Adenomyosis: Genomic Mechanisms and Biological Response
Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03428854
Collaborator
(none)
0
22
Study Details
Study Description
Brief Summary
Examination of genomic and biologic responses to LNG-IUS in patients with adenomyosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Examination of genomic and biologic responses to LNG-IUS in patients with adenomyosis.
Study Design
Study Type:
Observational
Actual Enrollment
:
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Adenomyosis: Genomic Mechanisms and Biological Response
Anticipated Study Start Date
:
Dec 1, 2020
Anticipated Primary Completion Date
:
Oct 1, 2022
Anticipated Study Completion Date
:
Oct 1, 2022
Outcome Measures
Primary Outcome Measures
- Menstrual blood loss [12 months]
Pictorial blood loss assessment chart
Secondary Outcome Measures
- Quality of Life [12 months]
SF-12
- Pain [12 months]
Visual analog scale
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
Female
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Texas Southwestern Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Kimberly Kho,
Associate Professor,
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT03428854
Other Study ID Numbers:
- 0000
First Posted:
Feb 12, 2018
Last Update Posted:
Feb 2, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: