Clinical Trials Directory

Trials / Completed

CompletedNCT03586063

Study of Diphereline 3.75 mg Treatment In Women Suffering From Internal Genital Endometriosis

A Multicenter Observational Study of Diphereline 3.75 mg Treatment Effectiveness in Russian Women Suffering From Internal Genital Endometriosis

Status
Completed
Phase
Study type
Observational
Enrollment
465 (actual)
Sponsor
Ipsen · Industry
Sex
Female
Age
25 Years – 40 Years
Healthy volunteers
Not accepted

Summary

To describe Gonadotropin-Releasing Hormone agonists (GnRH-a) treatment effectiveness on reduction of internal genital endometriosis symptom - menorrhagia - in different disease stages I, II, III in the Russian patient population scheduled for treatment with Diphereline 3,75 mg - assessment performed six months after the last injection.

Conditions

Interventions

TypeNameDescription
OTHERData collectionThis is a non-interventional (observational) national multicentre prospective study. Treatment was administered according to the Summary of Product Characteristics (SmPC): maximum 6 injections administered every 28 days. The decision to prescribe GnRH-a (Diphereline 3,75 mg) was made prior to and independently from the decision to enroll the patient into the study.

Timeline

Start date
2011-11-03
Primary completion
2014-12-24
Completion
2014-12-24
First posted
2018-07-13
Last updated
2018-07-13

Locations

34 sites across 1 country: Russia

Source: ClinicalTrials.gov record NCT03586063. Inclusion in this directory is not an endorsement.