PCOS
Conditions
Brief summary
This study is undertaken to compare the effects of treatment with commonly used OCP containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and they will be correlated with changes in hormonal parameters post-treatment.
Interventions
DRUGEthinyl Estradiol-cyprosterone acetate
Ethinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants.
DRUGMetformin Hydrochloride
Metformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants.
Sponsors
S.C.B. Medical College and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Women diagnosed with PCOS according to the Rotterdam criteria
Exclusion criteria
* Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs. * Medical or surgical treatment of PCOS during the previous 3 months * Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone * Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months) * Inability to understand the proposal of the study precluding effective informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in ovarian stromal blood flow by using Doppler | 6 months | By means of color and power Doppler flow imaging, color signals will be searched in the ovarian stroma away from the ovarian surface and not adjacent to the wall of a follicle. Areas of maximum color intensity, representing the greatest Doppler frequency shifts, will be chosen for pulsed Doppler examination. |
Secondary
| Measure | Time frame |
|---|---|
| Change in BMI as measured in kg/m2 | 6 months |
| Improvement in menstrual cycle pattern | 6 months |
| Change in waist circumference (cm) | 6 months |
| Change in blood level of luteinizing hormone [LH] (mIU/ml) and follicle stimulating hormone [FSH] (mIU/ml) | 6 months |
| Change in blood level of Testosterone (nmol/L) | 6 months |
| Improvement in hirsutism measured by Modified Ferriman and Gallwey scores | 6 months |
| Change in blood levels of Dehydroepiandrosterone sulfate (DHEAS) level (microgram/dl) | 6 months |
| Changes in fasting serum insulin levels (mIU/L) | 6 months |
| Changes in fasting serum glucose levels (mg/dL) | 6 months |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 6 months |
| Change in blood level of Sex hormone binding globulin (SHBG) (ng/ml) | 6 months |
Countries
India
Outcome results
None listed