Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms
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| ClinicalTrials.gov Identifier: NCT00108849 |
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Recruitment Status
:
Completed
First Posted
: April 20, 2005
Last Update Posted
: February 8, 2017
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Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
- Study Details
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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 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
Primary Outcome Measures
:
- Clinical symptoms [ Time Frame: after 12 months ]
Secondary Outcome Measures
:
- Objective parameters (vaginal Maturation Index/Value and vaginal pH)
- Hyperplasia rate
Information from the National Library of Medicine
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| 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
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 |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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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 |