An Early Phase 1 interventional study of Metformin Hydrochloride and Myo-inositol in PCOS, sponsored by Rashid Latif Medical College. Status unknown at 1 site in Pakistan. Open to female participants aged 16 Years to 35 Years. Per ClinicalTrials.gov, last updated 2020-10-27.
Sponsored by Rashid Latif Medical College · Early Phase 1, Interventional, and Treatment
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.
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.
Rashid Latif Medical College is the lead sponsor of 14 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Life style modifications, Weight reduction and folic acid will be prescribed with metformin 500 mg three times a day
Drug: Metformin Hydrochloride
Life style modifications, Weight reduction and folic acid will be prescribed with myoinositol 2000 mg two times a day
Drug: Myo-inositol
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
Metformin Hydrochloride is used in PCO
Also known as: Folic acid
Myo inositol used in PCO
Also known as: Folic Acid
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
Time frame: 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
Time frame: Follow up at 3rd and 6th months
Pregnancy / Miscarriage
The secondary outcome measured will be the rate of conception/pregnancy, miscarriage and term pregnancy among these patients inducted in the study.
Time frame: 1 year
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Rashid Latif Medical College