Completed PHASE3 INTERVENTIONAL 2-arm NCT01695902

Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding (LVS-20)

A Multiple Center, Randomised, Parallel Group, Single-blind Clinical Trial, to Assess the Therapeutic Equivalence in Terms of Efficacy and Safety of Test Product (Levosert) and Reference Product (Mirena®) in Patients With Menorrhagia - Phase III (Therapeutic Equivalence).

Sponsor: Uteron Pharma S.A.

Conditions Heavy Menstrual Bleeding

Interventions Levosert-20 Mirena

Updated 4 times since 2017 Last updated: Sep 27, 2012 Started: Dec 31, 2007 Primary completion: Jan 31, 2010 Completion: Sep 30, 2011

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01695902, this PHASE3 trial focuses on Heavy Menstrual Bleeding and remains completed. Sponsored by Uteron Pharma S.A., it has been updated 4 times since 2007, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

4 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jan 2017 — Jan 2021 [monthly]

Completed PHASE3

First recorded

Dec 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Uteron Pharma S.A.

Data source: Uteron Pharma S.A.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.