Completed PHASE4 INTERVENTIONAL 3-arm NCT01295294

Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)

International, Prospective, Double-blind, 3-arm Comparative, Randomized, Placebo-controlled Phase IV Study on the Effect of Counseling and Either Tranexamic Acid or Mefenamic Acid or Placebo, on the Management of Bleeding/Spotting in Women Using the Levonorgestrel-releasing Intrauterine System (MIRENA) for Contraception.

Sponsor: Bayer

Conditions Uterine Hemorrhage

Interventions Mefenamic acid Mirena (Levonorgestrel IUS, BAY86-5028) Placebo Tranexamic acid

Updated 6 times since 2017 Last updated: Nov 2, 2014 Started: Mar 31, 2011 Primary completion: Dec 31, 2011 Completion: Dec 31, 2011

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

Listed as NCT01295294, this PHASE4 trial focuses on Uterine Hemorrhage and remains completed. Sponsored by Bayer, it has been updated 6 times since 2011, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE4
Sep 2024 — Sep 2025 [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
Jan 2021 — Jul 2024 [monthly]

Completed PHASE4
Jun 2018 — Jan 2021 [monthly]

Completed PHASE4

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE4

First recorded

Mar 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bayer

Data source: Bayer

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

Study Locations

Aalborg, Denmark , Blackrock, Ireland , Cork, Ireland , Elverum, Norway , Haugesund, Norway , København NV, Denmark , Mallow, Ireland , Odense C, Denmark , Skive, Denmark , Søborg, Denmark and 2 more locations