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

This study has been completed.

First Received: February 2, 2007 Last Updated: December 1, 2008 History of Changes

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

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

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

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:

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 ]

Enrollment:	335
Study Start Date:	January 2007
Study Completion Date:	November 2008
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

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Czech Republic

Prague, Czech Republic
Denmark

Glostrup, Denmark, 2600
Finland

Turku, Finland, 20100
France

PARIS, France, 75017
Hungary

Budapest, Hungary
Norway

Trondheim, Norway, NO-7012
Sweden

Uppsala, Sweden

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Michaela Eugster-Hausmann, MD

Novo Nordisk FemCare AG

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	VAG-1748, EudraCT No: 2006-001629-24
Study First Received:	February 2, 2007
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00431132 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Denmark: Danish Medicines Agency; Hungary: National Institute of Pharmacy; Finland: Finnish Medicines Agency; Czech Republic: State Institute for Drug Control; Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 08, 2010