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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04941833
Other study ID # 147/2564
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date June 1, 2021
Est. completion date September 30, 2022

Study information

Verified date October 2022
Source Rajavithi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Use of the oral desogestrel compared with placebo for preoperative treatment of endometrioma in the patient who underwent to surgery in next 3 months The result will be evaluated on cyst diameter, the associated pain and side effect of the oral desogestrel.


Description:

Use of the oral desogestrel compared with placebo for preoperative treatment of endometrioma in the patient who underwent to surgery in next 3 months in Rajvithi hospital Patient will randomized in 2 group : Desogestrel and placebo After 1 months and 3 months the patient have to come to hospital to evaluate the result of study The result will be evaluated on cyst diameter, the associated pain and side effect of the oral desogestrel.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 30, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 49 Years
Eligibility Inclusion Criteria: - Thai female and foreigner who can understand Thai language - Age 15-49 years - Diagnose as endometrioma sized more than 3 cm - Underwent to surgery in next 13 weeks Exclusion Criteria: - History of endometriosis - Pregnancy woman - Contraindication for desogestrel : History of thrombotic event, Autoimmune disease,gestational trophoblastic disease - Ovarian endometrioma with complications : Ruptured, twisted - Contraindications for NSAIDs : Peptic ulcer, thrombocytopenia, liver disease - History of hormonal treatment for endometrioma : DMPA,OCP, GNRH agonist/antoginist

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Desogestrel Oral Tablet
Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel

Locations

Country Name City State
Thailand Rajavithi Hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

Cucinella G, Granese R, Calagna G, Svelato A, Saitta S, Tonni G, De Franciscis P, Colacurci N, Perino A. Oral contraceptives in the prevention of endometrioma recurrence: does the different progestins used make a difference? Arch Gynecol Obstet. 2013 Oct;288(4):821-7. doi: 10.1007/s00404-013-2841-9. Epub 2013 Apr 12. — View Citation

Muzii L, Galati G, Di Tucci C, Di Feliciantonio M, Perniola G, Di Donato V, Benedetti Panici P, Vignali M. Medical treatment of ovarian endometriomas: a prospective evaluation of the effect of dienogest on ovarian reserve, cyst diameter, and associated pain. Gynecol Endocrinol. 2020 Jan;36(1):81-83. doi: 10.1080/09513590.2019.1640199. Epub 2019 Jul 14. — View Citation

Razzi S, Luisi S, Ferretti C, Calonaci F, Gabbanini M, Mazzini M, Petraglia F. Use of a progestogen only preparation containing desogestrel in the treatment of recurrent pelvic pain after conservative surgery for endometriosis. Eur J Obstet Gynecol Reprod Biol. 2007 Dec;135(2):188-90. Epub 2006 Sep 11. — View Citation

Taniguchi F, Enatsu A, Ota I, Toda T, Arata K, Harada T. Effects of low dose oral contraceptive pill containing drospirenone/ethinylestradiol in patients with endometrioma. Eur J Obstet Gynecol Reprod Biol. 2015 Aug;191:116-20. doi: 10.1016/j.ejogrb.2015.06.006. Epub 2015 Jun 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Effect of the drug in the study Effect of the oral desogestrel and placebo such as spotting, weight gain, wood swing 3 months after drug given
Primary Cyst diameter Cyst diameter is calculated by transvaginal ultrasound with calculated in the diameter of endometrimas (cm) 3 months after drug given
Secondary Associated pain Associated pain is measured by the visual analog score. The patients will record the score on the book everytimes when they have pain 3 months after drug given
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