Comparison of Myoinositol and Metformin in PCO

Rashid Latif Medical College

Status and phase: Unknown; Early Phase 1

Conditions: PCOS

Treatments: Drug: Metformin Hydrochloride; Drug: Myo-inositol

Study type: Interventional

Funder types: Other

Identifiers

NCT04204044

IRB/2019/027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: Female

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

126 participants in 3 patient groups

GROUP A ( metformin 500 mg TDS)

Experimental group

Description:

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

Treatment:

Drug: Metformin Hydrochloride

GROUP B( myoinositol 2000mg x BD )

Experimental group

Description:

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

Treatment:

Drug: Myo-inositol

GROUP C.(both metformin,& myoinositol)

Experimental group

Description:

Life style modifications, Weight reduction and folic acid will be prescribed with both metformin,\& myoinositol three and two times a day respectively

Treatment:

Drug: Myo-inositol

Drug: Metformin Hydrochloride