Phase 4 N=37 Randomized Double-blind Prevention

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

Menorrhagia · Metrorrhagia · Medicated Intrauterine Devices

Bottom Line

View on ClinicalTrials.gov: NCT02824224 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Number of Bleeding and Spotting Days — 16.8; 12.0 days

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tamoxifen (Drug); Placebo (for Tamoxifen) (Drug)
Age: Pediatric, Adult · 15+ yrs
Sex: Female
Sponsor: Oregon Health and Science University
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Bleeding and Spotting Days	16.8; 12.0	—
SECONDARY Bleeding Pattern Satisfaction	50.7; 58.6	—
SECONDARY IUD Satisfaction	82.7; 75.3	—
SECONDARY Adverse Events	12; 15	—

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.

Eligibility Criteria

Inclusion Criteria

initiating use of 52mg levonorgestrel-releasing IUD for contraceptive purposes
access to reliable cell phone
willing to receive and respond to daily text or email message to assess bleeding

Exclusion Criteria

using IUD for indication other than contraception
postpartum within 6 months, pregnant, or breastfeeding
removal and replacement of IUD
undiagnosed abnormal uterine bleeding prior to placement of IUD
bleeding dyscrasia
anti-coagulation use
active cervicitis
allergy to tamoxifen
history of venous thromboembolism
personal history of breast or uterine malignancy
use of medication contraindicated with use of tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02824224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.