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Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)

NCT02824224 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-06-04

Study results available
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Summary

This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device (IUD). Half of participants will receive a course of tamoxifen three weeks after insertion of the IUD, while the other half of participants will receive a course of placebo.

Conditions

  • Menorrhagia
  • Metrorrhagia
  • Medicated Intrauterine Devices

Interventions

DRUG

Tamoxifen

10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

DRUG

Placebo (for Tamoxifen)

Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Megan A Cohen, MD, MPH · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-06
Primary Completion
2018-01-08
Completion
2018-01-08

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 NCT02824224 on ClinicalTrials.gov