NCT04941833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

June 18, 2021

Last Update Submit

October 27, 2022

Conditions

Endometrioma

Outcome Measures

Primary Outcomes (1)

  • Cyst diameter

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

    3 months after drug given

Secondary Outcomes (1)

  • Associated pain

    3 months after drug given

Other Outcomes (1)

  • Effect of the drug in the study

    3 months after drug given

Study Arms (2)

Desogestrel group

EXPERIMENTAL

Desogestrel group

Drug: Desogestrel Oral Tablet

Control group

PLACEBO COMPARATOR

Placebo

Drug: Desogestrel Oral Tablet

Interventions

Desogestrel Oral TabletDRUG

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

Also known as: Cerazette
Control groupDesogestrel group

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 31304853BACKGROUND

  • 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.

    PMID: 23580011BACKGROUND

  • 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.

    PMID: 26115056BACKGROUND

  • 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.

    PMID: 16963174BACKGROUND

MeSH Terms

Conditions

Endometriosis

Interventions

Desogestrel

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

NorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Ratchadaporn Roekyindee, MD

    Department of Medical Services Ministry of Public Health of Thailand

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2021

First Posted

June 28, 2021

Study Start

June 1, 2021

Primary Completion

July 31, 2022

Study Completion

September 30, 2022

Last Updated

October 31, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)