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
|
|
Primary Sponsor
|
Name |
AIIMS Research Institute |
Address |
Ansari Nagar New Delhi |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
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
|
|
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
|
|
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)
|