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Generated: February 23, 2019

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CLINICAL TRIALS PROFILE FOR VAGIFEM

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Clinical Trials for Vagifem

Trial ID Title Status Sponsor Phase Summary
NCT00108849 Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms Completed Novo Nordisk A/S Phase 3 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.
NCT00431132 Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis Completed Novo Nordisk A/S Phase 3 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.
NCT00465192 Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis Completed Novo Nordisk A/S Phase 3 This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.
NCT00984399 Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen Active, not recruiting Memorial Sloan Kettering Cancer Center N/A The purpose of this study is to see if Vagifem® 10mcg is safe for women who have had breast cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina. It relieves vaginal dryness. Women who have had breast cancer are usually told not to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise in your estrogen level. However, there is no clear evidence that this would cause any bad effects in patients with breast cancer. How much, if any, of these topical estrogens are absorbed through the vagina is not known. We also do not know what the impact is of low dose estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as the mucus membranes are restored after estrogen exposure.
NCT01507454 Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency Completed Novo Nordisk A/S N/A This study is conducted in Europe. The aim of this study is to investigate the self-reported impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic vaginitis due to oestrogen deficiency.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Vagifem

Condition Name

Condition Name for Vagifem
Intervention Trials
Menopause 6
Postmenopausal Vaginal Atrophy 4
Vaginal Atrophy 1
Dyspareunia (Female) 1
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Condition MeSH

Condition MeSH for Vagifem
Intervention Trials
Atrophy 7
Atrophic Vaginitis 6
Vaginitis 6
Breast Neoplasms 2
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Clinical Trial Locations for Vagifem

Trials by Country

Trials by Country for Vagifem
Location Trials
United States 45
Canada 1
Denmark 1
Hungary 1
Germany 1
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Trials by US State

Trials by US State for Vagifem
Location Trials
New Jersey 4
Ohio 3
New York 3
Washington 3
Pennsylvania 2
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Clinical Trial Progress for Vagifem

Clinical Trial Phase

Clinical Trial Phase for Vagifem
Clinical Trial Phase Trials
Phase 4 2
Phase 3 6
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Vagifem
Clinical Trial Phase Trials
Completed 6
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for Vagifem

Sponsor Name

Sponsor Name for Vagifem
Sponsor Trials
Novo Nordisk A/S 4
Massachusetts General Hospital 1
University Hospitals Cleveland Medical Center 1
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Sponsor Type

Sponsor Type for Vagifem
Sponsor Trials
Other 10
Industry 7
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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
Argus Health
Healthtrust
Chubb
McKesson
McKinsey
Fish and Richardson
Harvard Business School

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