An Observational Study to Learn How Mirena and Other Progestogen Treatments Are Used for Endometrial Protection in Women 40+ With a Uterus in the United States Receiving Estrogen Therapy, and Their Respective Health Outcomes (SHIELD-ET)
26 août 2026 mis à jour par: Bayer
Study of Real-world Use of Hormonal Levonorgestrel Intra-uterine System for Endometrial Defense With Estrogen Therapy
This is an observational study in which researchers will use claims data already collected from women in the United States who received their usual care. The study will look at women aged 40 years and older who have a uterus and started estrogen therapy.
Estrogen therapy is often used to treat menopause symptoms, such as hot flashes and night sweats, or to help prevent bone loss. Women who take estrogen and still have a uterus usually also need a progestogen to help protect the lining of the uterus. Without this protection, the lining may become too thick. This can lead to endometrial hyperplasia and may increase the risk of endometrial cancer.
This study will look at how Mirena and other progestogen treatments are used in routine medical care to protect the lining of the uterus during estrogen therapy. Mirena is a small device placed in the uterus that releases the hormone levonorgestrel (a synthetic progestogen, similar to progesterone). In the United States, Mirena is approved for birth control and for treatment of heavy menstrual bleeding. Clinicians may also use it for endometrial protection during estrogen therapy. Bayer's Mirena levonorgestrel-containing intrauterine system (LNG-IUS) 52 mg is approved for endometrial protection during hormone therapy in over 100 countries outside of the US.
The main purpose of this study is gain insight into how different progestogen treatments are used in the context of estrogen therapy in women with a uterus, and the health outcomes linked with them. Researchers will describe how often women use estrogen alone, estrogen with Mirena, or estrogen with other progestogen treatments in the past 10 years. Researchers will also look at how often endometrial hyperplasia, endometrial cancer, abnormal or heavy bleeding, and hysterectomy occur in these groups over time.
The data will come from two U.S. health insurance claims databases: Optum Clinformatics Data Mart and MarketScan Commercial Claims and Encounters Database. The study period covers 2014 through 2025, depending on the database. Optum: January 2015-December 2025 and MarketScan: October 2014-September 2025, with patient identification periods of Optum: January 2016-December 2024 and MarketScan: October 2015-September 2024. Researchers will follow each participant's available data for at least 12 months before and at least 12 months after starting estrogen therapy, with follow-up of up to 10 years.
No study treatment will be given as part of this study. Researchers will only review anonymous health insurance claims data that were already collected during routine care.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Observationnel
Inscription (Estimé)
456000
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Bayer Clinical Trials Contact
- Numéro de téléphone: 18888422937
- E-mail: clinical-trials-contact@bayer.com
Lieux d'étude
-
-
Michigan
-
Ann Arbor, Michigan, États-Unis, 48108
- Mirative MarketScan Commercial Claims and Encounters Database
-
-
Minnesota
-
Eden Prairie, Minnesota, États-Unis, 55344
- Optum Clinformatics™ Data Mart (CDM)
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
The study population for the SHIELD-ET study are patients 40+ years of age with a uterus receiving estrogen therapy.
Special populations or subpopulations among menopausal women (e.g.
chemotherapy- or drug-induced menopause), as well as women without a uterus will be excluded.
La description
Inclusion Criteria:
- At least one claim of estrogen therapy (ET) during the patient identification period (Index date: the first claim for ET)
- Age ≥ 40 years at the index date
- Patients with minimum continuous enrollment 12 months prior and 12 months at minimum after index date
Exclusion Criteria:
- Women without a uterus (claims of hysterectomy) in the 12-month baseline period
- Use of any hormonal contraception in the 12-month baseline period
- Claims indicative of atypical endometrial hyperplasia or endometrial cancer or heavy menstrual bleeding (HMB)/abnormal uterine bleeding (AUB)/postmenopausal bleeding (PMB), or any treatment for late state or metastatic endometrial cancer, in the baseline period.
- Claims in the baseline period for any of the treatments of interest
- Claims of chemotherapy/endocrine therapy in the baseline period
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Estrogen therapy (ET) unopposed
Women receiving estrogen therapy (ET) alone without evidence of concomitant progestogen use during the exposure assessment period.
|
Estrogen therapy prescribed during routine clinical practice and identified through prescription claims data.
Exposure to estrogen therapy is determined using study-specific claims-based definitions.
|
|
ET + Mirena LNG-IUS
Women receiving estrogen therapy (ET) with recurring prescription fills and evidence of Mirena levonorgestrel-releasing intrauterine system (LNG-IUS) use, identified through a Mirena insertion procedure code and/or device code during the exposure assessment period.
|
A levonorgestrel-releasing intrauterine system used for endometrial protection in women receiving estrogen therapy.
Exposure is identified through Mirena insertion procedure codes and/or device codes in claims data.
Contraception use of this product is not exposure of interest and baseline hormonal contraception is an exclusion criterion.
Autres noms:
|
|
ET + other progestogen
Women receiving estrogen therapy (ET) with recurring prescription fills and evidence of concomitant progestogen use other than Mirena LNG-IUS during the exposure assessment period.
Other progestogen therapies include progesterone, synthetic progestins, Liletta LNG-IUS 52 mg, and combination estrogen-progestogen products.
|
rogestogen therapy used for endometrial protection in women receiving estrogen therapy, including progesterone, synthetic progestins, Liletta LNG-IUS 52 mg, and combination estrogen-progestogen products.
Exposure is identified through claims data.
Contraceptive use of these products is not exposure of interest, and baseline hormonal contraception is an exclusion criterion.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of patients receiving estrogen therapy
Délai: Retrospective analysis from January 2025 to December 2025
|
Proportion of eligible female patients aged 40 years and older with a uterus who received at least one claim for estrogen therapy during the study period.
The numerator is the number of patients with at least one estrogen therapy claim during the study period, and the denominator is the number of eligible female patients contributing at least one observable person-day during the study period.
|
Retrospective analysis from January 2025 to December 2025
|
|
Number of patients by treatment subgroup within 30 and 90 days of estrogen therapy initiation
Délai: Within 30 days and 90 days after estrogen therapy initiation during the study period (January 2025 to December 2025)
|
Number of patients in each treatment subgroup (ET unopposed, ET + Mirena LNG-IUS, and ET + other progestogen) within 30 and 90 days after initiation of estrogen therapy.
|
Within 30 days and 90 days after estrogen therapy initiation during the study period (January 2025 to December 2025)
|
|
Proportion of patients by treatment subgroup within 30 and 90 days of estrogen therapy initiation
Délai: Within 30 days and 90 days after estrogen therapy initiation during the study period (January 2025 to December 2025)
|
Proportion of patients in each treatment subgroup (ET unopposed, ET + Mirena LNG-IUS, and ET + other progestogen) within 30 and 90 days after initiation of estrogen therapy.
|
Within 30 days and 90 days after estrogen therapy initiation during the study period (January 2025 to December 2025)
|
|
Average length of estrogen therapy use
Délai: Retrospective analysis from January 2025 to December 2025
|
The average length of estrogen therapy (ET) use will be expressed as the mean duration (in days) among all eligible patients.
The length of ET use will be measured as the time from the first ET prescription date to the last ET prescription date, with a maximum allowable gap of 30 days between consecutive prescriptions to be considered continuous therapy.
|
Retrospective analysis from January 2025 to December 2025
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall (10-year) incidence of atypical, non-atypical and unspecified endometrial hyperplasia, endometrial cancer, abnormal/unscheduled/heavy menstrual bleeding and hysterectomy
Délai: Retrospective analysis from January 2016 to December 2025
|
Overall incidence of atypical, non-atypical, and unspecified endometrial hyperplasia, endometrial cancer, abnormal/unscheduled/heavy menstrual bleeding, and hysterectomy among patients in each treatment subgroup (ET unopposed, ET + Mirena LNG-IUS, and ET + other progestogen).
Overall incidence will be evaluated over the 10-year study period.
For each outcome, incident cases are defined as patients with at least one new claim for the condition of interest during follow-up.
Only the first occurrence of each outcome after the index date will be counted as an incident event.
Outcomes are assessed after completion of the 30- and 90-day exposure assessment periods, and only first incident events during follow-up are counted.
|
Retrospective analysis from January 2016 to December 2025
|
|
Annual incidence of atypical, non-atypical and unspecified endometrial hyperplasia, endometrial cancer, abnormal/unscheduled/heavy menstrual bleeding and hysterectomy
Délai: Annually from January 2016 through December 2025
|
Annual incidence of atypical, non-atypical, and unspecified endometrial hyperplasia, endometrial cancer, abnormal/unscheduled/heavy menstrual bleeding, and hysterectomy among patients in each treatment subgroup (ET unopposed, ET + Mirena LNG-IUS, and ET + other progestogen).
For each outcome, incident cases are defined as patients with at least one new claim for the condition of interest during follow-up.
Patients will be counted only in the calendar year of their first occurrence for each outcome.
|
Annually from January 2016 through December 2025
|
|
Participant demographic characteristics: age
Délai: At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
|
|
Participant demographic characteristics: race
Délai: At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
|
|
Participant demographic characteristics: ethnicity
Délai: At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
|
|
Participant demographic characteristics: region
Délai: At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
|
|
Participant demographic characteristics: health plan type
Délai: At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
|
|
Gynecologic history: endometrial polyps, fibroids, adenomyosis, endometriosis
Délai: At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
|
|
Clinical characteristics: relevant comorbidities
Délai: At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
|
|
Clinical characteristics: Charlson Comorbidity Index (CCI)
Délai: At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
The CCI is a method of estimating the one-year mortality for a patient with certain comorbid conditions.
Each comorbid condition is given a score of 1, 2, 3 or 6 based on the degree of mortality attributed to the condition.
The scores are summed to yield a total index score which can be used to predict long-term survival.
Higher scores indicate a greater comorbidity burden and a higher predicted risk of mortality.
|
At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
|
Proportion of patients with a diagnosis of menopause
Délai: At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
At baseline (within 12 months before the first estrogen therapy prescription claim [index date])
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
31 août 2026
Achèvement primaire (Estimé)
30 octobre 2026
Achèvement de l'étude (Estimé)
31 décembre 2026
Dates d'inscription aux études
Première soumission
26 août 2026
Première soumission répondant aux critères de contrôle qualité
26 août 2026
Première publication (Réel)
31 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
31 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 23357
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing".
This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research.
This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research.
Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .