✓ Translated by DotMD AI Clinical Council Source: Obstetrics and gynecology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #37023451 ↗

Phase III Randomized Trial: Levonorgestrel 52-mg Intrauterine Device Efficacy and Safety After More Than 8 Years of Use

Original Paper Title: “Levonorgestrel 52-mg Intrauterine Device Efficacy and Safety After More Than 8 Years of Use”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • The Sponsor, Medicines360, designed the study and oversaw its conduct, including funding the trial and providing all study product free of charge to participants. ClinicalTrials.gov, NCT00995150.
  • Study Design & Sample: Phase III Randomized Trial published in Obstetrics and gynecology (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Obstetrics and gynecology (2023), this phase iii randomized trial evaluating human clinical outcomes investigated: Medicines360. Key clinical takeaway: The Sponsor, Medicines360, designed the study and oversaw its conduct, including funding the trial and providing all study product free of charge to participants. ClinicalTrials.gov, NCT00995150.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Obstetrics and gynecology, 2023-05-01; Phase III Randomized Trial; Rigor 82/100): The Sponsor, Medicines360, designed the study and oversaw its conduct, including funding the trial and providing all study product free of charge to participants. ClinicalTrials.gov, NCT00995150.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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