Preventing recurrence of endometriosis by means of long acting protestogen therapy

Phase 4

Completed

• Conditions: Topic: Reproductive Health; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth; Urological and Genital Diseases; Endometriosis

• Registration Number: ISRCTN97865475
• Lead Sponsor: HS Grampian (UK)

Brief Summary

2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/28283026 Internal pilot focus group results 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38749550/ (added 21/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-20
• Study Completion: 2021-06-30
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 403

Inclusion Criteria

1. Women aged 16-45
2. No immediate plans to conceive
3. 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 COCP

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified