1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [parulagrawal1999@gmail.com].
   


6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

A randomized study on Comparative study of vaginal conjugated estrogen and vaginal estriol for relief of symptoms in genitourinary syndrome of menopause (GSM)will be conducted in the department of Obstetrics and Gynaecology ABVIMS Dr. RML Hospital. The patients will be recruited from Menopausal Outpatient Department who are presenting with symptoms of genitourinary syndrome of menopause that includes genital symptoms (such as dryness burning and irritation) sexual symptoms (such as lack of lubrication discomfort or pain) and urinary symptoms (such as urgency dysuria and recurrent urinary tract infections). The patients would be screened for inclusion and exclusion criteria and 30 postmenopausal women would be enrolled. Each participant will be explained the study details and a written informed consent will be obtained in each’s own understandable language. The following variables of enrolled patients would be noted Age of the patient at the time of enrollment age at menopause Duration since menopause severity and duration of genitourinary symptoms sexual activity and associated comorbidities like Hypertension and Diabetes. A self-assessment questionnaire of GSM symptoms would be administered by patients who had one or more of the symptoms and it consists of questions about the severity of GSM symptoms. Each woman would be asked to describe the GSM symptom which had the greatest influence on her quality of life and it would be rated as the Most Bothersome symptom (MBS). A self designed self administered Likert scale will be used to assess most bothersome symptom (MBS) on a scale of 0 to 5 where 0- not at all bothered 1 somewhat bothered 2 can’t say 3 Quite a bit 4 Extremely Bothered. Score will be noted and considered as the baseline value. 

Patients will then undergo detailed physical examination including breast examination local examination Per speculum and per vaginum examination.

Vaginal pH and vaginal smear will be taken for objective assessment of GSM. All the subjects will undergo sterile speculum examination. Vaginal pH level was measured by pH indicator paper with colour scale which range from pH 2 to 10.5. The paper was contacted to the right lateral mid third vagina for 5 seconds and the colour is compared with colour scale and thus pH value is determined. The VMI Vaginal maturation index will be determined by obtaining a brush sample from the upper 1/3rd lateral vaginal wall and placing it in a standard BD SurePath™ Liquid- based Pap Test container. The samples will be stained with Papanicolaou stain for cell visualisation and read by a cytopathology expert  estimating the proportions of parabasal intermediate and superficial cells based on a 100 cell-count representation. Parabasal cells are small rounded cells with large nuclei comprising 50-70% of the total cell size. Intermediate cells have small nuclei with round cells. Superficial cells have smaller nuclei rectangular cell membranes with abundant cytoplasm with the nucleus comprising 10-20% of the cell. Superficial cells intermediate cells and parabasal cells were assigned a point value of 1 0.5 and 0 respectively. The number of cells in each category will be multiplied by point values and all three results will be added  to the total score of VMI .  A predominance of parabasal and the absence of superficial cells indicate low estrogen levels. The smear will be considered atrophic if the percentage of superficial cells is  less than 5 percent. Patients will be alternatively allocated into two treatment regimes( Group A and group B). The first eligible patient will be assigned to the Conjugated estrogen group second to the Estriol group third again to the Conjugated estrogen group and so on in consecutive alternating sequence. This approach ensured  balanced distribution of participants between the two groups throughout the enrollment period.

Group A will be prescribed vaginal conjugated estrogen once daily  for 4 weeks  and Group B will be prescribed vaginal estriol applied once daily for 4 weeks. 

Patients will be asked to come at 15 days for reassessment of symptoms and for any side effects. Patients would then be asked to report at the end of 1 month of treatment for reassessment of symptoms and outcome would be measured. 

Primary outcome- Improvement in symptoms

Secondary outcome- Improvement in pH  VMI and recurrence of symptoms at 3 month

At this time vaginal  pH and VMI would be measured again.

The patients will be followed up at the end of 3 months since initial visit to check for recurrence if any. The results thus obtained will be subjected to statistical analysis.