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

Completed · Phase 4 · Has a placebo group

Conditions studied: Menorrhagia, Metrorrhagia, Medicated Intrauterine Devices

In brief

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.

Key facts

Study ID

NCT02824224

Run by

Oregon Health and Science University

People needed

42

Starts

2016-09-06

Expected to finish

2018-01-08

Last updated by the study team

2019-06-04

Who can join

Age: 15 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• OHSU Center For Women's Health — Portland, Oregon, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.