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Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding

NCT03642210 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-05-14

Study results available
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Summary

To assess the efficacy of a levonorgestrel 52 mg intrauterine system as a treatment for heavy menstrual bleeding.

Conditions

  • Menorrhagia

Interventions

COMBINATION_PRODUCT

Levonorgestrel 52 mg intrauterine system

Levonorgestrel 52 mg intrauterine system

Sponsors & Collaborators

  • Medicines360

    lead OTHER

Principal Investigators

  • Andrea Olariu, MD, PhD · COO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-17
Primary Completion
2021-10-12
Completion
2021-10-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03642210 on ClinicalTrials.gov