Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
Mallinckrodt
Dow
Harvard Business School
Baxter

Last Updated: January 25, 2020

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR VAGIFEM

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

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.
>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 VagifemĀ® 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 (VagifemĀ®) 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 VagifemĀ® 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.
>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
Vulvar and Vaginal Atrophy 1
Atrophic Vaginitis 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for Vagifem
Intervention Trials
Atrophy 7
Vaginitis 6
Atrophic Vaginitis 6
Breast Neoplasms 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for Vagifem
Location Trials
New Jersey 4
New York 3
Washington 3
Ohio 3
Colorado 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for Vagifem
Clinical Trial Phase Trials
Completed 6
Recruiting 2
Active, not recruiting 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for Vagifem

Sponsor Name

Sponsor Name for Vagifem
Sponsor Trials
Novo Nordisk A/S 4
University of Arizona 1
University of Washington 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for Vagifem
Sponsor Trials
Other 10
Industry 7
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Dow
Mallinckrodt
Medtronic
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.