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Last Updated: November 26, 2020

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CLINICAL TRIALS PROFILE FOR VAGIFEM

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505(b)(2) Clinical Trials for Vagifem

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT02516202 The Vaginal Health Trial Recruiting Group Health Cooperative Phase 4 2016-04-01 This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
OTC NCT02516202 The Vaginal Health Trial Recruiting Kaiser Permanente Phase 4 2016-04-01 This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
OTC NCT02516202 The Vaginal Health Trial Recruiting Massachusetts General Hospital Phase 4 2016-04-01 This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
OTC NCT02516202 The Vaginal Health Trial Recruiting University of California, San Diego Phase 4 2016-04-01 This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
OTC NCT02516202 The Vaginal Health Trial Recruiting University of Minnesota, MN Phase 4 2016-04-01 This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
OTC NCT02516202 The Vaginal Health Trial Recruiting University of Washington Phase 4 2016-04-01 This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
OTC NCT02516202 The Vaginal Health Trial Recruiting Fred Hutchinson Cancer Research Center Phase 4 2016-04-01 This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Vagifem

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00108849 Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms Completed Novo Nordisk A/S Phase 3 2005-03-01 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 2007-01-01 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 1994-08-01 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 2009-09-01 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 2006-04-01 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.
NCT01753102 Efficacy and Safety Of Spil's Estradiol Vaginal Tablet Terminated Sun Pharmaceutical Industries Limited Phase 3 2012-11-01 Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol. The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen. The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is approved and marketed in the US.
NCT01779947 Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo Completed Amneal Pharmaceuticals, LLC Phase 3 2012-03-01 The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the efficacy of each of the 2 active treatments is superior to that of the placebo.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Vagifem

Condition Name

Condition Name for Vagifem
Intervention Trials
Menopause 6
Postmenopausal Vaginal Atrophy 4
Atrophy of Vagina 1
Pelvic Floor Disorders 1
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Condition MeSH

Condition MeSH for Vagifem
Intervention Trials
Atrophy 7
Vaginitis 6
Atrophic 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
Finland 1
Norway 1
India 1
Canada 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
Arizona 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
Sun Pharmaceutical Industries Limited 1
University of California, San Diego 1
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Sponsor Type

Sponsor Type for Vagifem
Sponsor Trials
Other 10
Industry 7
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