Clinical trial NCT04204044: Comparison of Myoinositol and Metformin in 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: PCOS
Lead sponsor: Rashid Latif Medical College
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 126
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: GROUP A ( Metformin 500 mg TDS), GROUP B( Myoinositol 2000 mg x BD ), GROUP C.(both metformin,\& myoinositol)
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Menstrual cycle regulation
timeFrame: Follow up at 3rd and 6th months
measure: change in weight
timeFrame: Follow up at 3rd and 6th months
Secondary outcomes:
measure: Pregnancy / Miscarriage
timeFrame: 1 year
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Rashid Latif Medical College
state: Punjab
Study officials:
affiliation: rlmc lahore
name: LAMIA YUSUF, FCPS,MHPE
role: PRINCIPAL_INVESTIGATOR
References: