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Effect of Flutamide and Metformin administered in dieting overweight-obese women with polycystic ovary syndrome

Effect of Flutamide and Metformin administered in dieting overweight-obese women with polycystic ovary syndrome

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138807271760N3
Enrollment
80
Registered
2010-05-21
Start date
2008-05-21
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

Polycistic overian syndrome. Polycistic overian syndrome

Interventions

Intervention 1: Flutamide and/or Metformin. Intervention 2: Hypocaloric dieting. Intervention 3: Placebo.
Treatment - Drugs
Lifestyle
Placebo
Flutamide and/or Metformin
Hypocaloric dieting

Sponsors

Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Reproductive age (range 18-45 yr), body mass index (BMI) at least 28 kg/m2, and waist circumference at least 88 cm, chronic an ovulation severe oligomorrhea or amenorrhea, hirsutism (Ferriman – Gallwey score 8), total testosterone levels at least 0.72 ng/ml and polycystic ovarian morphology at ultrasound. Exclusion criteria: Use of any medication or a significant modification in body weight within the previous 3 months or dieting, hyperprolactinemia, cushing’s syndrome, late–onset congenital adrenal hyperplasia, thyroid dysfunction, diabetes, cardiovascular, renal or Liver diseases, positive pregnancy test.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Anthropometric measurement. Timepoint: monthly. Method of measurement: physical examination.

Secondary

MeasureTime frame
Serum Lipid. Timepoint: monthly. Method of measurement: Lab.;Serum glucose. Timepoint: monthly. Method of measurement: lab.;Fasting insulin. Timepoint: 6 months. Method of measurement: lab.;Testosteroe, OHEA, SHBG. Timepoint: 6 months. Method of measurement: lab.;Hirsotism. Timepoint: 6 months. Method of measurement: physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNargess Gholizadeh Pasha

Fatemehzahra Fertility & reproductive Health Research Center

ngh_pa@yahoo.com+98 11 1227 4881

Outcome results

None listed

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