Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
Launched by SUN PHARMACEUTICAL INDUSTRIES LIMITED · Dec 19, 2012
Trial Information
Current as of April 25, 2025
Terminated
Keywords
ClinConnect Summary
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.
Gender
FEMALE
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
About Sun Pharmaceutical Industries Limited
Sun Pharmaceutical Industries Limited is a leading global pharmaceutical company headquartered in India, renowned for its commitment to innovation and excellence in the development of high-quality generic and specialty medications. With a strong focus on research and development, Sun Pharma operates across multiple therapeutic areas, including psychiatry, neurology, cardiology, and oncology. The company leverages advanced technologies and a robust global infrastructure to deliver affordable healthcare solutions, while adhering to the highest regulatory standards. Through its dedication to clinical trials and partnerships, Sun Pharma aims to enhance patient outcomes and expand access to essential medicines worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pune, Maharashtra, India
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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