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Clinical Trials/ISRCTN97865475
ISRCTN97865475
Completed
Phase 4

PRE-EMPT: Preventing Recurrence of Endometriosis by Means of long acting Progestogen Therapy

HS Grampian (UK)0 sites403 target enrollmentMarch 20, 2014
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
HS Grampian (UK)
Enrollment
403
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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)

Registry
who.int
Start Date
March 20, 2014
End Date
June 30, 2021
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Sponsor
HS Grampian (UK)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

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