Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo

October 27, 2022 updated by: Rajavithi Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Cerazette
Experimental: Desogestrel group
Drug: Desogestrel Oral Tablet
Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel
Other Names:
  • Cerazette

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cyst diameter
Time Frame: 3 months after drug given
Cyst diameter is calculated by transvaginal ultrasound with calculated in the diameter of endometrimas (cm)
3 months after drug given

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after drug given

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after drug given

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajavithi Hospital

Investigators

  • Study Director: Ratchadaporn Roekyindee, MD, Rajavithi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 18, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 27, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 147/2564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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