ClinicalTrials.gg
WithdrawnNCT03428854Updated Feb 2, 2021

Adenomyosis: Genomic Mechanisms and Biological Response

An observational study in Adenomyosis and Abnormal Uterine Bleeding, sponsored by University of Texas Southwestern Medical Center. Withdrawn. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-02-02.

Sponsored by University of Texas Southwestern Medical Center · Observational

Why this study was withdrawn
The study never got funded so never started enrolling
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Adenomyosis
  • Abnormal Uterine Bleeding
03

In context

Adenomyosis

142 studies on the registry are indexed under Adenomyosis; 54 are open to participants now.

Browse Adenomyosis studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

Women with abnormal uterine bleeding due to adenomyosis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Other causes of abnormal bleeding such as fibroids, endometrial polyps,
  • Presence of endometriosis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Levnorgestrel containing IUD

    Also known as: Mirena

06

What researchers measure

Primary outcomes

  1. Menstrual blood loss

    Pictorial blood loss assessment chart

    Time frame: 12 months

Secondary outcomes

  1. Quality of Life

    SF-12

    Time frame: 12 months

  2. Pain

    Visual analog scale

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2020; primary completion for Oct 2022, 22 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2018
First posted
Feb 12, 2018
StartEst.
Dec 1, 2020
Primary completionEst.
Oct 1, 2022
CompletionEst.
Oct 1, 2022
Last update
Feb 2, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03428854
Responsible party
Kimberly Kho (Associate Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Feb 12, 2018
Start date
Dec 1, 2020 (estimated)
Primary completion
Oct 1, 2022 (estimated)
Completion
Oct 1, 2022 (estimated)
Last update
Feb 2, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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