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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device. 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.

Detailed Summary: New users of the LNG IUS will be eligible. Subjects will be randomized to receive tamoxifen 10 mg BID for 7 days or placebo. Study drug will be started 3 weeks after placement of the IUS. Subjects will maintain a record of daily bleeding and spotting using an electronic text messaging diary.
Sponsor: Oregon Health and Science University

Current Primary Outcome: Reduction in bleeding and spotting days [ Time Frame: 30 days after initiation of study drug ]

Mean number of bleeding and spotting days in the tamoxifen group compared to the mean number of bleeding and spotting days in the placebo group


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bleeding pattern satisfaction [ Time Frame: 60 days after initiation of study drug ]
    0-100 mm visual analog scale measurement of satisfaction with bleeding pattern
  • IUD satisfaction [ Time Frame: 60 days after initiation of study drug ]
    0-100 mm visual analog scale measurement of satisfaction with IUS
  • Adverse events [ Time Frame: 60 days after initiation of study drug ]
    Descriptive reporting of adverse events for each arm


Original Secondary Outcome: Same as current

Information By: Oregon Health and Science University

Dates:
Date Received: July 2, 2016
Date Started: September 2016
Date Completion: December 2017
Last Updated: February 3, 2017
Last Verified: February 2017