NCT01116167

Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine

Letrozole and Berberine in Infertile PCOS Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: Heilongjiang University of Chinese Medicine · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Polycystic ovary syndrome (PCOS) is a heterogeneous disorder affecting almost4%-7% of the female population of reproductive age. Its heterogeneity is characterized by a wide spectrum of features, including ovulatory dysfunction and infertility, hyperandrogenism, hyperinsulinemia, insulin resistance (IR), and progression to type 2 diabetes.Since the Ming Dynasty in China,PCOS has been defined as "phlegm and wetness"infertility in traditional Chinese medicine ,namely "metabolic infertility".Chinese herbs have been used to treat PCOS for thousands of years with good effects.Berberine has also been used for diabetic patients in traditional Chinese medicine for hundreds of years. Recent studies have reported its effects on hyperglycemia and dyslipidemia.The purpose of this study is to determine whether Letrozole combined with berberine are effective in the treatment of infertile PCOS patients.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Letrozole -Berberine	Letrozole 2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6. Berberine 1.5g daily for 6 month.
DRUG	Letrozole	Letrozole 2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6. Berberine Placebo 5 tablet tds for 6 months
DRUG	Berberine	Berberine 1.5g daily for 6 month. Letrozole placebo 1 tablet daily from day 5 of the menses for 5 days for month 1 to 3, 2 tablets daily from day 5 of the menses for 5 days for month 4 to 6.

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-05-04
• Last updated: 2013-05-20

Locations

18 sites across 1 country: China