NCT01753102

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2013

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

December 15, 2012

Last Update Submit

October 6, 2018

Conditions

Vulvar AtrophyVaginal Atrophy

Keywords

EstradiolVulvar atrophyvaginal atrophy

Outcome Measures

Primary Outcomes (1)

  • Vaginal pH

    14 days

Secondary Outcomes (1)

  • Symptoms of vulvar and vaginal atrophy

    14 days

Study Arms (3)

Estradiol

EXPERIMENTAL

Intravaginal self-administration of study medication once daily for 14 days.

Drug: Estradiol

Reference: Estradiol

ACTIVE COMPARATOR

Intravaginal self-administration of study medication once daily for 14 days.

Drug: Estradiol

Placebo

PLACEBO COMPARATOR

Intravaginal self-administration of study medication once daily for 14 days.

Drug: Estradiol

Interventions

EstradiolDRUG

one tablet will be inserted daily for 14 days

Also known as: Vagifem
EstradiolPlaceboReference: Estradiol

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biniwale Clinic Pvt. Ltd,

Pune, Maharashtra, 411004, India

Location

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2012

First Posted

December 20, 2012

Study Start

November 6, 2012

Primary Completion

April 30, 2013

Study Completion

April 30, 2013

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

IN(1)