LevonorgestrelNCT07382583
Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer
An observational study of Levonorgestrel and Intrauterine Systems, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
To develop an educational tool to help patients and healthcare professionals make informed decisions about endometrial cancer and available prevention options for it (such as the use of a levonorgestrel-releasing intrauterine system [LNG-IUS]). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Levonorgestrel, Intrauterine Systems, Prevention
- What is being tested?
- Survey using a questionnaire
- How many people
- 270 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2026to 1 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: MD Anderson Cancer Center
Who may be able to join
- Unaffected women
- Must be at least 18 years old
- Must read and speak English or Spanish
- Must be premenopausal
- Must not have a prior history of EC or complex atypical hyperplasia
- Must provide written, informed consent
Show all 18Show fewer
- No physical, psychological, or cognitive impairments that would preclude participation in an interview as determined by the PI or study team member
- Affected women
- Must be at least 18 years old
- Must read and speak English or Spanish
- Must have a prior history of EC or complex atypical hyperplasia
- Must provide written, informed consent
- No physical, psychological, or cognitive impairments that would preclude participation in an interview as determined by the PI or study team member
- Healthcare Providers
- Physicians or advanced practice providers (physician assistants, nurse practitioners) from Family Medicine, Obstetrics \& Gynecology, Internal Medicine, or Endocrinology
- Must be at least 18 years old
- Must read and speak English or Spanish
- Must provide written, informed consent for qualitative interviews
Who cannot join
- N/A
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Harris Health System (LBJ)
Houston, Texas, 77026
Larissa Meyer, MD, 281-682-8359, lmeyer@mdanderson.org
Larissa Meyer, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Larissa A Meyer, MD, 713-745-0973, lmeyer@mdanderson.org
Larissa A Meyer, MD
About this study
To develop an educational tool to help patients and healthcare professionals make informed decisions about endometrial cancer and available prevention options for it (such as the use of a levonorgestrel-releasing intrauterine system [LNG-IUS]).
Read the detailed description
Primary Objectives
The overall goal of this study is to create a personalized decision support educational tool for the use of LNG-IUS as a primary prevention strategy for women at risk of EC. The decision support tool will not replace the consultation with a clinician. Rather, it will help prepare the participant to better understand their options and prepare them for conversations with clinicians when making a decision about use of LNG-IUS. The primary objectives will be accomplished in two phases:
Phase 1 Primary Objective:
- To identify decisional needs, participant values, and experiences for preferences regarding LNG-IUS through a mixed-methods approach
Phase 2 Primary Objective:
- To develop and field-test a novel web-based SDM tool in English and Spanish incorporating a personalized EC risk calculator and focused on LNG-IUS as a primary prevention strategy
- Conditions
- Levonorgestrel, Intrauterine Systems, Prevention, Endometrial Cancer
- Being tested
- Survey using a questionnaire
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaireOther
Patient Preference Utility Assessment and Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Identify decisional needs, patient values and experiences Receives: Other: Survey using a questionnaire | |
| Phase 2 | Develop and pilot test a web-based shared medical decision tool Receives: Other: Survey using a questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Utility Questionnaire
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start12 Feb 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LevonorgestrelStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- Other
- Time perspective
- Other
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Responsible party
- Sponsor
- Investigators
- Larissa A Meyer, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382583
- Sponsor's protocol ID
- 2025-1540
- Other IDs
- NCI-2026-00500
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the Primary Prevention of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07382583
- Acronym / sponsor ID
- 2025-1540
- Conditions
- Levonorgestrel, Intrauterine Systems, Prevention, Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 3 Feb 2026 (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.
To develop an educational tool to help patients and healthcare professionals make informed decisions about endometrial cancer and available prevention options for it (such as the use of a levonorgestrel-releasing intrauterine system [LNG-IUS]).
Detailed description
Primary Objectives
The overall goal of this study is to create a personalized decision support educational tool for the use of LNG-IUS as a primary prevention strategy for women at risk of EC. The decision support tool will not replace the consultation with a clinician. Rather, it will help prepare the participant to better understand their options and prepare them for conversations with clinicians when making a decision about use of LNG-IUS. The primary objectives will be accomplished in two phases:
Phase 1 Primary Objective:
- To identify decisional needs, participant values, and experiences for preferences regarding LNG-IUS through a mixed-methods approach
Phase 2 Primary Objective:
- To develop and field-test a novel web-based SDM tool in English and Spanish incorporating a personalized EC risk calculator and focused on LNG-IUS as a primary prevention strategy
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | – | Other: Survey using a questionnaireIdentify decisional needs, patient values and experiences |
| Phase 2 | – | Other: Survey using a questionnaireDevelop and pilot test a web-based shared medical decision tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center
Key inclusion criteria (18 listed)
- Unaffected women
- Affected women
- Healthcare Providers
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Survey using a questionnairePatient Preference Utility Assessment and Questionnaires | Other | Phase 1, Phase 2 |
Primary outcome
Patient Utility Questionnaire
Time frame: Through study completion; an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Healthy Participants
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.
Larissa A Meyer, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Levonorgestrel and Intrauterine Systems, run by M.D. Anderson Cancer Center at 2 sites in United States.
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 18 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Larissa A Meyer, MD (713-745-0973, lmeyer@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Utility Questionnaire (time frame: Through study completion; an average of 1 year). 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 12 Aug 2026.