Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357442
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-14
Brief Title:
Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Continuous Oral Micronized Progesterone Versus the Etonogestrel Implant a Prospective Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to compare endometrial stripe thickness in adolescent and young adult AYA patients with a uterus on estrogen replacement therapy using oral progesterone versus the etonogstrel implant for endometrial protection
The main questions it aims to answer are
Aim 1 Characterize the mean endometrial thickness in AYA on estrogen hormone replacement therapy before initiation of progesterone therapy
Aim 2 Characterize the mean changes and variability in endometrial thickness in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesterone
Aim 3 Assess satisfaction side effects bleeding patterns any progesterone modifications and adherence in AYA treated for 6 months with either etonogestrel implant or continuous progesterone
Participants will be asked to
Get two pelvic ultrasounds
Fill out two surveys
Continue their current hormone replacement therapy
Initiate one of two progesterone therapies prometrium 100mg daily or Nexplanon
Researchers will compare the change in endometrial thickness after 6 months of progesterone use to see if there is a significant difference in the mean change between the prometrium and Nexplanon groups
The main questions it aims to answer are
Aim 1 Characterize the mean endometrial thickness in AYA on estrogen hormone replacement therapy before initiation of progesterone therapy
Aim 2 Characterize the mean changes and variability in endometrial thickness in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesterone
Aim 3 Assess satisfaction side effects bleeding patterns any progesterone modifications and adherence in AYA treated for 6 months with either etonogestrel implant or continuous progesterone
Participants will be asked to
Get two pelvic ultrasounds
Fill out two surveys
Continue their current hormone replacement therapy
Initiate one of two progesterone therapies prometrium 100mg daily or Nexplanon
Researchers will compare the change in endometrial thickness after 6 months of progesterone use to see if there is a significant difference in the mean change between the prometrium and Nexplanon groups
Detailed Description:
Study Design and Research Methods This study is a prospective observational pilot study to assess the acceptability of study procedures and describe initial trends in our outcomes of interest including endometrial stripe thickness among patients on estrogen replacement therapy after six months of either continuous oral micronized progesterone or etonogestrel implant Participants will self-select into one of two study arms 1 oral micronized progesterone Prometrium 100mg daily or 2 etonogestrel implant Nexplanon
Recruitment and Enrollment Providers will identify eligible patients at routine appointments in the Childrens Hospital Colorado Pediatric and Adolescent Gynecology Clinics Endocrine Clinic Oncofertility Clinic and Multidisciplinary Turner Syndrome Clinic Providers will briefly discuss the study to assess patient interest and if the patient expresses interest patients will be approached by a member of the study team for potential study enrollment A member of the study team will provide an in-depth explanation of the study answer any questions and review the informed consent form
If a patient decides to participate in the study they or their legal guardian will provide a digital signature on the eConsent form and eAssent form for participants aged 12-17 If participants would like a copy of the eConsent form a signed copy will be emailed to the address they provide The original consent will be stored in the secure password protected REDCap database
Feasibility and Timeline We will be enrolling from the following Childrens Hospital Colorado-affiliated clinics Pediatric and Adolescent Gynecology Clinic Endocrine Clinic Oncofertility Clinic and Multidisciplinary Turners Clinic Each of these clinics routinely treats pediatric and adolescent patients requiring hormone replacement therapy We anticipate meeting enrollment goals within one year In a review of ICD codes for primary ovarian failure 313 patients presented to CHCO from October 1 2022 to October 1 2023 Of these patients 87 were under the age of 25 and received prescriptions for estradiol We anticipate a 15 enrollment rate 3-4 patients per month which translates to an 11-to-12-month enrollment period We also anticipate that recruitment in the oral progesterone arm will be significantly higher compared to the etonogestrel implant group 71 based on clinical experience Thus we anticipate that recruitment may take longer in this group but will not have an enrollment timing estimate until enrollment begins The recruitment timing of this pilot study will help inform the timeline and feasibility of a full study in the future
Due to lack of existing literature we do not know the optimal time to assess changes in endometrial thickness after hormone initiation in this exact study population ACOG clinical consensus for endometrial hyperplasia is to perform histologic re-assessment of the endometrium 3-6 months after initiating progestin therapy for treatment27 The initial clinical trials for the etonogestrel implant reference counseling patients that their bleeding pattern after 3-6 months of use will persist due to hormonal influence on the endometrium24 Additionally the only available study on the effect of desogstrel the precursor hormone to etonogestrel on endometrial protection and menstruation normalization among reproductive aged women was a 6 month randomized control trial 25 Thus by extrapolating this available data we will plan on a 6 month study timeline to allow enough time for endometrial changes to occur before performing a repeat ultrasound
Data Collection The study team will conduct a base-line survey over the phone to collect relevant clinical history eg ovarian failure diagnoses previous hormone treatments etc stored securely in a REDCap database
Participants will have a formal limited transabdominal pelvic ultrasound performed at two time points during the study The first ultrasound will be performed at enrollment baseline on estrogen therapy alone to measure endometrial thickness prior to initiation or progesterone Baseline ultrasounds will be ordered and scheduled for the patient at Childrens Hospital Colorado at enrollment Radiology technicians will perform the ultrasound and a radiologist will confirm and report ultrasound results in the participants medical record per standard of care
After a baseline ultrasound is obtained participants will initiate their selected progesterone therapies Participants that select to oral progesterone will be prescribed 100mg oral micronized progesterone daily Prometrium for 6 months Participants who elect for an etonogestrel implant will have a clinic appointment made in the Pediatric and Adolescent Gynecology Clinic at Childrens Hospital Colorado for a Nexplanon insertion that will be performed per standard protocol The study team will track the date of progesterone therapy initiation and schedule a second ultrasound for six-months after progesterone initiation - 7 days
The second ultrasound will be performed after 6 months of progesterone therapy Radiology technicians-blinded to the treatment groups-will measure the endometrial lining while performing the ultrasound The radiologist will confirm and transcribe these results in an ultrasound report in the participants medical record A single reviewer board certified in gynecology will confirm endometrial stripe measurements as documented by the radiologist -02cm If there is discordance between measurements a third gynecologist will review the ultrasound and make the final assessment of endometrial stripe thickness to ensure consistency with measurements
In addition to ultrasound data the study team will collect participant self-report data Participants will be asked to complete brief REDCap questionaries at 3- and 6 months after progesterone initiation Questionnaires will query participants demographic characteristics bleeding patterns side effects satisfaction and adherence to the medication For participants in the micronized progesterone treatment arm they will be asked to save and bring their pill bottles at the 6 month visit a total of two pill bottles the study team will perform pill counts or patients will upload a picture to their file of their remaining pills to assess compliance
All data will be stored securely in the REDCap database Participants will be compensated a total of 50 in gift cards for their participation in the study per table below
D Description Risks and Justification of Procedures and Data Collection Tools
This study involves minimal risks to participants There is a potential risk for loss of privacy and confidentiality Every reasonable effort will be made to protect participant information All data will be stored in a secure HIPAA-compliant REDCap database Only authorized users that have completed the appropriate trainings will be granted access to the REDCap project Data containing patient identifiers MRNs service dates will only be stored in the project database for organizational purposes and will not be exported into the final data set used for analysis Only de-identified data will be analyzed reported in future publications
In terms of safety of ultrasound in this patient population pelvic ultrasounds are routinely used in the field of pediatric and adolescent gynecology and is the preferred imaging modality to identify pelvic structures Ultrasounds themselves are safe with no ionizing radiation or risk to surrounding structures with use of ultrasound itself A trans-abdominal approach to pelvic ultrasound is often used in young adolescent patients due to its less invasive nature However the gold standard for identifying pelvic structures in particular the endometrial lining is use of a transvaginal ultrasound probe The transvaginal ultrasound probe can be painful and invasive for patients especially those who have never used tampons or are not sexually active Therefore we will give our patients the option for the ultrasound approach with which they are most comfortable
Data Safety and Monitoring Plan Definitions
1 Adverse Events AE An AE is defined as any unfavorable medical occurrence in a human subject temporarily associated with the subjects participation in the research study regardless of relationship to research participation For the purposes of this study AEs include any events that occur because of a study procedure ie transabdominal ultrasound As this study observes the effects of a progesterone therapy selected by the participant as part of their standard of care events that occur because of the progesterone are monitored and managed by the participants clinical team
2 Serious Adverse Events SAE SAEs are defined as any adverse event associated with a subjects participation in research that is life threatening requires inpatient hospitalization results in a significant disability results in a fetal anomaly or results in death
3 Unanticipated Problems UPs UPs can include AESAEs that are unanticipated events related directly to participant safety or protocol deviations that put participant privacy or confidentiality at risk These UPs are unexpected related to participation in research and place participants at a greater risk of harm than was previously known or recognized
4 Protocol Deviations A generally unplanned deviation from the protocol that is not implemented or intended as a systematic change to the study protocol This may include enrollment of an ineligible participant and missed study visits ie ultrasounds
Assessments The study PI will collect all AEs from the date informed consent is signed until the final study visit All AEs SAEs UPs and protocol deviations will be captured on the appropriate case report form CRF Information collected will include event description time of onset assessment of seriousness severity relationship to study procedures expectedness medical care received outcomes of event and time of resolution
Reporting All AEs will be reported to COMIRB in aggregate as part of the continuing review All SAEs will be reported to COMIRB within 48 hours of the Study PI becoming aware of the event If UPs occur during the study they will be reported to COMIRB within 48 hours of the Study PI becoming aware of the event further protocol deviations that influence participant safety will be reported to COMIRB within 48 hours of PI awareness
Monitoring The primary investigator is responsible for ensuring participants safety throughout this study and for reporting AEs SAEs and UPs to COMIRB according to the timeframes listed above The PI will review procedures for maintaining the confidentiality of the data the quality of data collection data management and analyses on a semiannual basis
Data Analysis Plan
Endometrial lining thickness and character will be collected via formal ultrasound report by the radiologist We will report descriptive statistics for all outcomes of interest including continuous endometrial thickness and categorical descriptors provided in the ultrasound report Descriptive statistics will be presented for factors that may influence patients estrogen levels and response to estrogen replacement including etiology of the patients ovarian failure current estrogen therapy formulations and doses BMI age and treatment group Due to the potential for self-selection bias we will compare the descriptive characteristics of the baseline endometrial lining by treatment group to investigate potential differences that may exist prior to treatment that may influence the primary outcome
We will report descriptive statistics for each of the outcomes of interest For categorical variables we will report count and proportion and for continuous variables we will report mean SD median and IQR We will descriptively compare the outcomes between the two treatment groups All data will be collected and managed using REDCap
The change in endometrial thickness will be calculated by comparing ultrasound findings at 6 months compared to patients baseline ultrasound Descriptive statistics will be reported for change in endometrial thickness by group including mean standard deviation SD range median and interquartile range IQR We will assess the distribution of the outcome using graphical methods and we will use a parametric or non-parametric test as appropriate We will test for a significant difference in the mean change between groups using a two-sample t-test in the case of a parametric distribution and a Mann-Whitney-Wilcoxon test in the case of a non-parametric distribution Data analysis will be conducted using R411
Power and Sample Size We will enroll 34 participants with at least 10 in each group daily oral micronized progesterone or etonogestrel implant and ideally 17 in each group The study team will carefully track the number of participants enrolled in each group When 17 are achieved in one group study enrollment into that group will close The study team will continue to present the study to eligible individuals and track the number interested in the closed treatment arm Those individuals will be informed that they are not eligible for participation and thanked for their time A sample of 34 participants who complete the study will achieve 80 power to detect a mean difference of 1 unit mm with a standard deviation of 1 unit This sample size will also provide sufficient data to estimate a mean and standard deviation in the two study groups to help power a non-inferiority design in a larger study
Summarize Knowledge to be Gained
This is a prospective study at a large tertiary center with high rates of hormone replacement therapy prescription for adolescent and young adult females The information gained through this study is to generate pilot data for a larger multisite study Our long-term goals are to evaluate endometrial thickness based on imaging findings and to correlate these findings histologically via endometrial biopsies
The proposed interventions of oral progesterone and the etonogestrel implant are safe medications that are accessible and already used widely in this patient population We know that a trans-abdominal pelvic ultrasound to assess endometrial stripe thickness is a safe non-invasive and inexpensive method to evaluate endometrial thickness To our knowledge this is the first study to assess the effects of continuous progestin therapy in the pre-menopausal patient population regarding endometrial protection Further it is the first study of its kind to evaluate the effects of continuous etonogestrel and the etonogestrel implant on endometrial thickening in any patient population
Currently there is a lack of research on the effect of the etonogestrel implant on endometrial thickness among patients using estrogen replacement therapy Additionally there is no available data regarding continuous oral micronized progesterone for the use of endometrial protection among patients using hormone replacement therapy who are not post-menopausal This initial pilot data will provide a basis on how to best perform and power a future non-inferiority study
There is also a lack of research on bleeding patterns among AYA female patients on combination hormone replacement therapy Bothersome bleeding is one of the most common reasons for non-compliance and discontinuation of HRT in clinical practice thus it is prudent to determine differences in bleeding profiles between progesterone therapies Additionally we know that patients who are amenorrheic may have a different character and thickness to their endometrial stripe on ultrasound compared to those who are not amenorrheic Gathering this information will allow us to stratify our analysis of endometrial thickness based on patients reported bleeding patterns
Studies that have evaluated and characterized endometrial stripe thickness via ultrasound have focused on post-menopausal populations There is no standard endometrial thickness in the pre-menopausal population that is deemed to be pathologic or that requires intervention Characterizing the endometrial lining on estrogen replacement therapy prior to initiating progesterone will both provide novel information about ultrasound findings of the endometrial lining in this patient population It will also offer a baseline assessment by which to measure a change in endometrial thickness over the course of six months of progesterone therapy between study groups
Recruitment and Enrollment Providers will identify eligible patients at routine appointments in the Childrens Hospital Colorado Pediatric and Adolescent Gynecology Clinics Endocrine Clinic Oncofertility Clinic and Multidisciplinary Turner Syndrome Clinic Providers will briefly discuss the study to assess patient interest and if the patient expresses interest patients will be approached by a member of the study team for potential study enrollment A member of the study team will provide an in-depth explanation of the study answer any questions and review the informed consent form
If a patient decides to participate in the study they or their legal guardian will provide a digital signature on the eConsent form and eAssent form for participants aged 12-17 If participants would like a copy of the eConsent form a signed copy will be emailed to the address they provide The original consent will be stored in the secure password protected REDCap database
Feasibility and Timeline We will be enrolling from the following Childrens Hospital Colorado-affiliated clinics Pediatric and Adolescent Gynecology Clinic Endocrine Clinic Oncofertility Clinic and Multidisciplinary Turners Clinic Each of these clinics routinely treats pediatric and adolescent patients requiring hormone replacement therapy We anticipate meeting enrollment goals within one year In a review of ICD codes for primary ovarian failure 313 patients presented to CHCO from October 1 2022 to October 1 2023 Of these patients 87 were under the age of 25 and received prescriptions for estradiol We anticipate a 15 enrollment rate 3-4 patients per month which translates to an 11-to-12-month enrollment period We also anticipate that recruitment in the oral progesterone arm will be significantly higher compared to the etonogestrel implant group 71 based on clinical experience Thus we anticipate that recruitment may take longer in this group but will not have an enrollment timing estimate until enrollment begins The recruitment timing of this pilot study will help inform the timeline and feasibility of a full study in the future
Due to lack of existing literature we do not know the optimal time to assess changes in endometrial thickness after hormone initiation in this exact study population ACOG clinical consensus for endometrial hyperplasia is to perform histologic re-assessment of the endometrium 3-6 months after initiating progestin therapy for treatment27 The initial clinical trials for the etonogestrel implant reference counseling patients that their bleeding pattern after 3-6 months of use will persist due to hormonal influence on the endometrium24 Additionally the only available study on the effect of desogstrel the precursor hormone to etonogestrel on endometrial protection and menstruation normalization among reproductive aged women was a 6 month randomized control trial 25 Thus by extrapolating this available data we will plan on a 6 month study timeline to allow enough time for endometrial changes to occur before performing a repeat ultrasound
Data Collection The study team will conduct a base-line survey over the phone to collect relevant clinical history eg ovarian failure diagnoses previous hormone treatments etc stored securely in a REDCap database
Participants will have a formal limited transabdominal pelvic ultrasound performed at two time points during the study The first ultrasound will be performed at enrollment baseline on estrogen therapy alone to measure endometrial thickness prior to initiation or progesterone Baseline ultrasounds will be ordered and scheduled for the patient at Childrens Hospital Colorado at enrollment Radiology technicians will perform the ultrasound and a radiologist will confirm and report ultrasound results in the participants medical record per standard of care
After a baseline ultrasound is obtained participants will initiate their selected progesterone therapies Participants that select to oral progesterone will be prescribed 100mg oral micronized progesterone daily Prometrium for 6 months Participants who elect for an etonogestrel implant will have a clinic appointment made in the Pediatric and Adolescent Gynecology Clinic at Childrens Hospital Colorado for a Nexplanon insertion that will be performed per standard protocol The study team will track the date of progesterone therapy initiation and schedule a second ultrasound for six-months after progesterone initiation - 7 days
The second ultrasound will be performed after 6 months of progesterone therapy Radiology technicians-blinded to the treatment groups-will measure the endometrial lining while performing the ultrasound The radiologist will confirm and transcribe these results in an ultrasound report in the participants medical record A single reviewer board certified in gynecology will confirm endometrial stripe measurements as documented by the radiologist -02cm If there is discordance between measurements a third gynecologist will review the ultrasound and make the final assessment of endometrial stripe thickness to ensure consistency with measurements
In addition to ultrasound data the study team will collect participant self-report data Participants will be asked to complete brief REDCap questionaries at 3- and 6 months after progesterone initiation Questionnaires will query participants demographic characteristics bleeding patterns side effects satisfaction and adherence to the medication For participants in the micronized progesterone treatment arm they will be asked to save and bring their pill bottles at the 6 month visit a total of two pill bottles the study team will perform pill counts or patients will upload a picture to their file of their remaining pills to assess compliance
All data will be stored securely in the REDCap database Participants will be compensated a total of 50 in gift cards for their participation in the study per table below
D Description Risks and Justification of Procedures and Data Collection Tools
This study involves minimal risks to participants There is a potential risk for loss of privacy and confidentiality Every reasonable effort will be made to protect participant information All data will be stored in a secure HIPAA-compliant REDCap database Only authorized users that have completed the appropriate trainings will be granted access to the REDCap project Data containing patient identifiers MRNs service dates will only be stored in the project database for organizational purposes and will not be exported into the final data set used for analysis Only de-identified data will be analyzed reported in future publications
In terms of safety of ultrasound in this patient population pelvic ultrasounds are routinely used in the field of pediatric and adolescent gynecology and is the preferred imaging modality to identify pelvic structures Ultrasounds themselves are safe with no ionizing radiation or risk to surrounding structures with use of ultrasound itself A trans-abdominal approach to pelvic ultrasound is often used in young adolescent patients due to its less invasive nature However the gold standard for identifying pelvic structures in particular the endometrial lining is use of a transvaginal ultrasound probe The transvaginal ultrasound probe can be painful and invasive for patients especially those who have never used tampons or are not sexually active Therefore we will give our patients the option for the ultrasound approach with which they are most comfortable
Data Safety and Monitoring Plan Definitions
1 Adverse Events AE An AE is defined as any unfavorable medical occurrence in a human subject temporarily associated with the subjects participation in the research study regardless of relationship to research participation For the purposes of this study AEs include any events that occur because of a study procedure ie transabdominal ultrasound As this study observes the effects of a progesterone therapy selected by the participant as part of their standard of care events that occur because of the progesterone are monitored and managed by the participants clinical team
2 Serious Adverse Events SAE SAEs are defined as any adverse event associated with a subjects participation in research that is life threatening requires inpatient hospitalization results in a significant disability results in a fetal anomaly or results in death
3 Unanticipated Problems UPs UPs can include AESAEs that are unanticipated events related directly to participant safety or protocol deviations that put participant privacy or confidentiality at risk These UPs are unexpected related to participation in research and place participants at a greater risk of harm than was previously known or recognized
4 Protocol Deviations A generally unplanned deviation from the protocol that is not implemented or intended as a systematic change to the study protocol This may include enrollment of an ineligible participant and missed study visits ie ultrasounds
Assessments The study PI will collect all AEs from the date informed consent is signed until the final study visit All AEs SAEs UPs and protocol deviations will be captured on the appropriate case report form CRF Information collected will include event description time of onset assessment of seriousness severity relationship to study procedures expectedness medical care received outcomes of event and time of resolution
Reporting All AEs will be reported to COMIRB in aggregate as part of the continuing review All SAEs will be reported to COMIRB within 48 hours of the Study PI becoming aware of the event If UPs occur during the study they will be reported to COMIRB within 48 hours of the Study PI becoming aware of the event further protocol deviations that influence participant safety will be reported to COMIRB within 48 hours of PI awareness
Monitoring The primary investigator is responsible for ensuring participants safety throughout this study and for reporting AEs SAEs and UPs to COMIRB according to the timeframes listed above The PI will review procedures for maintaining the confidentiality of the data the quality of data collection data management and analyses on a semiannual basis
Data Analysis Plan
Endometrial lining thickness and character will be collected via formal ultrasound report by the radiologist We will report descriptive statistics for all outcomes of interest including continuous endometrial thickness and categorical descriptors provided in the ultrasound report Descriptive statistics will be presented for factors that may influence patients estrogen levels and response to estrogen replacement including etiology of the patients ovarian failure current estrogen therapy formulations and doses BMI age and treatment group Due to the potential for self-selection bias we will compare the descriptive characteristics of the baseline endometrial lining by treatment group to investigate potential differences that may exist prior to treatment that may influence the primary outcome
We will report descriptive statistics for each of the outcomes of interest For categorical variables we will report count and proportion and for continuous variables we will report mean SD median and IQR We will descriptively compare the outcomes between the two treatment groups All data will be collected and managed using REDCap
The change in endometrial thickness will be calculated by comparing ultrasound findings at 6 months compared to patients baseline ultrasound Descriptive statistics will be reported for change in endometrial thickness by group including mean standard deviation SD range median and interquartile range IQR We will assess the distribution of the outcome using graphical methods and we will use a parametric or non-parametric test as appropriate We will test for a significant difference in the mean change between groups using a two-sample t-test in the case of a parametric distribution and a Mann-Whitney-Wilcoxon test in the case of a non-parametric distribution Data analysis will be conducted using R411
Power and Sample Size We will enroll 34 participants with at least 10 in each group daily oral micronized progesterone or etonogestrel implant and ideally 17 in each group The study team will carefully track the number of participants enrolled in each group When 17 are achieved in one group study enrollment into that group will close The study team will continue to present the study to eligible individuals and track the number interested in the closed treatment arm Those individuals will be informed that they are not eligible for participation and thanked for their time A sample of 34 participants who complete the study will achieve 80 power to detect a mean difference of 1 unit mm with a standard deviation of 1 unit This sample size will also provide sufficient data to estimate a mean and standard deviation in the two study groups to help power a non-inferiority design in a larger study
Summarize Knowledge to be Gained
This is a prospective study at a large tertiary center with high rates of hormone replacement therapy prescription for adolescent and young adult females The information gained through this study is to generate pilot data for a larger multisite study Our long-term goals are to evaluate endometrial thickness based on imaging findings and to correlate these findings histologically via endometrial biopsies
The proposed interventions of oral progesterone and the etonogestrel implant are safe medications that are accessible and already used widely in this patient population We know that a trans-abdominal pelvic ultrasound to assess endometrial stripe thickness is a safe non-invasive and inexpensive method to evaluate endometrial thickness To our knowledge this is the first study to assess the effects of continuous progestin therapy in the pre-menopausal patient population regarding endometrial protection Further it is the first study of its kind to evaluate the effects of continuous etonogestrel and the etonogestrel implant on endometrial thickening in any patient population
Currently there is a lack of research on the effect of the etonogestrel implant on endometrial thickness among patients using estrogen replacement therapy Additionally there is no available data regarding continuous oral micronized progesterone for the use of endometrial protection among patients using hormone replacement therapy who are not post-menopausal This initial pilot data will provide a basis on how to best perform and power a future non-inferiority study
There is also a lack of research on bleeding patterns among AYA female patients on combination hormone replacement therapy Bothersome bleeding is one of the most common reasons for non-compliance and discontinuation of HRT in clinical practice thus it is prudent to determine differences in bleeding profiles between progesterone therapies Additionally we know that patients who are amenorrheic may have a different character and thickness to their endometrial stripe on ultrasound compared to those who are not amenorrheic Gathering this information will allow us to stratify our analysis of endometrial thickness based on patients reported bleeding patterns
Studies that have evaluated and characterized endometrial stripe thickness via ultrasound have focused on post-menopausal populations There is no standard endometrial thickness in the pre-menopausal population that is deemed to be pathologic or that requires intervention Characterizing the endometrial lining on estrogen replacement therapy prior to initiating progesterone will both provide novel information about ultrasound findings of the endometrial lining in this patient population It will also offer a baseline assessment by which to measure a change in endometrial thickness over the course of six months of progesterone therapy between study groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None