Postoperative Desogestrel for Endometriosis Related Pain

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT01559480

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: Desogestrel Drug: Placebo	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Desogestrel	Drug: Desogestrel Desogestrel 75 mcg Takes 1 capsule before bedtime for 6 months Other Names: Cerazette
Placebo Comparator: Placebo	Drug: Placebo Placebo capsule takes 1 capsule before bedtime for 6 months

Arm

Intervention/Treatment

Active Comparator: Desogestrel

Drug: Desogestrel

Desogestrel 75 mcg Takes 1 capsule before bedtime for 6 months

Other Names:

Cerazette

Placebo Comparator: Placebo

Drug: Placebo

Placebo capsule takes 1 capsule before bedtime for 6 months

Outcome Measures

Primary Outcome Measures

Pain score [6 months]
Pain score will be assessed by visual analog scale (0-10)

Secondary Outcome Measures

Side effect compared between both group [6 month]
Patients satisfaction compare between both groups [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine Siriraj hospital, Mahidol university	Bangkok noi	Bangkok	Thailand	10700
2	Siriraj hospital Mahidol university	Bangkok noi	Bangkok	Thailand	10700