Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms - Tabular View

Tracking Information

First Received Date ^ICMJE

April 19, 2005

Last Updated Date

June 12, 2009

Start Date ^ICMJE

March 2005

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical symptoms [ Time Frame: after 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Clinical symptoms after 12 months

Change History

Complete list of historical versions of study NCT00108849 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Objective parameters (vaginal Maturation Index/Value and vaginal pH) [ Designated as safety issue: No ]
Hyperplasia rate [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Objective parameters (vaginal Maturation Index/Value and vaginal pH)
Hyperplasia rate

Descriptive Information

Brief Title ^ICMJE

Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

Official Title ^ICMJE

Efficacy and Safety of Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

Brief Summary

This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Vaginitis

Intervention ^ICMJE

Drug: intravaginal estradiol

Study Arms / Comparison Groups

Publications *

Simon J, Nachtigall L, Gut R, Lang E, Archer DF, Utian W. Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. Obstet Gynecol. 2008 Nov;112(5):1053-60.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

309

Completion Date

May 2007

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Postmenopausal women = 2 years after last menstruation

Gender

Female

Ages

45 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00108849

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

VAG-2195

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Alan Moses, MD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP