Comparison of Myoinositol and Metformin in PCO

NCT04204044 | Unknown Early Phase 1 DMC

• 1 other identifier: IRB/2019/027
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PCOS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pregnancy / Miscarriage

  1 year

Study Arms (3)

GROUP A ( metformin 500 mg TDS)

EXPERIMENTAL

Life style modifications, Weight reduction and folic acid will be prescribed with metformin 500 mg three times a day

Drug: Metformin Hydrochloride

GROUP B( myoinositol 2000mg x BD )

EXPERIMENTAL

Life style modifications, Weight reduction and folic acid will be prescribed with myoinositol 2000 mg two times a day

Drug: Myo-inositol

GROUP C.(both metformin,& myoinositol)

EXPERIMENTAL

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; Drug: Myo-inositol

Interventions

Metformin Hydrochloride DRUG

Metformin Hydrochloride is used in PCO

Also known as: Folic acid

GROUP A ( metformin 500 mg TDS); GROUP C.(both metformin,& myoinositol)

Myo-inositol DRUG

Myo inositol used in PCO

Also known as: Folic Acid

GROUP B( myoinositol 2000mg x BD ); GROUP C.(both metformin,& myoinositol)

Eligibility Criteria

• Age: 16 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rashid Latif Medical College: lead

Study Sites (1)

Rashid Latif Medical College

Lahore, Punjab Province, 54200, Pakistan

Location

MeSH Terms

Interventions

Metformin; Folic Acid; Inositol

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sugar Alcohols; Alcohols; Carbohydrates

Study Officials

• LAMIA YUSUF, FCPS,MHPE

  rlmc lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LAMIA YUSUF, FCPS,MHPE

CONTACT

00923214549179; doclamia@hotmail.com

Arslan Saleem, Masters

CONTACT

00923334585339; chughtai.arslan@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Treatment will be assigned to each participant using lottery method
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: GROUP A ( Metformin 500 mg TDS), GROUP B( Myoinositol 2000 mg x BD ), GROUP C.(both metformin,\& myoinositol)

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: December 18, 2019
• Study Start: November 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: July 25, 2021
• Last Updated: October 27, 2020

Record last verified: 2020-10

Locations

PA (1)