Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

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ClinicalTrials.gov Identifier: NCT00108849

Recruitment Status : Completed

First Posted : April 20, 2005

Last Update Posted : February 8, 2017

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk A/S

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Menopause Postmenopausal Vaginal Atrophy	Drug: estradiol, 10 mcg	Phase 3

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	309 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A 12 Month Double-blind, Randomized, Parallel-group, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet) for the Treatment of Postmenopausal Atrophic Vaginitis Symptoms
Study Start Date :	March 2005
Actual Primary Completion Date :	May 2007
Actual Study Completion Date :	May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

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

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Clinical symptoms [ Time Frame: after 12 months ]

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	45 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal women whose last menstruation was at least two years previously

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108849

Show 57 Study Locations

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

Additional Information:

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

Publications of Results:

Mettler L, Olsen PG. Long-term treatment of atrophic vaginitis with low-dose oestradiol vaginal tablets. Maturitas. 1991 Dec;14(1):23-31.

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.

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. doi: 10.1097/AOG.0b013e31818aa7c3. Erratum in: Obstet Gynecol. 2008 Dec;112(6):1392.


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00108849 History of Changes
Other Study ID Numbers:	VAG-2195
First Posted:	April 20, 2005 Key Record Dates
Last Update Posted:	February 8, 2017
Last Verified:	February 2017

Additional relevant MeSH terms:


Atrophy Vaginitis Atrophic Vaginitis Pathological Conditions, Anatomical Vaginal Diseases Genital Diseases, Female Estradiol Polyestradiol phosphate Estradiol 3-benzoate	Estradiol 17 beta-cypionate Estradiol valerate Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female

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