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Efficacy and Safety Of Spil's Estradiol Vaginal Tablet

This study is currently recruiting participants.
Verified December 2012 by Sun Pharmaceutical Industries Limited
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier:
NCT01753102
First received: December 15, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Vulvar Atrophy
Vaginal Atrophy
 Drug: Estradiol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Pharmaceutical Industries Limited:

Primary Outcome Measures:
  • Vaginal pH [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms of vulvar and vaginal atrophy [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 405
Study Start Date: December 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Estradiol
Intravaginal self-administration of study medication once daily for 14 days.
 Drug: Estradiol
one tablet will be inserted daily for 14 days
Other Name: Vagifem
Active Comparator: Reference: Estradiol
Intravaginal self-administration of study medication once daily for 14 days.
 Drug: Estradiol
one tablet will be inserted daily for 14 days
Other Name: Vagifem
Placebo Comparator: Placebo
Intravaginal self-administration of study medication once daily for 14 days.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Postmenopausal woman (defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy 2.At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy, 3. ≤ 5% superficial cells on vaginal smear cytology, 4. Vaginal pH > 5.0

Exclusion Criteria:

  1. Taking estrogen alone or estrogen/progestin containing drug products. (Washout periods recommended before baseline assessments for subjects previously on estrogen alone or estrogen/progestin containing products as in Section 6.2.2)
  2. Known or suspected allergy to estradiol or related products
  3. Known, suspected or past history of breast cancer
  4. Abnormal genital bleeding
  5. History of significant risk factors for endometrial cancer
  6. Use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive sponges, douches, vaginal moisturizers, or other non-oestrogenic medications including K-Y jelly etc., 1 month prior to first planned drug administration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753102

Contacts
Contact: Atul Raut, MD, PhD 91 22 66455645 ext 752

Locations
India
Biniwale Clinic Pvt. Ltd, Recruiting
Pune, Maharashtra, India, 411004
Sponsors and Collaborators
Sun Pharmaceutical Industries Limited
  More Information

No publications provided

Responsible Party: Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier: NCT01753102     History of Changes
Other Study ID Numbers: CLR_10_19, CTRI/2012/09/002983
Study First Received: December 15, 2012
Last Updated: December 19, 2012
Health Authority: India: Drugs Controller General of India

Keywords provided by Sun Pharmaceutical Industries Limited:
Estradiol
Vulvar atrophy
vaginal atrophy

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on May 19, 2013