NCT02824224

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

New users of the LNG IUD will be eligible. Subjects will be randomized to receive tamoxifen 10 mg twice daily for 7 days or placebo. Study drug will be started 3 weeks after placement of the IUD. Subjects will maintain a record of daily bleeding and spotting using an electronic text messaging diary.

Conditions

• Menorrhagia
• Metrorrhagia
• Medicated Intrauterine Devices

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-09-06
• Primary completion: 2018-01-08
• Completion: 2018-01-08
• First posted: 2016-07-06
• Last updated: 2019-06-04
• Results posted: 2019-05-21

Locations

1 site across 1 country: United States