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Comparison of Myoinositol and Metformin in PCO

Sponsor
Rashid Latif Medical College (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04204044
Collaborator
(none)
126
Enrollment
1
Location
3
Arms
8.7
Anticipated Duration (Months)
14.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
GROUP A ( Metformin 500 mg TDS), GROUP B( Myoinositol 2000 mg x BD ), GROUP C.(both metformin,& myoinositol)GROUP A ( Metformin 500 mg TDS), GROUP B( Myoinositol 2000 mg x BD ), GROUP C.(both metformin,& myoinositol)
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Treatment will be assigned to each participant using lottery method
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
May 31, 2021
Anticipated Study Completion Date :
Jul 25, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Menstrual cycle regulation [Follow up at 3rd and 6th months]

      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

    2. change in weight [Follow up at 3rd and 6th months]

      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

    Secondary Outcome Measures

    1. Pregnancy / Miscarriage [1 year]

      The secondary outcome measured will be the rate of conception/pregnancy, miscarriage and term pregnancy among these patients inducted in the study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rashid Latif Medical College Lahore Punjab Pakistan 54200

    Sponsors and Collaborators

    • Rashid Latif Medical College

    Investigators

    • Principal Investigator: LAMIA YUSUF, FCPS,MHPE, rlmc lahore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lamia yusuf, Associate Professor, Rashid Latif Medical College
    ClinicalTrials.gov Identifier:
    NCT04204044
    Other Study ID Numbers:
    • IRB/2019/027
    First Posted:
    Dec 18, 2019
    Last Update Posted:
    Oct 27, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Folic Acid
    Vitamin B Complex
    Inositol
    Metformin

    Study Results

    No Results Posted as of Oct 27, 2020