The Effects of OCP and Metformin on Clinical, Hormonal, Metabolic and Ultrasonographic Characteristics in PCOS

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorder in women of reproductive age and is a leading cause of infertility due to anovulation. Oral contraceptive pills (OCPs) are considered as first line medical therapy to regularize menses in woman with PCOS. However they may worsen the metabolic profile of patients by elevating insulin resistance which is already deranged in PCOS. As there is higher prevalence of insulin resistance in Indian women with PCOS, insulin sensitisers like metformin may be more beneficial. Hence this study is undertaken to compare the combined effect of metformin and OCPs on the clinical, hormonal, metabolic and ovarian ultrasonographic characteristics in patients with PCOS and to evaluate whether this combination of drugs is more advantageous than OCPs or metformin alone in improving the clinical and metabolic profile.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: S.C.B. Medical College and Hospital
• Treatments: Contraceptives, Oral; Contraceptives, Oral, Combined; Cyproterone; Cyproterone Acetate; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Metformin; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Patients will be included into study who fulfill the Rotterdam diagnostic criteria (2003) for PCOS.

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