NCT03428854

Brief Summary

Examination of genomic and biologic responses to LNG-IUS in patients with adenomyosis.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2020

Status
withdrawn

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

February 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
2.8 years until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

February 5, 2018

Last Update Submit

January 28, 2021

Conditions

AdenomyosisAbnormal Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

  • Menstrual blood loss

    Pictorial blood loss assessment chart

    12 months

Secondary Outcomes (2)

  • Quality of Life

    12 months

  • Pain

    12 months

Interventions

LNG-IUSDRUG

Levnorgestrel containing IUD

Also known as: Mirena

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsUterus required
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women with abnormal uterine bleeding due to adenomyosis

You may qualify if:

  • Abnormal bleeding in the presence of Adenomyosis as demonstrated by MRI

You may not qualify if:

  • Other causes of abnormal bleeding such as fibroids, endometrial polyps, malignancy
  • Presence of endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Endometrial biopsy samples

MeSH Terms

Conditions

AdenomyosisMetrorrhagia

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 12, 2018

Study Start

December 1, 2020

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

February 2, 2021

Record last verified: 2021-01