Effects of metformin plus rosuvastatin on hyperandrogenism in polycystic ovary syndrome patients with hyperlipidemia and impaired glucose tolerance

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000886987

Acronym

Enrollment

Registered

2011-08-19

Start date

2009-05-05

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Objective: We aimed to compare the effects of metformin and metformin plus rosuvastatin combination therapies on hyperandrogenism in patients with polycystic ovary syndrome (PCOS). Design: A prospective, randomized study. Setting: University hospital. Patients: Thirty-eight PCOS patients with hyperlipidemia and impaired glucose tolerance (IGT) were included in the study. Interventions: Patients were assigned to receive lifestyle intervention and metformin (2000mg/day, n= 20, M group) therapy or lifestyle intervention, metformin (2000mg/day) plus rosuvastatin therapies (10 mg/day rosuvastatin, n= 18, MR group) for 12 weeks. Blood samples were obtained before and after treatment. Main Outcome Measures: Total and free testosterone, insulin, glucose and hs-CRP levels. Results: After 12 weeks of treatment body mass index (BMI), insulin and glucose levels, HOMA-IR had similar decreaments in both groups (p= 0.5, p=0.97, p=0.74, p=0.94), whereas there was a greater decline of the total and free testosterone levels in MR group (p< 0.001, p= 0.004). DHEAS levels did not change in M group however significantly decreased in MR group after treatment (p=0.8, p=0.002). As expected hsCRP, triglyceride, total and LDL- cholesterol levels decreased more in MR group. Conclusion: Metformin and rosuvastatin combination therapy was proved to have more favorable effect on hyperandrogenism. Therefore statin therapy in PCOS patients with hyperlipidemia and higher cardiovascular risk can render hyperandrogenism treatment more successful.

Interventions

Group MR : Lifestyle intervention ( 1 hour sessions / 2 times a week moderately physical activity and exercise, indivudial dietary modification monitoring by a dietitian ), plus metformin (2000mg/day, peroral) plus rosuvastatin therapies (10 mg/day rosuvastatin, per oral, n= 18) for 12 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

PCOS was defined according to Rotterdam European Society for Human Reproduction and Embryology (ESHRE) and the American Society for Reproductive Medicine(ASRM) consensus workshop. All patients had at least two of the following three criteria: chronic anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovaries on ultrasound (USG).

Exclusion criteria

The patients who had liver and kidney diseases and using drugs affecting insulin sensitivity and lipid profile and oral contraceptives within the last six months were excluded from the study. Patients with Cushing's syndrome, hyperprolactinemia, diabetes mellitus, thyroid disease, congenital adrenal hyperplasia and androgen-secreting tumors, insufficient LH syndrome and other endocrinopathies were also excluded from the study.

Outcome results