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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20140702001 |
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Date of registration:
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02/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparative Effect of Desogestrel and Combined Ethinyl Estradiol & Desogestrel on Cell Proliferation and Apoptosis of Ectopic Endometrial Tissues in Endometriosis : A Randomized Controlled Study
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Scientific title:
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Comparative Effect of Desogestrel and Combined Ethinyl Estradiol & Desogestrel on Cell Proliferation and Apoptosis of Ectopic Endometrial Tissues in Endometriosis : A Randomized Controlled Study |
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Date of first enrolment:
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07/07/2014 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20140702001 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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N/A
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Countries of recruitment
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thailand
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Contacts
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Name:
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Areepan
Sophonsritsuk |
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Address:
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1345/96 Phaholyothin Rd., Samsennai, Payathai
10400
Bangkok
Thailand |
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Telephone:
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(662)2011412 |
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Email:
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areepan.sop@mahidol.ac.th |
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Affiliation:
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none |
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Name:
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Siriluk
Tantanavipas |
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Address:
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Praram 6 Phayathai
10400
Bangkok
Thailand |
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Telephone:
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(662)2011412 |
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Email:
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Pim_ky@hotmail.com |
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Affiliation:
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Mahidol University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1 healthy women age 18 40 yrs
2 diagnose as endometrioma with more than 3 cm in
3 No history of hormonal usage within 3 months or no treatment of depot medroxyprogesterone acetate DMPA or GnRH agonist past 9 months
4 no contraindication for Ethinyl estradiol and Desogestrel
Exclusion criteria: 1) subjects with underlying disease which is not appropiate for taking combine pill, Ethinyl estradiol and Desgestrel
2) Contraindicate to Ethinyl estradiol ���Desgestrel
3) cannot tolerate to OC
4) deny to be recruited in the study
5) pathological report not endometriosis
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Patient with endometriotic cyst at least 3 cm in diameter
Endometriosis
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Endometriosis
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Intervention(s)
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None,Desogestrel 150 mg,Ethinyl estradiol (0.03 mg/tab) & Desogestrel (0.15 mg/tab) (Marvelon®)
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no treatment,Desogestrel (0.15 mg/d) (Cerazette®) prescribe 2 tab/d for 28-35 days ,1 tablet of Marvelon® compose of Ethinyl estradiol (0.03 mg/tab) & Desogestrel (0.15 mg/tab)
prescribe 1 tab/d for 28-35 days
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Active Comparator No treatment,Active Comparator Drug,Active Comparator Drug
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Primary Outcome(s)
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cell proliferation by Ki IHC, 1 month positive stained cells/100 cells,apoptosis by TUNEL assay 1 month positive stained cells/100 cells,antiapoptosis marker BCl2 1 month postive stained cells/100 cells
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Secondary Outcome(s)
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Immunohistochemistry for macrophage (CD68) 1 month cell number of positive stained CD68 ,Immunohistochemistry for NK cells (CD57) 1 month cell number of positive stained CD57
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Source(s) of Monetary Support
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Faculty of Medicine, Ramathibodi hospital
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
dircracm@mahidol.ac.th
Committee on Human rights related to research involving human subjects.
02-201-1544 Ext.
dircracm@mahidol.ac.th
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Results
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Results available:
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Date Posted:
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Date Completed:
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01/03/2016 |
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URL:
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