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

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.

Study Overview

• Status: Completed
• Conditions: Metrorrhagia; Menorrhagia; Medicated Intrauterine Devices
• Intervention / Treatment: Drug: Tamoxifen; Drug: Placebo (for Tamoxifen)

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Center For Women's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 43 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tamoxifen; Tamoxifen 10mg tablet by mouth twice daily for 7 days	Drug: Tamoxifen; 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course; Other Names: Nolvadex
Placebo Comparator: Placebo; Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days	Drug: Placebo (for Tamoxifen); Sugar pill manufactured to mimic the tamoxifen 10mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days after initiation of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	30 days after initiation of study drug
Adverse Events	Descriptive reporting of adverse events for each arm	30 days after initiation of study drug

Other Outcome Measures

Outcome Measure	Time Frame
Total Number of Bleeding/Spotting Episodes	60 days after initiation of study drug
Number of Prolonged Bleeding Episodes (>8 Days)	60 days after initiation of study drug
Longest Bleed-free Interval	60 days after initiation of study drug

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Study Director: Megan A Cohen, MD, MPH, Oregon Health and Science University

Publications and helpful links

General Publications

• Cohen MA, Simmons KB, Edelman AB, Jensen JT. Tamoxifen for the prevention of unscheduled bleeding in new users of the levonorgestrel 52-mg intrauterine system: a randomized controlled trial. Contraception. 2019 Nov;100(5):391-396. doi: 10.1016/j.contraception.2019.06.009. Epub 2019 Jun 18.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2016
• Primary Completion (Actual): January 8, 2018
• Study Completion (Actual): January 8, 2018

Study Registration Dates

• First Submitted: July 2, 2016
• First Submitted That Met QC Criteria: July 2, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: breakthrough bleeding; levonorgestrel
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Menstruation Disturbances; Uterine Hemorrhage; Hemorrhage; Metrorrhagia; Menorrhagia; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Bone Density Conservation Agents; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Tamoxifen
• Other Study ID Numbers: STUDY00015881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No