Letrozole Versus Chinese Herbal Compound on Polycystic Ovary Syndrome (PCOS)
This study is currently recruiting participants.
Verified September 2012 by Heilongjiang University of Chinese Medicine
Sponsor:
Xiaoke Wu
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01431352
First received: September 6, 2011
Last updated: September 19, 2012
Last verified: September 2012
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Purpose
Polycystic ovary syndrome (PCOS) is a heterogeneous disorder affecting almost 4%-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. The purpose of this study is to determine whether Letrozole alone or combined with Chinese herbal compound are effective in the treatment of PCOS patients.
| Condition | Intervention |
|---|---|
|
Polycystic Ovary Syndrome |
Drug: Letrozole Drug: Chinese herbal compound Drug: Chinese herbal compound placebo |
| 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: | Polycystic Ovary Syndrome- Effect of Letrozole and Chinese Herbal Compound |
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:
- Pregnancy rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Ovulation rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | September 2011 |
| 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+ Chinese herbal compound |
Drug: 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.
Drug: Chinese herbal compound
2 package daily for 6 month
|
| Placebo Comparator: Letrozole+ placebo |
Drug: Chinese herbal compound placebo
2 packages daily for 6 month
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of Polycystic ovary syndrome (using 2003 Rotterdam criteria)
- WIth desire for children
Exclusion Criteria:
- Tubal or male factor infertility or sub-fertility
- Suspected peritoneal factor infertility
- Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431352
Contacts
| Contact: Lihui Hou, MD | 86-451-82130094 | houlihui2007@hotmail.com |
| Contact: Xiaoke Wu, MD. PhD | 86-451-82130094 | xiaokewu2002@vip.sina.com |
Locations
| China, Anhui | |
| Affiliated Hospital of Anhui University of Chinese Medicine | Active, not recruiting |
| Hefei, Anhui, China | |
| China, Daqing | |
| Daqing Longnan hospital | Active, not recruiting |
| Daqing, Daqing, China | |
| China, Guangdong | |
| Guangzhou Medical School First Affiliated Hospital | Active, not recruiting |
| Guangzhou, Guangdong, China | |
| China, Heilongjiang | |
| Daqing Oilfield General Hospital | Active, not recruiting |
| Daqing, Heilongjiang, China | |
| First Affliated Hospital of Harbin Medical University | Recruiting |
| Harbin, Heilongjiang, China, 150001 | |
| Contact: Muer An, MD | |
| Principal Investigator: Muer An, MD | |
| Dept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese Medicine | Recruiting |
| Herbin, Heilongjiang, China, 150040 | |
| Contact: Lihui Hou , MD. 86-451-82130094 | |
| Principal Investigator: Lihui Hou, MD. | |
| 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 | |
| Maternal and Child Health Hospital of Xuzhou | Active, not recruiting |
| Xuzhou, 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 | Recruiting |
| Dalian, Liaoning, China | |
| Principal Investigator: Xiaoguang Shao, MD | |
| China, Shanxi | |
| Shanxi Hospital of Chinese Medicine | Active, not recruiting |
| Taiyuan, Shanxi, China | |
| China, Tianjin | |
| Second Affiliated Hospital, Tianjin University of Chinese Medicine | Active, not recruiting |
| Tianjin, Tianjin, China | |
| First Affiliated Hospital of Tianjin University of Chinese Medicine | Active, not recruiting |
| Tianjin, Tianjin, China | |
| China, Zhejiang | |
| Zhejiang province hospital of integrated traditional and western medicine | Recruiting |
| Hangzhou, Zhejiang, China | |
| Contact: Xin Sun, MD | |
| Principal Investigator: Xin Sun, MD | |
| China | |
| Second Affiliated Hospital of Heilongjiang University of Chinese Medicine | Active, not recruiting |
| Harbin, China | |
Sponsors and Collaborators
Xiaoke Wu
More Information
No publications provided
| Responsible Party: | Xiaoke Wu, Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital, Heilongjiang University of Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT01431352 History of Changes |
| Other Study ID Numbers: | Letrozole |
| Study First Received: | September 6, 2011 |
| Last Updated: | September 19, 2012 |
| Health Authority: | China: Ministry of Science and Technology |
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 June 17, 2013