October 2020
• Source: Rashid Latif Medical College
• Contact: LAMIA YUSUF, FCPS,MHPE
• Phone: 00923214549179
• Email: doclamia[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: July 25, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• PCOS

Intervention

Drug:
• Metformin Hydrochloride
Metformin Hydrochloride is used in PCO
• Myo-inositol
Myo inositol used in PCO

Locations

Country	Name	City	State
Pakistan	Rashid Latif Medical College	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Rashid Latif Medical College

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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