NCT02824224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 6, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 21, 2019

Completed
Last Updated

June 4, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

July 2, 2016

Results QC Date

April 8, 2019

Last Update Submit

May 23, 2019

Conditions

MenorrhagiaMetrorrhagiaMedicated Intrauterine Devices

Keywords

levonorgestrelbreakthrough bleeding

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Bleeding Pattern Satisfaction

    30 days after initiation of study drug

  • IUD Satisfaction

    30 days after initiation of study drug

  • Adverse Events

    30 days after initiation of study drug

Other Outcomes (3)

  • 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

Study Arms (2)

Tamoxifen

EXPERIMENTAL

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Drug: Tamoxifen

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (for Tamoxifen)

Interventions

TamoxifenDRUG

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

Also known as: Nolvadex
Tamoxifen
Placebo (for Tamoxifen)DRUG

Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Placebo

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU Center For Women's Health

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

    PMID: 31226322DERIVED

MeSH Terms

Conditions

MenorrhagiaMetrorrhagia

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Ob/Gyn Regulatory Specialist
Organization
Oregon Health & Science University
mccrimmo@ohsu.edu
5034940757

Study Officials

  • Megan A Cohen, MD, MPH

    Oregon Health and Science University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Leon Speroff Professor of Obstetrics & Gynecology

Study Record Dates

First Submitted

July 2, 2016

First Posted

July 6, 2016

Study Start

September 6, 2016

Primary Completion

January 8, 2018

Study Completion

January 8, 2018

Last Updated

June 4, 2019

Results First Posted

May 21, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)