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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Heilongjiang University of Chinese Medicine.
Recruitment status was:  Recruiting
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
  Purpose
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 Intervention
Polycystic Ovary Syndrome
Drug: Letrozole -Berberine
Drug: Letrozole
Drug: Berberine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Letrozole and Berberine in Infertile PCOS Patients

Resource links provided by NLM:


Further study details as provided by Heilongjiang University of Chinese Medicine:

Primary Outcome Measures:
  • Live-birth rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 660
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116167

Locations
China, Anhui
Affiliated Hospital of Anhui University of Chinese Medicine
Hefei, Anhui, China
China, Guangdong
Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangzhou Medical School First Affiliated Hospital
Guangzhou, Guangdong, China
China, Heilongjiang
Daqing LongNa Hospital
Daqing, Heilongjiang, China, 163000
Daqing Longnan hospital
Daqing, Heilongjiang, China
Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China, 150040
First Affliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Mudanjiang maternal and children hospital
Mudanjiang, Heilongjiang, China
China, Henan
2nd Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
China, Hunan
First Affiliated Hospital of Hunan University of Chinese
Changsha, Hunan, China
China, Jiangsu
SuqianMaternal and Child Health Hospital
Suqian, Jiangsu, China
China, Jiangxi
First Hospital, Jiangxi college of Chinese Medicine
Nanchang, Jiangxi, China
China, Liaoning
Dalian Maternal and Child Health Hospital
Dalian, Liaoning, China
China, Shanxi
Shanxi Hospital of Chinese Medicine
Taiyuan, Shanxi, China
China, Tianjin
First Affiliated Hospital of Tianjin University of Chinese Medicine
Tianjin, Tianjin, China
Second Affiliated Hospital, Tianjin University of Chinese Medicine
Tianjin, Tianjin, China
China, Zhejiang
Zhejiang province hospital of integrated traditional and western medicine
Hangzhou, Zhejiang, China
China
Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, China
Sponsors and Collaborators
Heilongjiang University of Chinese Medicine
Ministry of Science and Technology of the People´s Republic of China
Investigators
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
  More Information

Responsible Party: Xiaoke Wu, Professor and Department Chairman of Obstetrics and Gynecology, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT01116167     History of Changes
Other Study ID Numbers: you070316 
Study First Received: April 27, 2010
Last Updated: May 17, 2013
Health Authority: China: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Heilongjiang University of Chinese Medicine:
Polycystic Ovary Syndrome

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
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

ClinicalTrials.gov processed this record on December 02, 2016