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| Name | Class |
|---|---|
| University of Utah | OTHER |
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This is a pilot study, assessing the ability and safety of the use of VR101 intravaginal ring to relieve the symptoms of vaginal dryness, in peri and post-menopausal women. VR1010 is designed to release glycerol. The study will assess the duration of lubrication/ moisturization of the vagina with the VR101 intravaginal ring in place (up to 7 days) and participant satisfaction of the device.
Study participants will insert the intravaginal ring and leave it in place for an initial 7 days and then repeat this process a 2nd time. Participants will respond to questionnaires, complete a daily diary and come in for 4 separate study visits. Each study visit will involve a brief vaginal exam.
Upon removal of the initially inserted device (7 days after first study visit), participants will insert a second device for an additional 7 days and undergo the same evaluation.
Vaginal dryness affects many women, although they frequently do not bring up the topic with their doctors. Vaginal dryness can dramatically affect women's lifestyle, in particular their sexual activity and relationship with their partner. Since we believe that living with uncomfortable vaginal dryness does not have to be part of aging, we intend to conduct this study to evaluate a lubricating vaginal ring developed to ease symptoms caused by vaginal dryness.
The objectives of this study are to obtain preliminary data on the ability of the VR101 intravaginal ring to relieve the symptoms of vaginal dryness in peri- and post-menopausal women. Effectiveness will be measured in two ways:
Study objectives will assess the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Study | Other | Vaginal Lubrication Ring for Vaginal Dryness |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Lubrication Ring for Vaginal Dryness | Device | Participants will be asked to complete 4 study visits and one final follow-up phone call. Each study visit will include a brief vaginal exam where vaginal fluid levels and pH levels are checked and questionnaires are completed. Daily diaries will be completed at home and returned to the study staff at subsequent visits. Participants will self-insert the Intravaginal ring on the 1st study visit. The 2nd study visit will occur 3-4 days later. The 3rd study visit will occur approximately 7 days after the 1st visit. Participants will remove the device and self-insert a new intravaginal ring. The 4th study visit will occur approximately 14 days after the first visit. Participants will remove the intravaginal ring and undergo a final vaginal exam. Participants will be called approximately 7 days after the last visit and will be asked about their current vaginal dryness symptoms and how they felt about the device during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal lubrication/moisturization | Assessment of patient reported vaginal lubrication/moisturization while the intravaginal ring is inserted. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort and fit of intravaginal ring | Assessment of patient satisfaction with the comfort and fit of the intravaginal ring during the study period. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Successful vaginal placement and removal | Assessment of patient ability to self-insert and self-remove the intravaginal ring at the initial study visit as well as throughout the 14 day time period of the study. | 14 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margit Janat-Amsbury, MD, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19493638 | Background | Palacios S. Managing urogenital atrophy. Maturitas. 2009 Aug 20;63(4):315-8. doi: 10.1016/j.maturitas.2009.04.009. Epub 2009 Jun 2. | |
| 23133861 | Background | Vaginal atrophy. Managing vaginal dryness and irritation. Mayo Clin Health Lett. 2012 Oct;30(10):6. No abstract available. |
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| ID | Term |
|---|---|
| D059268 | Atrophic Vaginitis |
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| 23253575 | Background | Woods NF. An overview of chronic vaginal atrophy and options for symptom management. Nurs Womens Health. 2012 Dec;16(6):482-93; quiz 494. doi: 10.1111/j.1751-486X.2012.01776.x. |
| 21672177 | Background | Andelloux M. Products for sexual lubrication: understanding and addressing options with your patients. Nurs Womens Health. 2011 Jun-Jul;15(3):253-7. doi: 10.1111/j.1751-486X.2011.01642.x. No abstract available. |
| 20608584 | Background | Bond S, Horton LS. Management of postmenopausal vaginal symptoms in women. J Gerontol Nurs. 2010 Jul;36(7):3-7. doi: 10.3928/00989134-20100527-96. Epub 2010 Jul 8. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |