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

Phase 4

Completed

• Conditions: Metrorrhagia; Menorrhagia; Medicated Intrauterine Devices
• Interventions: Drug: Tamoxifen; Drug: Placebo (for Tamoxifen)

• Registration Number: NCT02824224
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-07-02
• Study First Submitted QC: 2016-07-02
• Study First Posted: 2016-07-06
• Study Start: 2016-09-06
• Primary Completion: 2018-01-08
• Study Completion: 2018-01-08
• Results First Submitted: 2019-04-08
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-03
• Results First Posted: 2019-05-21
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamoxifen	Tamoxifen	Tamoxifen 10mg tablet by mouth twice daily for 7 days
Placebo	Placebo (for Tamoxifen)	Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Primary Outcome Measures

Name	Time	Method
Number of Bleeding and Spotting Days	30 days after initiation of study drug	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

Secondary Outcome Measures

Name	Time	Method
IUD Satisfaction	30 days after initiation of study drug	0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with IUD (intrauterine device). 0 mm = not at all satisfied, 100 mm = very satisfied.
Adverse Events	30 days after initiation of study drug	Descriptive reporting of adverse events for each arm
Bleeding Pattern Satisfaction	30 days after initiation of study drug	0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with bleeding pattern. 0 mm = not at all satisfied, 100 mm = very satisfied.

Trial Locations

Locations (1)

OHSU Center For Women's Health; 🇺🇸 Portland, Oregon, United States