CLINICAL TRIALS PROFILE FOR VAGIFEM

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	Completed	Group Health Cooperative	Phase 3	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	Completed	Kaiser Permanente	Phase 3	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	Completed	Massachusetts General Hospital	Phase 3	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	Completed	University of California, San Diego	Phase 3	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.

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	1994-08-31	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.

Clinical Trial Conditions for vagifem

Condition Name

Condition Name for vagifem
Intervention	Trials
Menopause	6
Postmenopausal Vaginal Atrophy	4
Vulvovaginal Atrophy	2
Genitourinary Syndrome of Menopause	1

Condition MeSH

Condition MeSH for vagifem
Intervention	Trials
Atrophy	9
Atrophic Vaginitis	6
Vaginitis	6
Breast Neoplasms	3

Clinical Trial Locations for vagifem

Trials by Country

Trials by Country for vagifem
Location	Trials
United States	48
Sweden	2
India	1
Canada	1
Denmark	1

Trials by US State

Trials by US State for vagifem
Location	Trials
Washington	4
New Jersey	4
Ohio	3
New York	3
Florida	2

Clinical Trial Progress for vagifem

Clinical Trial Phase

Clinical Trial Phase for vagifem
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	7
Phase 2	2

Clinical Trial Status

Clinical Trial Status for vagifem
Clinical Trial Phase	Trials
Completed	9
Active, not recruiting	1
Terminated	1

Clinical Trial Sponsors for vagifem

Sponsor Name

Sponsor Name for vagifem
Sponsor	Trials
Novo Nordisk A/S	4
University of Washington	2
University of Minnesota	1

Sponsor Type

Sponsor Type for vagifem
Sponsor	Trials
Other	15
Industry	7