Back to resultsEfficacy and Safety Of Spil's Estradiol Vaginal Tablet
Primary Purpose
Vulvar Atrophy, Vaginal Atrophy
Status
Terminated
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Estradiol
Sponsored by
About this trial
This is an interventional treatment trial for Vulvar Atrophy focused on measuring Estradiol, Vulvar atrophy, vaginal atrophy
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal woman
- At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy
- ≤ 5% superficial cells on vaginal smear cytology
- Vaginal pH > 5.0
Exclusion Criteria:
- Consumption of estrogen alone or estrogen/progestin containing drug products.
- Allergy to estradiol or related products
- History of breast cancer and significant risk factors for endometrial cancer
- Abnormal genital bleeding
Sites / Locations
- Biniwale Clinic Pvt. Ltd,
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Estradiol
Reference: Estradiol
Placebo
Arm Description
Intravaginal self-administration of study medication once daily for 14 days.
Intravaginal self-administration of study medication once daily for 14 days.
Intravaginal self-administration of study medication once daily for 14 days.
Outcomes
Primary Outcome Measures
Vaginal pH
Secondary Outcome Measures
Symptoms of vulvar and vaginal atrophy
Each subject will specify identified most bothersome symptoms vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity, vaginal bleeding associated with sexual activity) and self-evaluate the symptom on a pre-defined scale
Full Information
NCT ID
NCT01753102
First Posted
December 15, 2012
Last Updated
October 6, 2018
Sponsor
Sun Pharmaceutical Industries Limited
1. Study Identification
Unique Protocol Identification Number
NCT01753102
Brief Title
Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
Official Title
EFFICACY AND SAFETY OF SPIL'S ESTRADIOL VAGINAL TABLET, 10 MCG ESTRADIOL IN SUBJECTS WITH VULVAR AND VAGINAL ATROPHY: A RANDOMIZED, OBSERVER BLIND, PARALLEL GROUPS, ACTIVE AND PLACEBO CONTROLLED, CLINICAL ENDPOINT BIOEQUIVALENCE STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
November 6, 2012 (Actual)
Primary Completion Date
April 30, 2013 (Actual)
Study Completion Date
April 30, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol.
The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen.
The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is approved and marketed in the US.
Detailed Description
Estradiol vaginal tablet is indicated for use in the treatment of symptoms of atrophic vaginitis due to estrogen deficiency.
This is a randomized, observer blind, parallel groups, active and placebo controlled study to test the clinical endpoint bioequivalence of test product (Estradiol vaginal tablet, 10mcg of Sun Pharmaceutical Industries Ltd. India) relative to reference (Vagifem®, Estradiol vaginal tablet, 10mcg estradiol of Novo Nordisk) in treatment of vulvar and vaginal atrophy.
The patients will be administered with one tablet intravaginally daily for 14 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Atrophy, Vaginal Atrophy
Keywords
Estradiol, Vulvar atrophy, vaginal atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Estradiol
Arm Type
Experimental
Arm Description
Intravaginal self-administration of study medication once daily for 14 days.
Arm Title
Reference: Estradiol
Arm Type
Active Comparator
Arm Description
Intravaginal self-administration of study medication once daily for 14 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravaginal self-administration of study medication once daily for 14 days.
Intervention Type
Drug
Intervention Name(s)
Estradiol
Other Intervention Name(s)
Vagifem
Intervention Description
one tablet will be inserted daily for 14 days
Primary Outcome Measure Information:
Title
Vaginal pH
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Symptoms of vulvar and vaginal atrophy
Description
Each subject will specify identified most bothersome symptoms vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity, vaginal bleeding associated with sexual activity) and self-evaluate the symptom on a pre-defined scale
Time Frame
14 days
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Postmenopausal woman
At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy
≤ 5% superficial cells on vaginal smear cytology
Vaginal pH > 5.0
Exclusion Criteria:
Consumption of estrogen alone or estrogen/progestin containing drug products.
Allergy to estradiol or related products
History of breast cancer and significant risk factors for endometrial cancer
Abnormal genital bleeding
Facility Information:
Facility Name
Biniwale Clinic Pvt. Ltd,
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
We'll reach out to this number within 24 hrs