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出境医 / 临床实验 / Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo

Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo

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
Endometrioma Drug: Desogestrel Oral Tablet 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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022
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 Name: Cerazette
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 Name: Cerazette
Outcome Measures
Primary Outcome Measures :
  1. Cyst diameter [ Time Frame: 3 months after drug given ]
    Cyst diameter is calculated by transvaginal ultrasound with calculated in the diameter of endometrimas (cm)


Secondary Outcome Measures :
  1. Associated pain [ Time Frame: 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:
  1. Effect of the drug in the study [ Time Frame: 3 months after drug given ]
    Effect of the oral desogestrel and placebo such as spotting, weight gain, wood swing


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Contacts
Layout table for location contacts
Contact: Atitaya Sakunthai, MD 0896224462 A.sakunthai@gmail.com

Locations
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Thailand
Rajavithi Hospital Recruiting
Bangkok, Thailand, 10400
Contact: Ratchadaporn Roekyindee, Subspecialty    081-5766202    Ratchadaporn@gmail.com   
Principal Investigator: Atitaya Sakunthai, MD         
Sponsors and Collaborators
Rajavithi Hospital
Investigators
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Study Director: Ratchadaporn Roekyindee, MD Rajavithi Hospital
Tracking Information
First Submitted Date  ICMJE June 18, 2021
First Posted Date  ICMJE June 28, 2021
Last Update Posted Date June 28, 2021
Actual Study Start Date  ICMJE June 1, 2021
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2021) 		Cyst diameter [ Time Frame: 3 months after drug given ]
Cyst diameter is calculated by transvaginal ultrasound with calculated in the diameter of endometrimas (cm)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2021) 		Associated pain [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 18, 2021) 		Effect of the drug in the study [ Time Frame: 3 months after drug given ]
Effect of the oral desogestrel and placebo such as spotting, weight gain, wood swing
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Endometrioma
Intervention  ICMJE Drug: Desogestrel Oral Tablet
Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel
Other Name: Cerazette
Study Arms  ICMJE
  • Experimental: Desogestrel group
    Desogestrel group
    Intervention: Drug: Desogestrel Oral Tablet
  • Placebo Comparator: Control group
    Placebo
    Intervention: Drug: Desogestrel Oral Tablet
Publications *
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2021) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 49 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Atitaya Sakunthai, MD 0896224462 A.sakunthai@gmail.com
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04941833
Other Study ID Numbers  ICMJE 147/2564
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rajavithi Hospital
Study Sponsor  ICMJE Rajavithi Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ratchadaporn Roekyindee, MD Rajavithi Hospital
PRS Account Rajavithi Hospital
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP