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Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo

Primary Purpose

Endometrioma

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Desogestrel Oral Tablet

About this trial

This is an interventional treatment trial for Endometrioma

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Desogestrel group

Control group

Arm Description

Desogestrel group

Placebo

Outcomes

Primary Outcome Measures

Cyst diameter

Cyst diameter is calculated by transvaginal ultrasound with calculated in the diameter of endometrimas (cm)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04941833

First Posted

June 18, 2021

Last Updated

October 27, 2022

Sponsor

Rajavithi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04941833

Brief Title

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

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

July 31, 2022 (Actual)

Study Completion Date

September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Desogestrel group

Arm Type

Experimental

Arm Description

Desogestrel group

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Desogestrel Oral Tablet

Other Intervention Name(s)

Cerazette

Intervention Description

Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel

Primary Outcome Measure Information:

Title

Cyst diameter

Description

Cyst diameter is calculated by transvaginal ultrasound with calculated in the diameter of endometrimas (cm)

Time Frame

3 months after drug given

Secondary Outcome Measure Information:

Title

Associated pain

Description

Associated pain is measured by the visual analog score. The patients will record the score on the book everytimes when they have pain

Time Frame

3 months after drug given

Other Pre-specified Outcome Measures:

Title

Effect of the drug in the study

Description

Effect of the oral desogestrel and placebo such as spotting, weight gain, wood swing

Time Frame

3 months after drug given

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ratchadaporn Roekyindee, MD

Organizational Affiliation

Rajavithi Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Rajavithi Hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31304853

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.

Results Reference

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PubMed Identifier

23580011

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.

Results Reference

background

PubMed Identifier

26115056

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.

Results Reference

background

PubMed Identifier

16963174

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.

Results Reference

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Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo

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