Clinical trial NCT04941833: Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo
Official title: The Use of Oral Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo : A Randomized Controlled Trial Evaluation of the Effect on Cyst Diameter and Associated Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Endometrioma
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2021-06-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cyst diameter
timeFrame: 3 months after drug given
Secondary outcomes:
measure: Associated pain
timeFrame: 3 months after drug given
Other outcomes:
measure: Effect of the drug in the study
timeFrame: 3 months after drug given
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Ratchadaporn Roekyindee, MD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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. doi: 10.1016/j.ejogrb.2006.08.002. Epub 2006 Sep 11.