Last reviewed · How we verify

NCT02793908: PleyrisEndom

The Role of the Subcutaneous Progesterone in Luteal Phase Supplementation in Patients With Endometriosis

Status unknown Phase 3 Last updated 17 November 2016
What this trial tests

Phase 3 trial testing Pleyris in Endometriosis in 52 participants. Status unknown.

Timeline
1 June 2016
Primary endpoint
1 June 2017
1 August 2017

Quick facts

Lead sponsorUniversity Magna Graecia
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment52
Start date1 June 2016
Primary completion1 June 2017
Estimated completion1 August 2017
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University Magna Graecia

Who can join

Adults 18 to 38, female only, with Endometriosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The aim of the study protocol will be to compare the efficacy of subcutaneous progesterone (25 mg / day; Pleyris, IBSA Institut Biochimique SA) with vaginal progesterone (90 mg / day; Crinone, Merck Serono) administered during the luteal phase in term of pelvic pain reduction in patients with grade I-II endometriosis and / or endometrioma \<4 cm subjected to time intercourses or COS/IUI cycles.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Progesterone receptor ligands for the treatment of endometriosis: the mechanisms behind therapeutic success and failure.
    Reis FM, Coutinho LM, Vannuccini S, Batteux F, et al · · 2020 · cited 88× · PMID 32412587 · DOI 10.1093/humupd/dmaa009

Verify or expand the search:

Other recruiting trials for Endometriosis

Currently open trials in the same condition.

Other University Magna Graecia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02793908.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing