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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Heilongjiang University of Chinese Medicine
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01116167
First received: April 27, 2010
Last updated: May 17, 2013
Last verified: May 2013

April 27, 2010
May 17, 2013
October 2009
December 2013   (final data collection date for primary outcome measure)
Live-birth rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Pregnancy Rates [ Time Frame: within 6 calendar months of randomisation ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01116167 on ClinicalTrials.gov Archive Site
  • Ovulation rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Ongoing pregnancy rate at around gestation 8-10 weeks [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Multiple pregnancy rate [ Time Frame: Up to 1 year. ] [ Designated as safety issue: No ]
  • Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Infant outcome [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Changes in metabolic profile: glucose and insulin concentrations, cholesterol, triglycerides, high density lipoprotein (HDL-C) and low density lipoprotein (LDL-C) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Changes in hormonal profile: Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), total testosterone (T), Sex hormone-binding globulin (SHBG) and Dehydroepiandrosterone sulfate (DHEAS) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Side effect. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Ovulation rate and Abortion rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Live-birth rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine
Letrozole and Berberine in Infertile PCOS Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
  • 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.

  • Experimental: Letrozole -Berberine
    Intervention: Drug: Letrozole -Berberine
  • Active Comparator: Letrozole
    Intervention: Drug: Letrozole
  • Active Comparator: Berberine
    Intervention: Drug: Berberine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
660
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chinese women
  • Age between 20 and 40 years.
  • Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 out of 3):

    1. Oligo- or anovulation
    2. Clinical and/or biochemical signs of hyperandrogenism
    3. Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)
  • At least one patent tube and normal uterine cavity shown by hysterosalpingogram, HyCoSi or diagnostic laparoscopy within three years.
  • Sperm concentration 20×106/mL and progressive motility (grades a and b) ≥50%.

Exclusion Criteria:

  • Use of hormonal drugs or other medications including Chinese herbal prescriptions in the past 3 months.
  • Patients with known sever organ dysfunction or mental illness.
  • Pregnancy, post-abortion or postpartum within the past 6 weeks.
  • Breastfeeding within the last 6 months.
  • Not willing to give written consent to the study.
Female
20 Years to 40 Years
No
Contact: Yan Li, MD.PhD. liyantcm@163.com
China
 
NCT01116167
you070316
No
Xiaoke Wu, Heilongjiang University of Chinese Medicine
Heilongjiang University of Chinese Medicine
Ministry of Science and Technology of the People´s Republic of China
Study Chair: Lihui Hou, MD. The First Affliated Hospital,Heilongjiang University of Chinese Medicine .
Study Chair: Xiaoke Wu, MD.PhD. The First Affliated Hospital,Heilongjiang University of Chinese Medicine
Heilongjiang University of Chinese Medicine
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP