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CTRI Number  CTRI/2020/03/023903 [Registered on: 12/03/2020] Trial Registered Prospectively
Last Modified On: 12/02/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Genitourinary syndrome of menopause and its relief with estriol over 3 months 
Scientific Title of Study   A cohort study on Genitourinary syndrome of menopause and its relief with estriol over 3 months 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajesh Kumari 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Dept of Obstetrics and gynaecology III floor teaching block AIIMS new delhi

New Delhi
DELHI
110029
India 
Phone  9911226176  
Fax    
Email  drrajeshkumari@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Kumari 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Dept of Obstetrics and gynaecology III floor teaching block AIIMS new delhi

New Delhi
DELHI
110029
India 
Phone  9911226176  
Fax    
Email  drrajeshkumari@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Kumari 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Dept of Obstetrics and gynaecology III floor teaching block AIIMS new delhi

New Delhi
DELHI
110029
India 
Phone  9911226176  
Fax    
Email  drrajeshkumari@yahoo.com  
 
Source of Monetary or Material Support  
AIIMS Research Institute 
 
Primary Sponsor  
Name  AIIMS Research Institute 
Address  Ansari Nagar New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajesh Kumari  All India Institute of Medical Sciences New Delhi  Out patient department Department of Obstetrics and Gynaecology, AIIMS, New Delhi
New Delhi
DELHI 
9911226176

drrajeshkumari@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Sexual active women with sexual activity in the past 4 weeks
2. Women having a recent pap smear in the last 1 year
 
 
ExclusionCriteria 
Details  1. Women on OAB drugs/ or who have undergone some Sui surgery
2. Women with POF
3. Women with surgical menopause
4. Women with an abnormal pap/abnormal endometrial thickness inappropriate for age.
5. Women with vaginal infections/ contact allergy/irritation
6. Women with vulvovaginal/urethral premalignant/ malignant lesions
7. Women with postmenopausal bleeding
8. Women with bilateral oophorectomy/ surgical menopause
9. Women with UTI(Urinary tract infections)
10. Women with history of estrogen dependent tumours
11. Pregnancy/Lactation
12. Women with SLE, Migraine, severe headaches
13. Women with unexplained vaginal bleeding
14. Increased risk of getting an estrogen sensitive cancer such as having a mother, sister or grandmother having a known, past or suspected breast cancer.
15. Women with unexplained vaginal bleeding
16. Women with history of heart attack, stroke, angina, liver disease, porphyria, hypertension, gall stones, diabetes mellitus, epilepsy, asthma or otosclerosis
17. Women with history of any bleeding disorder
18. Women who have received radiotherapy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
use of local vaginal estrogen therapy is assosciated with significant improvement in women’s self-reported prior bothersomeness and improvement in quality of life post treatment  after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/03/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Weber MA, Kleijn MH, Langendam M, Limpens J, Heineman MJ, Roovers JP. Local Oestrogen for Pelvic Floor Disorders: A Systematic Review. PloS One. 2015;10(9):e0136265. 2. Portman DJ, Gass MLS, Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women’s Sexual Health and the North American Menopause Society. Menopause N Y N. 2014 Oct;21(10):1063–8. 3. Dorr MB, Nelson AL, Mayer PR, Ranganath RP, Norris PM, Helzner EC, et al. Plasma estrogen concentrations after oral and vaginal estrogen administration in women with atrophic vaginitis. Fertil Steril. 2010 Nov;94(6):2365–8.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Estrogen levels plummet after menopause, due to declining ovarian function, causing atrophic urogenital symptoms in 1/3 rd of women to the tune of almost as high as 50-60%.The most commonly perceived symptoms are dryness, itching, burning , irritation of vagina, dyspareuniaie pain during intercourse, dysuria, urgency, frequency and recurrent urinary tract infections. They are together called as the Genitourinary syndrome of menopause.(1) Most of the women report them as moderate to severe in severity. In 2014 , this  new terminology was introduced by the International society of women’s sexual health and the North American Menpause Society in replacement of the older term(VVA)ie Vulvar-vaginal atrophy(2) .Vulva, vagina, urethra, bladder and pelvic musculature  conspicuously show changes  with connective tissue thinning,due to estrogen deficiency  due to the presence of estrogen receptors in these tissues.The urinary tract is also affected alongside these vaginal and vulval changes, due to their common embryological origin, causing recurrent urinary tract infections without a positive urine culture due to atrophic urethritis.(1)

The effectiveness of  local application of vaginal estrogen cream for treating urogenital atrophy has been well established  beyond doubt in literature(3). Intravaginal estrogen use is assosciated with relief of  genitourinary symptoms of menopause and improved quality of life with lesser incidence of recurrent urinary tract infections, and incontinence observed with a maximal effect over a period of 12 weeks treatment.(1)

 

Nice guidelines 2015 recommends intravaginal estrogen therapy for  urogenital atrophy  for as long as needed , including in women on  systemic HRT. It’s efficacy and tolerability is to be reviewed every 3 months.It is also recommended to increase the dose of intravaginal estrogen, if the current dose fails to provide adequate relief to the patient. Adverse effects due to local estrogen use are very rare and hence, no routine monitoring of endometrial thickness during treatment has been recommended till date for unopposed low dose estrogen usage.(3,(4)) In the past, systemic HRT use was stressed on upon, for the genitourinary symptoms of menopause, but recently , the interest has shifted upon the local estrogen use due to increased and better efficacy with  delivery of locally applied drug to the target areas with no side effects.(5). Relief of incontinence symptoms  of both Sui and Overactive bladder in menopausal women have been attributed to local estrogen use with statistical supremacy in various studies in literature. Intravaginal estrogen increases urethral coaptation by increasing MUCP, in lieu of increased blood supply due to local estrogen use , reducing Sui symptomatology over 3 months usage(6)Also, frequency of uninhibited uterine contractions and their amplitude are dampened with local estrogen use as estrogen deficiency is an etiological factor in irritated bladder with increased frequency, urgency and nocturia , as its manifestations -according to a Cochrane review, published in 2003, and updated in 200(7). The sensory threshold of bladder is also increased promoting relaxation of the bladder –proving to be very useful in  relieving urge incontinence symptomatology of menopausal  women(8).The use of local vaginal estrogen therapy is assosciated with significant improvement in women’s self-reported prior bothersomeness and improvement in quality of life post treatment.(9)

 

 
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