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

• Status: Completed
• Trial end date: 2018-01-08
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon Health and Science University
• Treatments: Levonorgestrel; Tamoxifen

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)