CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 42 enrolled
Drug / intervention
Tamoxifen +1 moredrug
Likely dose
Tamoxifen 10 mg orally twice daily for 7 days starting on day 21 after IUD insertionAI-extracted
Key inclusion· 2
  • Initiating use of 52 mg levonorgestrel-releasing IUD for contraceptive purposes
  • Access to reliable cell phone and willing to respond to daily text or email messages about bleeding
Key exclusion· 10
  • Using IUD for indication other than contraception
  • Postpartum within 6 months, pregnant, or breastfeeding
  • Undiagnosed abnormal uterine bleeding prior to IUD placement
  • Bleeding dyscrasia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02824224
NCT02824224Phase 4Completed

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

Oregon Health and Science University·interventional·Posted Jul 6, 2016·Updated Jun 4, 2019

In Brief

A Phase 4 clinical trial evaluating Tamoxifen and Placebo (for Tamoxifen) for Menorrhagia and 2 related conditions. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 6, 2016
Enrollment StartSep 6, 2016
Primary CompletionJan 8, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.0 years ago

Interventions

Tamoxifendrug

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

Placebo (for Tamoxifen)drug

Sugar pill manufactured to mimic the tamoxifen 10mg tablet