Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT00108849

First received: April 19, 2005

Last updated: February 6, 2017

Last verified: February 2017

History of Changes

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Vaginitis

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:

Clinical symptoms [ Time Frame: after 12 months ]

Secondary Outcome Measures:

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


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 (Adult, Senior)
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

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: 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:

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
Study First Received:	April 19, 2005
Last Updated:	February 6, 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

ClinicalTrials.gov processed this record on June 23, 2017

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