Vaginal Atrophy, Vulvar Atrophy
Conditions
Keywords
Estradiol, Vulvar atrophy, vaginal atrophy
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.
Interventions
DRUGEstradiol
one tablet will be inserted daily for 14 days
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal pH | 14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of vulvar and vaginal atrophy | 14 days | 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 |
Countries
India
Outcome results
None listed