Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Desogestrel group Desogestrel group |
Drug: Desogestrel Oral Tablet
Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel
Other Names:
|
| Placebo Comparator: Control group Placebo |
Drug: Desogestrel Oral Tablet
Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cyst diameter [3 months after drug given]
Cyst diameter is calculated by transvaginal ultrasound with calculated in the diameter of endometrimas (cm)
Secondary Outcome Measures
- Associated pain [3 months after drug given]
Associated pain is measured by the visual analog score. The patients will record the score on the book everytimes when they have pain
Other Outcome Measures
- Effect of the drug in the study [3 months after drug given]
Effect of the oral desogestrel and placebo such as spotting, weight gain, wood swing
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rajavithi Hospital | Bangkok | Thailand | 10400 |
Sponsors and Collaborators
- Rajavithi Hospital
Investigators
- Study Director: Ratchadaporn Roekyindee, MD, Rajavithi Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Postoperative desogestrel for pelvic endometriosis-related pain: a randomized controlled trial
- Long-Term Administration of Dienogest Reduces Recurrence after Excision of Endometrioma
Publications
- 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.
- 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.
- 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.
- 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.
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