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

Primary Purpose

Menorrhagia, Metrorrhagia, Medicated Intrauterine Devices

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Tamoxifen

Placebo (for Tamoxifen)

About this trial

This is an interventional prevention trial for Menorrhagia focused on measuring levonorgestrel, breakthrough bleeding

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleAccepts 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)

Sites / Locations

OHSU Center For Women's Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tamoxifen

Placebo

Arm Description

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

Adverse Events

Descriptive reporting of adverse events for each arm

Full Information

NCT ID

NCT02824224

First Posted

July 2, 2016

Last Updated

May 23, 2019

Sponsor

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT02824224

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

September 6, 2016 (Actual)

Primary Completion Date

January 8, 2018 (Actual)

Study Completion Date

January 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menorrhagia, Metrorrhagia, Medicated Intrauterine Devices

Keywords

levonorgestrel, breakthrough bleeding

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tamoxifen

Arm Type

Experimental

Arm Description

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Intervention Type

Drug

Intervention Name(s)

Tamoxifen

Other Intervention Name(s)

Nolvadex

Intervention Description

10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

Intervention Type

Drug

Intervention Name(s)

Placebo (for Tamoxifen)

Intervention Description

Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Primary Outcome Measure Information:

Title

Number of Bleeding and Spotting Days

Description

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 Outcome Measure Information:

Title

Bleeding Pattern Satisfaction

Description

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

Title

IUD Satisfaction

Description

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

Title

Adverse Events

Description

Descriptive reporting of adverse events for each arm

Time Frame

30 days after initiation of study drug

Other Pre-specified Outcome Measures:

Title

Total Number of Bleeding/Spotting Episodes

Time Frame

60 days after initiation of study drug

Title

Number of Prolonged Bleeding Episodes (>8 Days)

Time Frame

60 days after initiation of study drug

Title

Longest Bleed-free Interval

Time Frame

60 days after initiation of study drug

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Megan A Cohen, MD, MPH

Organizational Affiliation

Oregon Health and Science University

Official's Role

Study Director

Facility Information:

Facility Name

OHSU Center For Women's Health

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31226322

Citation

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.

Results Reference

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

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