Effect of two oral contraceptives and metformin on excessive hair growth and other metabolic and hormonal parameters of patients with polycystic ovary syndrome
- Conditions
- polycystic ovary syndrome
- Registration Number
- SLCTR/2015/007
- Lead Sponsor
- niversity Grants Commission, Sri Lanka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method