Skip to main content
OpenTrials
Completed

NCT Number: NCT04941833

Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometrioma Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Rajavithi Hospital

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desogestrel Oral Tablet

Drug

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

Other names: Cerazette

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2021
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.