polycystic ovary syndrome
Conditions
Interventions
The study will be conducted at the department of Pharmacology, Faculty of medicine, University of Peradeniya, Sri Lanka.
Consenting patients meeting inclusion/exclusion criteria will be randomized int
Sponsors
University Grants Commission, Sri Lanka
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than 18 years and less than 40 years 2. Diagnosis of PCOS according to the 2003 Rotterdam Consensus conference criteria 3. One or more of the following dermatological manifestations of hyperandrogenism: hirsutism, androgenetic alopecia, acne
Exclusion criteria
Exclusion criteria: 1. Smoking, alcoholism, drug addiction 2. Current pregnancy. 3. Current or previous use (up to three months before the study) of oral, vaginal, monthly injectable, or transdermal combined hormonal contraceptives 4. Current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant, or intrauterine device) 5. Current use of antiandrogens, hypoglycemic drugs, statins 6. Presence of systemic diseases (diabetes mellitus, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital adrenal hyperplasia) 7. Personal history of arterial or venous thrombosis 8. Puerperium of 24 weeks or less 9. Psychiatric illness or on anti-psychotic drugs 10. Renal disease 11. Migraine 12. Other causes of hyperandrogenism 13. Women wishing to conceive during the next 12 months 14. Personal or family history of breast carcinoma 15. Women with contraindications to use oral contraceptives (WHO criteria) and metformin 16. Inability to give the informed consent 17. History of metformin use within the previous 8 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hirsuitism as measured by 1.1.Objective hair measures Patients will be instructed not to remove hair by any means at least 5 days before the measurements. They will be asked to keep a note on date of hair removal before performing the hair removal. On the day of the measurements, the date and time of the last shaving will be recorded to establish the shaving interval (days). The primary investigator, who will be blinded, will obtain all measures. 1.2.Hair growth rate At least three photographs of the cheek/chin areas will be taken at each study time, using a digital camera. 1.3.Plucking. After photography, five cheek or chin hairs will be plucked with regular facial tweezers. The hair samples will then be fixed to a glass slide using Histomount mounting medium in xylene and will be protected with a cover slip. Using an overhead projector, the hair will be projected onto a screen, where they will be traced on paper. The total length of the hair will be measured using a digital plan measure. To calibrate the overhead projection, a stage micrometer will be projected onto the screen and traced. Each of the projected hair lengths will be then converted to actual millimeters. The results of the five hairs measured at each study time will be averaged to produce one mean length. This value will be divided by the shaving interval (in days) to get the hair growth rate (mm/day) 1.4.Hair diameter The diameter of each of the plucked hair will be obtained using an Olympus B× 50 magnification and image will be projected onto a monitor screen. Using a ruler in millimeters, the outer diameter of the hair at mid shaft will be obtained and will be converted to actual millimeters by comparing it to the projected screen micrometer. The diameters of the five hairs obtained at each study time will be averaged to take the mean. These measures will be done at the department of Pathology, Faculty of Medicine, University of Peradeniya, Sri Lanka. 1.5.Hair density Using the photograph | — |
Secondary
| Measure | Time frame |
|---|---|
| Waist circumference 2. Waist to height ratio 3. Body mass index 4. menstrual cyclicity – number of cycles per year and menstrual flow 5. Blood pressure 6. Side effect profile of drugs 7. Health related Quality of life – Polycystic Ovary Syndrome Questionnaire ( Singhalese translation ) 8. Oral glucose tolerance test (OGTT)- beginning and at the end of the study 9. Measurement of fasting blood glucose , insulin levels and Homeostasis Model Assessment (HOMA) index 10. Plasma adipokines ( leptin and adiponectin) 11. Lipid profile 12. Total testosterone ( early morning , between 4th and 10th day of menstrual cycle or women with amenorrhea) 13. Sex hormone binding globulin(SHBG) 14. Free androgen index [total testosterone (nM)/SHBG (nM) × 100] 15. Endometrial thickness 16. Liver enzymes – SGOT/ SGPT 17. Ultra sound scan of liver to detect fatty liver [Outcomes 1- 7 and 16 at the beginning of the study, at the end of 3rd month, at the end of 6th month, at the end of 9th month, at the end of 12th month Outcomes 8-15 and 17 at the beginning and at the end of 12th month ] | — |
Countries
Sri Lanka
Contacts
Public ContactSanjeewani Fonseka
lecturer
Outcome results
None listed