CLINICAL TRIALS PROFILE FOR VAGIFEM
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505(b)(2) Clinical Trials for vagifem
| 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. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >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 | 1994-08-31 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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