Postoperative Desogestrel for Endometriosis Related Pain

Endometriosis Clinical Trial

Official title:

A Prospective Double Blind Randomized Controlled Trial to Study the Effectiveness of a Desogestrel for the Treatment of Pelvic Pain or Dysmenorrhea in the Patients Undergone Conservative Surgery for Pelvic Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559480
• Other study ID #: R015532018
• Status: Completed
• Phase: N/A
• First received: March 12, 2012
• Last updated: April 8, 2015
• Start date: January 2012
• Est. completion date: October 2014

Study information

• Verified date: April 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Endometriosis is one of the most common disease in reproductive aged women.Surgical intervention has a significant symptoms relief. However, symptom recurrence is often after surgery. This study aims to determine the efficacy of Desogestrel compared with placebo in pain symptom of symptomatic endometriosis patient undergo conservative surgery . The primary outcome measurement is pain score at 6 months after surgery.

Description:

After conservative surgery, the patients are randomized to Desogestrel and placebo groups. VAS pain score are compared after complete 6 months

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• diagnoses endometriosis

• Plan conservative surgery

• initial pain score at least 5

• voluntary to be the participant of this study with inform consent

• No desired child bearing in 6 months

Exclusion Criteria:

• residual lesion after surgery which required further treatment

• cannot participate complete 6 months after surgery

• contraindication for Desogestrel, Paracetamol or Ponstan

• Pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Desogestrel
Desogestrel 75 mcg Takes 1 capsule before bedtime for 6 months
• Placebo
Placebo capsule takes 1 capsule before bedtime for 6 months

Locations

Country	Name	City	State
Thailand	Faculty of medicine Siriraj hospital, Mahidol university	Bangkok noi	Bangkok
Thailand	Siriraj hospital Mahidol university	Bangkok noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Pain score will be assessed by visual analog scale (0-10)	6 months	Yes
Secondary	Side effect compared between both group		6 month	Yes
Secondary	Patients satisfaction compare between both groups		6 months	Yes