Adenomyosis: Genomic Mechanisms and Biological Response | NCT03428854

Studies
Adenomyosis: Genomic Mechanisms and Biological Response

NCT03428854

Sponsor

University of Texas Southwestern Medical Center

Status

Withdrawn

Last Update Posted

Feb 2, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Adenomyosis
Abnormal Uterine Bleeding

Interventions

LNG-IUS

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study never got funded so never started enrolling

Expanded Access Info

Start Date

Dec 1, 2020Estimated

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Oct 1, 2022Estimated

First Submitted Date

Feb 5, 2018

First Submission Date that Met QC Criteria

Feb 5, 2018

First Posted Date

Feb 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2021

Last Update Posted Date

Feb 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kimberly Kho, Associate Professor, University of Texas Southwestern Medical CenterPrincipal Investigator

Lead Sponsor

University of Texas Southwestern Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
LNG-IUS	Drug	Levnorgestrel containing IUD		Mirena

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Menstrual blood loss	Pictorial blood loss assessment chart	12 months

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life	SF-12	12 months
Pain	Visual analog scale	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Abnormal bleeding in the presence of Adenomyosis as demonstrated by MRI

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Uterus required

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Women with abnormal uterine bleeding due to adenomyosis

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D062788	Adenomyosis
D008796	Metrorrhagia

Ancestor Terms

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016912	Levonorgestrel

Ancestor Terms

ID	Term
D009644	Norgestrel
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids
D013256

Browse Leaves

Not provided

Browse Branches

Not provided