Status:
COMPLETED
Efficacy of VR101 as a Personal Lubricant
Lead Sponsor:
J3 Bioscience, Inc.
Collaborating Sponsors:
Advanced Clinical Research Services, LLC
Conditions:
Sexual Dysfunction, Physiological
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
This Clinical Investigation (CI03) is designed to validate the efficacy of the VR101 lubricating Intravaginal Ring (IVR) as a personal lubricant device. In the proposed clinical investigation, partici...
Detailed Description
BACKGROUND This study will look at the use of a study device that is intended to provide moisture and lubrication to enhance the ease and comfort of intimate sexual activity and supplement the body's ...
Eligibility Criteria
Inclusion
- Inclusion Criteria: Clinical Investigation Participants Must:
- Completely understand and sign the informed consent form (ability to read and understand the consent form in the English language).
- Be at least 21 years of age.
- Express a willingness to comply with the entire study visit schedule outlined in the protocol.
- Over the course of the study:
- Abstain from the use of any vaginal moisturizers or lubricants or any other topically applied vaginal products not provided by study staff during the entirety of study participation
- Abstain from using lubricated or spermicide-containing male or female condoms
- Abstain from vaginal intercourse with a male partner using a lubricated condom
- Abstain from any oral sex during or prior to vaginal intercourse with a male partner.
- Must not initiate, modify or discontinue a regimen of HRT (hormone replacement therapy) or estrogen-containing birth control.
- NOTE: Women who have been using non-vaginal HRT or estrogen-containing birth control (e.g., oral, transdermal) on a regular dosing interval continuously for at least 3 months may continue on the same regimen during the study
- Abstain from the use of any other vaginally-placed devices (e.g. ring, diaphragm, cervical cap, pessary products)
- If able to get pregnant, use an approved method of contraception (per the remainder of I/E criteria) to reduce their risk of becoming pregnant during the study.
- In the previous 3 months, have had or attempted sexual intercourse with a male partner a minimum of twice per month (on average).
- Respond to all 4 individual FSFI Lubrication Questions (7 - 10) with a score of 1, 2, or 3.
- Attempt sexual intercourse at least 4 times during the 4-week double-blind study.
- Exclusion criteria for participant selection
- Participants self-reporting any of the following will be ineligible for study entry:
- Current use of HRT (Hormone Replacement Therapy) or any estrogen-containing birth control products, unless not applied vaginally and the participant has been on a regular dosing interval for at least 3 months prior and is willing to continue the same regimen without modification throughout study participation.
- Vulvar or vaginal procedures (biopsies, radiation) in the last 3 months.
- Active vulvar or vaginal infections/lesions or complaints, as well as undiagnosed abnormal genital bleeding.
- History of chronic pelvic pain, interstitial cystitis, vulvar vestibulitis, pelvic inflammatory disease within the past 3 months.
- Known current cervical or vaginal infection.
- Participants who have given birth or terminated pregnancy in the past 6 weeks.
- Postpartum or post-abortion endometritis, unless symptoms resolved at least 3 months prior to study entry.
- Current persistent, abnormal vaginal bleeding.
- History of the inability to place a vaginal ring.
- History of any abnormality of the vagina resulting in distortion of the vaginal canal or incompatibility with vaginal ring placement.
- Body habitus or history of lower genital tract abnormalities or prior surgeries, which may not allow the vagina to be appropriately accessed.
- Known or suspected allergy or hypersensitivity to polyurethanes or glycerol.
- Known current alcohol or illicit drug abuse.
- Participants who have not recovered from adverse events due to chemotherapy or radiation treatment for cancer.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the urogenital tract, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any condition that in the opinion of the investigator or study staff that would constitute contraindications to participation in the study or would compromise the ability to comply with the study protocol.
- Current use of a vaginally-placed device (e.g., ring, pessary, cervical cap or diaphragm) unless willingness to discontinue for the study duration is expressed.
- Pregnancy or plans to become pregnant in the next 6 months.
- Current breastfeeding.
- Participation in a previous ViroPan or J3 Bioscience clinical trial for VR101 (i.e., CI01, CI02)
- NOTE: IUD (Intrauterine Device) users may be enrolled provided they commit to exercising caution when removing VR101, as IUD strings have been noted to interfere with VR101 removal.
- NOTE: Participants who have previously undergone anterior and/or posterior vaginal repair and have received a vaginal mesh implant may have difficulty placing VR101 but are not automatically excluded from the study.
Exclusion
Key Trial Info
Start Date :
February 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2020
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT04288752
Start Date
February 26 2020
End Date
May 26 2020
Last Update
August 10 2021
Active Locations (2)
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1
Advanced Clinical Research, Inc. (ACR Idaho)
Meridian, Idaho, United States, 83642
2
Advanced Clinical Research, Inc. (ACR Utah)
West Jordan, Utah, United States, 84088