Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo

Endometrioma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941833
• Other study ID #: 147/2564
• Status: Completed
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis

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

External Links

•   Long-Term Administration of Dienogest Reduces Recurrence after Excision of Endometrioma
•   Postoperative desogestrel for pelvic endometriosis-related pain: a randomized controlled trial