Metformin Versus Myo-inositol in the Management of Polycystic Ovarian Disease: A Comparative Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- LH/FSH ratio
研究概览
简要总结
In polycystic ovary syndrome (PCOS), changes in physical appearance i.e. weight gain, hirsutism, menstrual disturbances and infertility result in reduced quality-of-life. PCOS is one of the most common endocrine disorders affecting about 4% to 8% of women of reproductive age. Diagnosis is primarily clinical with Rotterdam criteria being the most commonly followed criteria, which require the presence of two out of the three criteria including oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries on ultrasound.
The objective of this study is to compare the outcome of Metformin versus Myo-inositol in the management of polycystic ovarian disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Married or unmarried
- •Diagnosed with PCOS (females presenting with compliant of irregular cycle for >3 months, with hirsutism, acne, presence of polycystic ovaries detected on ultrasound ).
排除标准
- •Females already taken or taking PCOS treatment (on medical record)
- •Females already enrolled in another trial program
- •Females already taking trial drugs
- •Females with chronic diabetes (BSR>200 mg/dl), hypertension (BP≥140/90mmHg)
- •Females with PCOS along with gestational sac (on ultrasound)
- •Females allergic to any content of trial drugs (on history)
研究组 & 干预措施
In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months
Informed consent will be obtained from each female. Demographic data (name, age, height and weight for BMI, duration of symptoms (irregular cycles from how many months), marital status, parity, residence, socioeconomic status, diet pattern, family history of PCOS, and life style will be recorded. Females will be asked for their menstrual cycle duration and irregularity. Females will be prescribed oral myoinositol 1g twice daily for 3 months. All females will be followed-up in OPD for 3 months. After 3 months, females will be asked for their menstrual cycle duration and regularity. Reports will be assessed and levels will be recorded. If females will have regular cycles, then it will be noted. Females will be asked to give a blood sample on 3rd day of menstrual cycle and LH/FSH ratio will be noted. All this data will be recorded in a specially designed proforma
干预措施: Myoinositol (Drug)
In group B, females will be prescribed oral metformin 850 mg twice daily for 3 months
Informed consent will be obtained from each female. Demographic data (name, age, height and weight for BMI, duration of symptoms (irregular cycles from how many months), marital status, parity, residence, socioeconomic status, diet pattern, family history of PCOS, and life style will be recorded. Females will be asked for their menstrual cycle duration and irregularity. Females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months. All females will be followed-up in OPD for 3 months. After 3 months, females will be asked for their menstrual cycle duration and regularity. Reports will be assessed and levels will be recorded. If females will have regular cycles, then it will be noted. Females will be asked to give a blood sample on 3rd day of menstrual cycle and LH/FSH ratio will be noted. All this data will be recorded in a specially designed proforma.
干预措施: Metformin (Drug)
结局指标
主要结局
LH/FSH ratio
时间窗: 3 Months
It will be assessed in terms of ratio between LH and FSH after 3 months of treatment.
Regular cycles
时间窗: 3 Months
It will be labeled if number of days from the start (day 1) of one period until the start (day 1) of the next period are almost equal for at least 3 months
次要结局
未报告次要终点
研究者
Fatima Tariq
Principal Investigator
Combined Military Hospital Gujranwala