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Clinical Trials/EUCTR2013-001984-21-GB
EUCTR2013-001984-21-GB
Active, not recruiting
Not Applicable

PRE-EMPT: Preventing Recurrence of Endometriosis by Means of long acting Protestogen Therapy - PRE-EMPT v1.0

niversity of Aberdeen & NHS Grampian0 sitesAugust 1, 2013
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ConditionsEndometriosisMedDRA version: 14.1Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsMirena®Depo-ProveraMicrogynon -30

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometriosis
Sponsor
niversity of Aberdeen & NHS Grampian
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 1, 2013
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
niversity of Aberdeen & NHS Grampian

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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