Endometrial Safety of Vagifem Low Dose in Postmenopausal Women With Atrophic Vaginitis - Full Text View

Purpose

This trial is conducted in Europe.

The purpose of this study is to evaluate endometrial safety of Vagifem Low dose in healthy postmenopausal women having atropic vaginitis.

Condition	Intervention	Phase
Atrophic Vaginitis	Drug: intravaginal estradiol	Phase III

Drug Information available for:

Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	Endometrial Safety of Vagifem Low Dose in Postmenopausal Women With Atrophic Vaginitis

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Endometrial hyperplasia rate based on histological assessment of endometrial biopsies [ Time Frame: taken at the end of 12 months of treatment with Vagifem Low dose compared to baseline ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Estimated Enrollment:	325
Study Start Date:	January 2007
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: intravaginal estradiol Tablets, 10 mcg adminstered intravaginally twice weekly.

Eligibility

Criteria

Inclusion Criteria:

Postmenopausal women whose last menstruation was at least two years previously
At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity
Generally healthy

Exclusion Criteria:

Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431132

Locations

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Michaela Eugster-Hausmann, MD	Novo Nordisk FemCare AG

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	VAG-1748, EudraCT No: 2006-001629-24
First Received:	February 2, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00431132
Health Authority:	France: Afssaps - French Health Products Safety Agency; Denmark: Danish Medicines Agency; Hungary: National Institute of Pharmacy; Finland: National Agency for Medicines; Czech Republic: State Institute for Drug Control; Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00431132