Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508944
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
Efficacy of Vaginal 17β-Estradiol on the Urinary Storage Symptoms in Postmenopausal Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Vaginal 17β-Estradiol on the Urinary Storage Symptoms in Postmenopausal Women A Randomized Double-Blind Placebo-Controlled Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate whether vaginal 17β-estradiol effectively treats storage symptoms of lower urinary tract symptoms LUTS and enhances quality of life The main questions it aims to answer are
What is the efficacy of vaginal 17β-estradiol treatment compared to placebo in alleviating storage symptoms of LUTS
How does vaginal 17β-estradiol treatment affect the urethral maturation index and vaginal pH compared to placebo
What impact does vaginal 17β-estradiol treatment have on overall quality of life and patients perception of global improvement PGI
Participants in the trial will undergo the following procedures
Screening procedures at the first visit to exclude correctable causes of LUTS and to complete a bladder diary
Visit the clinic at 1-2 weeks for a review of the bladder diary and a check-up Participants will receive the assigned dosage of vaginal 17β-estradiol or placebo one vaginal tablet daily for two weeks followed by one vaginal tablet twice a week for 10 weeks
The third and fourth visits at 4 and 12 weeks after treatment will involve completion of bladder diaries questionnaires vaginal pH testing collection of urethral maturation index UMI observation of interventions side effects and monitoring of LUTS symptoms
What is the efficacy of vaginal 17β-estradiol treatment compared to placebo in alleviating storage symptoms of LUTS
How does vaginal 17β-estradiol treatment affect the urethral maturation index and vaginal pH compared to placebo
What impact does vaginal 17β-estradiol treatment have on overall quality of life and patients perception of global improvement PGI
Participants in the trial will undergo the following procedures
Screening procedures at the first visit to exclude correctable causes of LUTS and to complete a bladder diary
Visit the clinic at 1-2 weeks for a review of the bladder diary and a check-up Participants will receive the assigned dosage of vaginal 17β-estradiol or placebo one vaginal tablet daily for two weeks followed by one vaginal tablet twice a week for 10 weeks
The third and fourth visits at 4 and 12 weeks after treatment will involve completion of bladder diaries questionnaires vaginal pH testing collection of urethral maturation index UMI observation of interventions side effects and monitoring of LUTS symptoms
Detailed Description:
I First Visit and Recruitment
Participants will be recruited from the urogynecology clinic menopause clinic and urology clinic using hospital and public advertisement An information sheet in Thai language will be provided to health care providers in the designated outpatient department OPD which can ensure the providers convey the correct study information to potential participant Participants will only be able to enroll into this study one time
Informed Consent
Individuals with at least one storage symptom of LUTS presenting to clinics in selected OPD will undergo the informed consent process by principal investigator prior to initiating screening procedures Consent form in Thai language describing in detail the study procedures will be given to the participant privately in a separate room and extensive discussion of risks and possible benefits of participation in this study will be provided Participation will be informed that they may withdraw consent at any time throughout the course of this study
Screening
After documentation of informed consent principal investigator will interview the participant and perform vital signs and physical examination The urinalysis will be performed by urinalysis test strip before the start of the study Screening procedures are as follows
Pelvic exam
Pelvic floor muscle strength measured as Brink scale
Pelvic Organ Prolapse Quantification POP-Q Stress test
Gynecologic ultrasonography with post-void residual volumes PVR
Urinalysis by urinalysis test strip
Bladder diary consecutive three-day diary which the time of each micturition and the volume voided fluid intake incontinence episodes episodes of urgency and sensation will be recorded as might be the activities performed during or immediately preceding the involuntary loss of urine
After screening procedure the appointment will be made for the next visit which is one or two weeks after first visit
Bladder diary
The study will incorporate the use of essential diagnostic tool namely the bladder diary to assess and monitor the outcomes These assessments will be administered under the careful supervision of the study investigators These diagnostic tests play a pivotal role in our research serving as indispensable instruments for evaluating the progression and ultimate success of the treatment interventions
II Second Visit and Randomization
At one or two weeks after 1st visit the following study procedure will be performed
Bladder diary interpretation
ICIQ-FLUTS questionnaire
ICIQ-LUTSqol questionnaire
Vaginal pH
Urethral maturation index UMI
After evaluating all the data collected during the screening process at the initial visit and combining it with the procedures conducted during the second visit if the woman does not meet all study inclusion or if the woman has an exclusion criterion she will not be enrolled into this study A screening log will be kept of all who were evaluated for participation to document who is and is not enrolled and reason for not enrolling in this study
Women who meet inclusion criteria will be randomized with block randomization technique and a ratio of treatments of 11 The sequence generation will be performed under supervision of a senior statistician at the section of Clinical Epidemiology and Biostatistics in Ramathibodi Hospital The random sequences will be generated using Stata version 18 This is an automated process with no interfere from the investigators Upon a subjects successful enrollment in the clinical trial following eligibility assessment principal investigator or research personnel shall provide participants with a comprehensive Thai guidebook for behavior modification which is designed to ensure the harmonization of knowledge and behaviors among all trial participants This guidebook was developed and published by The International Urogynecological Association IUGA and will be distributed by research assistants
Trial Treatment Dosage Form Regimen Route of Administration
17beta-Estradiol 10 mcg Femiest Pharma Munster GMBH Muenster Germany ESTRADIOL HEMIHYDRATE 00103 milligram pH 694
17beta-Estradiol will be administered to group A treatment arm intravaginally The assigned dosage will be one vaginal tablet daily for two weeks then one vaginal tablet twice a week for 10 weeks Participants will be carefully monitored for any changes in clinical condition in each follow-up visits using logbook It is important to clarify that the investigators are not using 17beta-Estradiol Vagifem 25 mcg as the study drug Although 17beta-Estradiol 25 mcg is frequently mentioned in literature reviews and has been historically used for treating vaginal dryness this drug is currently not available in Thailand Therefore the investigators are using 17beta-Estradiol Femiest 10 mcg as an alternative for our study drug Notably 17beta-Estradiol 10 mcg has been shown to provide a therapeutic dose equivalent to that of 17beta-Estradiol 25 mcg for treatment as stated by the FDA This decision ensures that participants receive an effective and appropriate dosage while adhering to the availability of medications in our region
Placebo
Placebo will be administered to group B treatment arms intravaginally The assigned dosage will be one vaginal tablet daily for two weeks then one vaginal tablet twice a week for 10 weeks Participants will be carefully monitored for any changes in clinical condition in each follow-up visits Placebo is produced by Chulalongkorn University Drug and Health Products Innovation Promotion Center Faculty of Pharmaceutical Sciences Chulalongkorn University Details for presentation and packing are as follows
Appearance White round biconvex with E imprint one side
Weight 106 - 110 mg
Hardness 41 - 48 kilopond kp
Thickness 326 - 33 mm
Diameter 602 - 603 mm
Disintegration time 4 min 58sec - 7min 42sec
pH 718
Placebo contains
1 Agglomerated Lactose
2 Microcrystalline cellulose PH 102
3 Magnesium stearate
Both subject groups will be counseled on potential signssymptoms of adverse events and post-marketing experience such as breast pain peripheral edema and postmenopausal bleedings Due to the vaginal administration and minimal systemic absorption it is unlikely that any clinically relevant drug interactions will occur with 17beta-Estradiol However interactions with other locally applied vaginal treatments will be considered and advised to the patients If a dose is forgotten participants will be advised that it should be taken as soon as heshe remembers A double dose should be avoided
Random allocation
Each participant in the study will receive a prescription for the research drug an adequate supply to cover a 12-week treatment duration This drug will be uniformly packaged within identical containers featuring a unique alphanumeric code and detailed usage instructions on the label thereby avoiding the inclusion of the original medication name The data analysis will be performed by a statistician who will be the sole individual privy to the allocation of drug A or drug B to their respective groups It is essential to note that the statistician will remain unaware of which of the two is the active drug and which is the placebo Additionally an independent statistician will maintain a sealed randomization list as a contingency Allocation will be as follows
Group A 17beta-Estradiol 10 mcg Femiest Haupt Pharma Munster GMBH Muenster Germany ESTRADIOL HEMIHYDRATE 00103 milligram
Group B Placebo
III Third Visit
At four weeks after 2nd visit the following study procedure will be performed
Bladder diary the participant will be reminded to provide a three-day diary prior to schedule visit date
ICIQ-FLUTS questionnaire
ICIQ-LUTSqol questionnaire
PGI-I score
Vaginal pH
Urethral maturation index UMI
Participants will also have clinical evaluation and vital signs measurements evaluated Compensation for participants will be provided
IV Fourth and Final Visit
At eight weeks after 3rd visit the following study procedure will be performed
Pelvic exam
Pelvic floor muscle strength measured as Brink scale
Bladder diary the participant will be reminded to provide a three-day diary prior to schedule visit date
ICIQ-FLUTS questionnaire
ICIQ-LUTSqol questionnaire
PGI-I score
Vaginal pH
Urethral maturation index UMI
Participants will also have clinical evaluation and vital signs measurements evaluated Compensation for participants will be provided
Participants will be recruited from the urogynecology clinic menopause clinic and urology clinic using hospital and public advertisement An information sheet in Thai language will be provided to health care providers in the designated outpatient department OPD which can ensure the providers convey the correct study information to potential participant Participants will only be able to enroll into this study one time
Informed Consent
Individuals with at least one storage symptom of LUTS presenting to clinics in selected OPD will undergo the informed consent process by principal investigator prior to initiating screening procedures Consent form in Thai language describing in detail the study procedures will be given to the participant privately in a separate room and extensive discussion of risks and possible benefits of participation in this study will be provided Participation will be informed that they may withdraw consent at any time throughout the course of this study
Screening
After documentation of informed consent principal investigator will interview the participant and perform vital signs and physical examination The urinalysis will be performed by urinalysis test strip before the start of the study Screening procedures are as follows
Pelvic exam
Pelvic floor muscle strength measured as Brink scale
Pelvic Organ Prolapse Quantification POP-Q Stress test
Gynecologic ultrasonography with post-void residual volumes PVR
Urinalysis by urinalysis test strip
Bladder diary consecutive three-day diary which the time of each micturition and the volume voided fluid intake incontinence episodes episodes of urgency and sensation will be recorded as might be the activities performed during or immediately preceding the involuntary loss of urine
After screening procedure the appointment will be made for the next visit which is one or two weeks after first visit
Bladder diary
The study will incorporate the use of essential diagnostic tool namely the bladder diary to assess and monitor the outcomes These assessments will be administered under the careful supervision of the study investigators These diagnostic tests play a pivotal role in our research serving as indispensable instruments for evaluating the progression and ultimate success of the treatment interventions
II Second Visit and Randomization
At one or two weeks after 1st visit the following study procedure will be performed
Bladder diary interpretation
ICIQ-FLUTS questionnaire
ICIQ-LUTSqol questionnaire
Vaginal pH
Urethral maturation index UMI
After evaluating all the data collected during the screening process at the initial visit and combining it with the procedures conducted during the second visit if the woman does not meet all study inclusion or if the woman has an exclusion criterion she will not be enrolled into this study A screening log will be kept of all who were evaluated for participation to document who is and is not enrolled and reason for not enrolling in this study
Women who meet inclusion criteria will be randomized with block randomization technique and a ratio of treatments of 11 The sequence generation will be performed under supervision of a senior statistician at the section of Clinical Epidemiology and Biostatistics in Ramathibodi Hospital The random sequences will be generated using Stata version 18 This is an automated process with no interfere from the investigators Upon a subjects successful enrollment in the clinical trial following eligibility assessment principal investigator or research personnel shall provide participants with a comprehensive Thai guidebook for behavior modification which is designed to ensure the harmonization of knowledge and behaviors among all trial participants This guidebook was developed and published by The International Urogynecological Association IUGA and will be distributed by research assistants
Trial Treatment Dosage Form Regimen Route of Administration
17beta-Estradiol 10 mcg Femiest Pharma Munster GMBH Muenster Germany ESTRADIOL HEMIHYDRATE 00103 milligram pH 694
17beta-Estradiol will be administered to group A treatment arm intravaginally The assigned dosage will be one vaginal tablet daily for two weeks then one vaginal tablet twice a week for 10 weeks Participants will be carefully monitored for any changes in clinical condition in each follow-up visits using logbook It is important to clarify that the investigators are not using 17beta-Estradiol Vagifem 25 mcg as the study drug Although 17beta-Estradiol 25 mcg is frequently mentioned in literature reviews and has been historically used for treating vaginal dryness this drug is currently not available in Thailand Therefore the investigators are using 17beta-Estradiol Femiest 10 mcg as an alternative for our study drug Notably 17beta-Estradiol 10 mcg has been shown to provide a therapeutic dose equivalent to that of 17beta-Estradiol 25 mcg for treatment as stated by the FDA This decision ensures that participants receive an effective and appropriate dosage while adhering to the availability of medications in our region
Placebo
Placebo will be administered to group B treatment arms intravaginally The assigned dosage will be one vaginal tablet daily for two weeks then one vaginal tablet twice a week for 10 weeks Participants will be carefully monitored for any changes in clinical condition in each follow-up visits Placebo is produced by Chulalongkorn University Drug and Health Products Innovation Promotion Center Faculty of Pharmaceutical Sciences Chulalongkorn University Details for presentation and packing are as follows
Appearance White round biconvex with E imprint one side
Weight 106 - 110 mg
Hardness 41 - 48 kilopond kp
Thickness 326 - 33 mm
Diameter 602 - 603 mm
Disintegration time 4 min 58sec - 7min 42sec
pH 718
Placebo contains
1 Agglomerated Lactose
2 Microcrystalline cellulose PH 102
3 Magnesium stearate
Both subject groups will be counseled on potential signssymptoms of adverse events and post-marketing experience such as breast pain peripheral edema and postmenopausal bleedings Due to the vaginal administration and minimal systemic absorption it is unlikely that any clinically relevant drug interactions will occur with 17beta-Estradiol However interactions with other locally applied vaginal treatments will be considered and advised to the patients If a dose is forgotten participants will be advised that it should be taken as soon as heshe remembers A double dose should be avoided
Random allocation
Each participant in the study will receive a prescription for the research drug an adequate supply to cover a 12-week treatment duration This drug will be uniformly packaged within identical containers featuring a unique alphanumeric code and detailed usage instructions on the label thereby avoiding the inclusion of the original medication name The data analysis will be performed by a statistician who will be the sole individual privy to the allocation of drug A or drug B to their respective groups It is essential to note that the statistician will remain unaware of which of the two is the active drug and which is the placebo Additionally an independent statistician will maintain a sealed randomization list as a contingency Allocation will be as follows
Group A 17beta-Estradiol 10 mcg Femiest Haupt Pharma Munster GMBH Muenster Germany ESTRADIOL HEMIHYDRATE 00103 milligram
Group B Placebo
III Third Visit
At four weeks after 2nd visit the following study procedure will be performed
Bladder diary the participant will be reminded to provide a three-day diary prior to schedule visit date
ICIQ-FLUTS questionnaire
ICIQ-LUTSqol questionnaire
PGI-I score
Vaginal pH
Urethral maturation index UMI
Participants will also have clinical evaluation and vital signs measurements evaluated Compensation for participants will be provided
IV Fourth and Final Visit
At eight weeks after 3rd visit the following study procedure will be performed
Pelvic exam
Pelvic floor muscle strength measured as Brink scale
Bladder diary the participant will be reminded to provide a three-day diary prior to schedule visit date
ICIQ-FLUTS questionnaire
ICIQ-LUTSqol questionnaire
PGI-I score
Vaginal pH
Urethral maturation index UMI
Participants will also have clinical evaluation and vital signs measurements evaluated Compensation for participants will be provided
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None