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

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ClinicalTrials.gov Identifier: NCT01116167
Recruitment Status : Unknown
Verified May 2013 by Xiaoke Wu, Heilongjiang University of Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : May 4, 2010
Last Update Posted : May 20, 2013
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

Brief 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Letrozole -Berberine Drug: Letrozole Drug: Berberine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Letrozole and Berberine in Infertile PCOS Patients
Study Start Date : October 2009
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: Letrozole -Berberine 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.


Active Comparator: Letrozole 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


Active Comparator: Berberine 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.





Primary Outcome Measures :
  1. Live-birth rate [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Ovulation rate [ Time Frame: Up to 1 year ]
  2. Ongoing pregnancy rate at around gestation 8-10 weeks [ Time Frame: Up to 1 year ]
  3. Multiple pregnancy rate [ Time Frame: Up to 1 year. ]
  4. Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation [ Time Frame: Up to 1 year ]
  5. 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 ]
  6. Infant outcome [ Time Frame: Up to 1 year ]
  7. 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 ]
  8. 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 ]
  9. Side effect. [ Time Frame: Up to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116167


Contacts
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Contact: Yan Li, MD.PhD. liyantcm@163.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Heilongjiang University of Chinese Medicine
Ministry of Science and Technology of the People´s Republic of China
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xiaoke Wu, Professor and Department Chairman of Obstetrics and Gynecology, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT01116167    
Other Study ID Numbers: you070316
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: May 20, 2013
Last Verified: May 2013
Keywords provided by Xiaoke Wu, Heilongjiang University of Chinese Medicine:
Polycystic Ovary Syndrome
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs