Preventing Recurrence of Endometriosis by means of long acting Protestogen Therapy

• Conditions: Endometriosis; MedDRA version: 14.1Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2013-001984-21-GB
• Lead Sponsor: niversity of Aberdeen & NHS Grampian

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-01
• Last Update Posted: 4 November 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Investigators will be asked to confirm each eligibility criteria at randomisation. Inclusion Criteria: To be eligible for the PREEMPT Trial: • Women aged 16-45 • No immediate plans to conceive • Are scheduled to have laparoscopic conservative surgery, or a diagnostic laparoscopy with concurrent surgery if endometriosis is found, for pelvic pain associated with endometriosis. • (Pilot phase) willing to be randomised to at least one long acting progestogen (LNG-IUS/ DMPA) and either COCP or no treatment
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Any women, who at the point of randomisation, have any of the following are not eligible for the trial: • Current infertility (trying for a baby, receiving or contemplating fertility treatment) • Deep infiltrating endometriosis, involving the bowel or rectovaginal septum, and requiring complex surgery, whether pre-planned or identified at laparoscopy • Contraindications to the use of hormonal treatment with oestrogen or progestogens • Suspicion of malignancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified