Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine
This study is currently recruiting participants.
Verified May 2013 by Heilongjiang University of Chinese Medicine
Sponsor:
Heilongjiang University of Chinese Medicine
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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):
- Oligo- or anovulation
- Clinical and/or biochemical signs of hyperandrogenism
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116167
Contacts
| Contact: Yan Li, MD.PhD. | liyantcm@163.com |
Locations
| China, Anhui | |
| Affiliated Hospital of Anhui University of Chinese Medicine | Active, not recruiting |
| Hefei, Anhui, China | |
| China, Guangdong | |
| Guangzhou Medical School First Affiliated Hospital | Recruiting |
| Guangzhou, Guangdong, China | |
| Principal Investigator: Hongxia Ma, MD | |
| Affiliated Hospital of Guangzhou Medical University | Active, not recruiting |
| Guangzhou, Guangdong, China | |
| China, Heilongjiang | |
| Daqing Longnan hospital | Active, not recruiting |
| Daqing, Heilongjiang, China | |
| Daqing LongNa Hospital | Active, not recruiting |
| Daqing, Heilongjiang, China, 163000 | |
| First Affliated Hospital of Harbin Medical University | Active, not recruiting |
| Harbin, Heilongjiang, China | |
| Obstetrics and Gynecology,Heilongjiang University of Chinese Medicine | Recruiting |
| Harbin, Heilongjiang, China, 150040 | |
| Contact: Xiaoke Wu, MD.PhD. 86-451-8213 0094 xiaokewu2002@vip.sina.com | |
| Contact: Lihui Hou, MD. 86-451-8213 0094 houlihui2007@sina.com | |
| Principal Investigator: Lihui Hou, MD. | |
| Principal Investigator: Xiaoke Wu, MD.PhD. | |
| Mudanjiang maternal and children hospital | Active, not recruiting |
| Mudanjiang, Heilongjiang, China | |
| China, Henan | |
| 2nd Affiliated Hospital of Henan University of Chinese Medicine | Active, not recruiting |
| Zhengzhou, Henan, China | |
| China, Hunan | |
| First Affiliated Hospital of Hunan University of Chinese | Active, not recruiting |
| Changsha, Hunan, China | |
| China, Jiangsu | |
| SuqianMaternal and Child Health Hospital | Active, not recruiting |
| Suqian, Jiangsu, China | |
| China, Jiangxi | |
| First Hospital, Jiangxi college of Chinese Medicine | Active, not recruiting |
| Nanchang, Jiangxi, China | |
| China, Liaoning | |
| Dalian Maternal and Child Health Hospital | Active, not recruiting |
| Dalian, Liaoning, China | |
| China, Shanxi | |
| Shanxi Hospital of Chinese Medicine | Active, not recruiting |
| Taiyuan, Shanxi, China | |
| China, Tianjin | |
| First Affiliated Hospital of Tianjin University of Chinese Medicine | Active, not recruiting |
| Tianjin, Tianjin, China | |
| Second Affiliated Hospital, Tianjin University of Chinese Medicine | Active, not recruiting |
| Tianjin, Tianjin, China | |
| China, Zhejiang | |
| Zhejiang province hospital of integrated traditional and western medicine | Active, not recruiting |
| Hangzhou, Zhejiang, China | |
| China | |
| Second Affiliated Hospital of Heilongjiang University of Chinese Medicine | Active, not recruiting |
| 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
No publications provided
| 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:
|
Polycystic Ovary Syndrome Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders |
Endocrine System Diseases Letrozole Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013