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

Oregon Health and Science University42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Menorrhagia Metrorrhagia Medicated Intrauterine Devices

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

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

OHSU Center For Women's Health

Portland, Oregon, United States

Outcomes

Primary Outcomes

Number of Bleeding and Spotting Days

Mean number of bleeding and spotting days in the tamoxifen group compared to the mean number of bleeding and spotting days in the placebo group

Time frame: 30 days after initiation of study drug

Secondary Outcomes

Bleeding Pattern Satisfaction

0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with bleeding pattern. 0 mm = not at all satisfied, 100 mm = very satisfied.

Time frame: 30 days after initiation of study drug

IUD Satisfaction

0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with IUD (intrauterine device). 0 mm = not at all satisfied, 100 mm = very satisfied.

Time frame: 30 days after initiation of study drug

Adverse Events

Descriptive reporting of adverse events for each arm

Time frame: 30 days after initiation of study drug

Data from ClinicalTrials.gov

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