Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

This study has been completed.

First Received: April 19, 2005 Last Updated: June 12, 2009 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00108849

Purpose

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.

Condition	Intervention	Phase
Vaginitis	Drug: intravaginal estradiol	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	309
Study Start Date:	March 2005
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: - Postmenopausal women = 2 years after last menstruation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108849

Locations

United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89103

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Alan Moses, MD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	VAG-2195
Study First Received:	April 19, 2005
Last Updated:	June 12, 2009
ClinicalTrials.gov Identifier:	NCT00108849 History of Changes
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by Novo Nordisk:

vaginitis
atrophic vaginitis

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Genital Diseases, Female
Estradiol 3-benzoate
Estradiol valerate
Vaginitis

Vaginal Diseases
Atrophy
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Genital Diseases, Female
Vaginitis
Vaginal Diseases
Atrophy

ClinicalTrials.gov processed this record on July 02, 2009