Comparison of Metformin, Flutamide and Simvastatin Effects on Metabolic complications of Polycystic Ovary Syndrome

Comparison of Metformin, Flutamide + oral contraceptives and Simvastatin Effects on Metabolic complications of Polycystic Ovary Syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201405217513N10

Enrollment

111

Registered

2015-05-15

Start date

2013-04-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Polycystic Ovary Syndrome. polycystic Ovarian syndrome

Interventions

62.5mg Flutamid + low dose oral contraceptives ( OC ) per day

20mg Simvastatin per day

Intervention 1: 1000mg Meformin per day. Intervention 2: 62.5mg Flutamid + low dose oral contraceptives ( OC ) per day. Intervention 3: 20mg Simvastatin per day.

Treatment - Drugs

1000mg Meformin per day

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: age = 18 years; being single; having no evidence for thyroid dysfunction, Cushing syndrome, and hyperprolactinaemia; to have normal kidney function, bilirubin level, and serum aminotransferases; none-smoker; not having breast cancer; not using any drug which probably affects the Ovarian function; insulin sensitivity and lipid profile; No contraindication to use drugs. Exclusion criteria: to refuse to continue the study; marriage; emerging side drugs effects or contraindication; not to comply the study protocol.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Insulin resistance. Timepoint: baseline and after 6 month. Method of measurement: Homa-IR formula.;Fasting blood sugar. Timepoint: baseline and after 6 month. Method of measurement: mg/dl.;C-reactive protein. Timepoint: baseline and after 6 month. Method of measurement: mg/liter.;Blood pressure. Timepoint: baseline and after 6 month. Method of measurement: Blood pressure > 130/85 (mmHg).	—

Secondary

Measure	Time frame
BMI. Timepoint: baseline - after 6 month. Method of measurement: weight (kg)/ height square (m).;Waist circumference. Timepoint: baseline - after 6 month. Method of measurement: cm.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahboobe Mohamadkhani

School of Medicine

mohamadkhani88m@yahoo.com+98 913 319 8493

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026