Postoperative Desogestrel for Endometriosis Related Pain

Mahidol University

Status: Completed

Conditions: Endometriosis

Treatments: Drug: Placebo; Drug: Desogestrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01559480

R015532018

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Desogestrel

Active Comparator group

Treatment:

Drug: Desogestrel

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo