AdenomyosisNCT03428854
Adenomyosis: Genomic Mechanisms and Biological Response
An observational study of Adenomyosis and Abnormal Uterine Bleeding, run by University of Texas Southwestern Medical Center.
Trial summary
Examination of genomic and biologic responses to LNG-IUS in patients with adenomyosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Adenomyosis, Abnormal Uterine Bleeding
- What is being tested?
- LNG-IUS
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Adult
Study population: Women with abnormal uterine bleeding due to adenomyosis
Who may be able to join
- Abnormal bleeding in the presence of Adenomyosis as demonstrated by MRI
Who cannot join
- Other causes of abnormal bleeding such as fibroids, endometrial polyps, malignancy
- Presence of endometriosis
About this study
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.
- Conditions
- Adenomyosis, Abnormal Uterine Bleeding
- Being tested
- LNG-IUS
- Medical subject headings
- Adenomyosis, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNG-IUSDrug
Also called Mirena
Levnorgestrel containing IUD
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual blood loss
Pictorial blood loss assessment chart
Measured: 12 months
Secondary outcomes (2)
Quality of Life
SF-12
Measured: 12 months
Pain
Visual analog scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start1 Dec 2020 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Why it stopped: The study never got funded so never started enrolling
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Kho, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428854
- Sponsor's protocol ID
- 0000
- Status last verified
- Jan 2021
- First submitted
- 5 Feb 2018
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenomyosis: Genomic Mechanisms and Biological Response
- ClinicalTrials.gov ID
- NCT03428854
- Acronym / sponsor ID
- 0000
- Conditions
- Adenomyosis, Abnormal Uterine Bleeding
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study never got funded so never started enrolling
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women with abnormal uterine bleeding due to adenomyosis
Key inclusion criteria (1 listed)
- Abnormal bleeding in the presence of Adenomyosis as demonstrated by MRI
Key exclusion criteria (2 listed)
- Other causes of abnormal bleeding such as fibroids, endometrial polyps, malignancy
- Presence of endometriosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LNG-IUSAlso: MirenaLevnorgestrel containing IUD | Drug | – |
Primary outcome
Menstrual blood loss
Time frame: 12 months
Pictorial blood loss assessment chart
2 secondary outcomes
Quality of Life
Time frame: 12 months
Pain
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
Related trials for Adenomyosis
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
Stellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery
Uterine Fibroids (Leiomyoma), Adenomyosis of Uterus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis and Abnormal Uterine Bleeding, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual blood loss (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.