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Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo

R

Rajavithi Hospital

Status and phase

Completed
Phase 3
Phase 2

Conditions

Endometrioma

Treatments

Drug: Desogestrel Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT04941833
147/2564

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Female

Ages

15 to 49 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

20 participants in 2 patient groups, including a placebo group

Desogestrel group
Experimental group
Description:
Desogestrel group
Treatment:
Drug: Desogestrel Oral Tablet
Control group
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Desogestrel Oral Tablet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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