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

Oregon Health & Science University (OHSU)

Status and phase

Completed

Phase 4

Conditions

Metrorrhagia

Menorrhagia

Medicated Intrauterine Devices

Treatments

Drug: Tamoxifen

Drug: Placebo (for Tamoxifen)

Study type

Interventional

Funder types

Other

Identifiers

NCT02824224

STUDY00015881

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

Female

Ages

15 to 45 years old

Volunteers

Accepts Healthy Volunteers

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)