Endometriosis
Conditions
Keywords
Endometriosis, Desogestrel, Placebo
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.
Detailed description
After conservative surgery, the patients are randomized to Desogestrel and placebo groups. VAS pain score are compared after complete 6 months
Interventions
DRUGDesogestrel
Desogestrel 75 mcg Takes 1 capsule before bedtime for 6 months
DRUGPlacebo
Placebo capsule takes 1 capsule before bedtime for 6 months
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 6 months | Pain score will be assessed by visual analog scale (0-10) |
Secondary
| Measure | Time frame |
|---|---|
| Side effect compared between both group | 6 month |
| Patients satisfaction compare between both groups | 6 months |
Countries
Thailand
Outcome results
None listed