Status:
UNKNOWN
A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of PCOS
Lead Sponsor:
Aijun Sun
Collaborating Sponsors:
First Affiliated Hospital, Sun Yat-Sen University
Tang-Du Hospital
Conditions:
PCOS
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief Summary
This study evaluates the effects and biological mechanisms of Dingkundan，Diane-35 and the combination of Dingkundan and Diane-35 in the treatment of polycystic syndrome(PCOS) in adults women. One thir...
Detailed Description
Dingkundan,Diane-35 each ameliorate PCOS, but they do so by different mechanisms. We generally treat PCOS patients without immediate fertility requirement by short-acting contraceptives,Diane-35 is on...
Eligibility Criteria
Inclusion
- Subject is a female between the age of 18 and 40.
- Subject diagnosed as PCOS by the 2003 Rotterdam criteria.
- Subject provides written informed consent.
Exclusion
- Subject has other endocrine diseases,such as adrenal hyperplasias or tumor, androgen-secreting tumours, Cushing's syndrome,thyroid diseases and hyperprolactinemia.
- Subject has received related medical or surgical treatment in the past 3 months.
- Subject suffered from substance abuse or dependence(such as alcohol or drugs);
- Subject is a heavy smoker(reaching or more than 20 cigarettes a day).
- Subject is pregnant or lactating or within 1 year after delivery.
- Subject has a severe systemic disease, such as cardiovascular system
- Subject has a history of malignancy or radiotherapy.
- Subject has an allergic history to the drugs used in the study.
- Subject has mental disorder incapable of elementary cooperations.
- Subject has participated in other clinical researches of medicine within 3 month prior to randomization.
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2018
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT03264638
Start Date
October 1 2016
End Date
August 31 2018
Last Update
February 5 2018
Active Locations (1)
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1
Lei Li
Beijing, China/Beiing, China, 100000