To compare Inositol with oral contraceptive pills on menstrual regulation in young girls with PCOS.
- Conditions
- Health Condition 1: null- Polycystic Ovary Syndrome (PCOS)
- Registration Number
- CTRI/2018/03/012643
- Lead Sponsor
- Department of Obstetrics Gynaecology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Young girls in the age-group of 15-24 years (or atleast 2 years after the onset of menarche) with PCOS diagnosed by two out of the following criteria
a) Hyperandrogenism - Clinical(hirsutism
diagnosed by modified Ferriman -Gallwey
score more than or equal to 8/36) or
Biochemical (serum testosterone >0.5 ng/L)
b) Persistent oligo/anovulation characterized
by irregular menstrual cycles (19-90 days)
or absent menstrual cycles ( for a period
equivalent to previous 3 menstrual cycles)
c) Polycystic ovaries on ultrasound diagnosed
when ovarian volume more than 10 cu.cm.
d) Insulin resistance
2) Patients who are willing to give consent for
the study and willing for follow-up.
1) Pregnancy.
2) A known case of diabetes mellitus.
3) Patients who are taking or had taken any
hormonal treatment including contraceptives
over the past 3 months.
4) Patients who are taking or who had used
glucocorticoids, lipid-lowering drugs,
glucose-lowering drugs or anti-obesity drugs
within 3 months of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Menstrual cycle length <br/ ><br> expressed as average of <br/ ><br> days between cycles. <br/ ><br>2.Modified Ferriman- Gallwey <br/ ><br> score and Acne scoring <br/ ><br>Timepoint: 6 months and 3 months after stopping treatment.
- Secondary Outcome Measures
Name Time Method 1.Ovarian volumeâ??lxbxw (cc) <br/ ><br>2.Change in Serum AMH, FSH, <br/ ><br> LH, Testosterone <br/ ><br>3.Changes in blood sugar <br/ ><br> profile, lipid profile <br/ ><br>4.Homeostatic Model <br/ ><br> Assessment (HOMA-IR) <br/ ><br>5.Compliance <br/ ><br>6.Body Weight <br/ ><br> <br/ ><br>Timepoint: 6 months and 3 months after stopping treatment