Endometrial Safety of a Low Dose of Vagifem® 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 intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

Condition	Intervention	Phase
Menopause Postmenopausal Vaginal Atrophy	Drug: estradiol, 10 mcg	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol cypionate Estradiol valerate Estradiol acetate Estradiol hemihydrate

U.S. FDA Resources

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:

Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.

Secondary Outcome Measures:

Transvaginal Ultrasound: Endometrial Thickness [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial.


Enrollment:	336
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
Experimental: Vagifem® 10 mcg One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks	Drug: estradiol, 10 mcg Tablets, administered 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 prior to the time of screening
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 75015
Hungary

Budapest, Hungary
Norway

Trondheim, Norway, NO-7012
Sweden

Uppsala, Sweden

Sponsors and Collaborators

Novo Nordisk A/S

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 by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Simon J, Nachtigall L, Ulrich LG, Eugster-Hausmann M, Gut R. Endometrial safety of ultra-low-dose estradiol vaginal tablets. Obstet Gynecol. 2010 Oct;116(4):876-83. doi: 10.1097/AOG.0b013e3181f386bb.


Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00431132 History of Changes
Other Study ID Numbers:	VAG-1748, 2006-001629-24
Study First Received:	February 2, 2007
Results First Received:	February 7, 2011
Last Updated:	March 19, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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:


Atrophic Vaginitis Genital Diseases, Female Vaginal Diseases Vaginitis

ClinicalTrials.gov processed this record on March 03, 2015