A Study of the Safety and Acceptability of a Placebo Vaginal Film: FAME101

NCT03537092 | Completed Results FDA Device

• 3 other identifiers: PRO17090024ES-38322U19AI120249
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I randomized trial assessing the safety of a single vaginal placebo film application. In order to develop a vaginal film which can provide extended release of an Antiretroviral (ARV), the film polymers and formulation have been altered from the cellulose and polyvinyl alcohol films used to deliver dapivirine and tenofovir in previous trials. Therefore, the proposed study will evaluate the safety and persistence of these film polymers when applied vaginally.

Conditions

Safety of Vaginal Film Use

Outcome Measures

Primary Outcomes (1)

• Grade 2 or Higher Urogenital System Adverse Event Related to Film Use

  Any urogenital adverse event that occurs with a severity of Grade 2 (moderate) or higher that is deemed to be related to product use by the clinical primary investigator

  30 days

Secondary Outcomes (3)

• Correct Insertion of Vaginal Film

  30 days

• Difficulty of Vaginal Film Insertion

  30 days

• Acceptability of Vaginal Film Use

  30 days

Study Arms (1)

Vaginal Film

EXPERIMENTAL

Each participant who inserted a single use placebo vaginal film (Day 0) is randomized to the timing of Visit 3 (Day 3, 7, 10, or 14)

Device: Vaginal Film

Interventions

Vaginal Film DEVICE

2" x 2" vaginal film with no active drug

Vaginal Film

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: All participants must have a vagina as this is using a vaginal film
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 through 45 years (inclusive) at screening
• Able and willing to provide written informed consent to be screened for and to take part in the study.
• Able and willing to provide adequate locator information
• HIV-uninfected based on testing performed by study staff at screening (per algorithm in Appendix II)
• In general good health as determined by the site clinician
• Agree to be sexually abstinent for 48 hours prior to each visit and from Visit 2 to Visit 3
• At screening, agrees to abstain from any other intravaginal product or penetration (including sex toys, excluding tampons) for 48 hours prior to each visit and between Visit 2 and 3.
• Willingness to undergo all study-related assessments and follow all study-related procedures
• At screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, or vaginal products while enrolled in this trial

You may not qualify if:

• Menopause (as defined as amenorrhea for one year or more without an alternative etiology)
• Hysterectomy
• Participant report of any of the following:
• Known adverse reaction to any of the study products (ever)
• Known adverse reaction to latex (ever)
• Non- therapeutic injection drug use in the 12 months prior to Screening
• Surgical procedure involving the pelvis in the 90 days prior to enrollment (includes dilation and curettage or evacuation, and cryosurgery; does not include cervical biopsy for evaluation of an abnormal pap smear)
• Participation in a drug, spermicide and/or microbicide study in the 30 days prior to enrollment or anticipated participation in an investigational drug study until completion of the study
• Currently pregnant or pregnancy within 42 days prior to enrollment
• Currently lactating
• Use of a diaphragm, NuvaRing®, or spermicide for contraception
• Internal vaginal use of any device or product (except tampons) in the 48 hours prior to enrollment
• Urogenital infection or suspected infection within 14 days of enrollment including: symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis; or cervical infection, including N. gonorrhoeae, C. trachomatis, or mucopurulent cervicitis; syphilis; herpes simplex virus lesions, or other sores (Note: seropositive Herpes simplex virus without active lesions will not be excluded); acute pelvic inflammatory disease; urinary tract infection; recent exposure to a partner with N. gonorrhoeae, C. trachomatis, Trichomonas, syphilis, or nongonococcal urethritis.
• Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment
• As determined by the PI, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease

Sponsors & Collaborators

• Katherine Bunge: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Magee womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Results Point of Contact

• Title: Leslie Meyn, PhD
• Organization: University Of Pittsburgh

meynla@mwri.magee.edu

412-641-4233

Study Officials

• Katherine Bunge, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Sharon L Hillier, PhD

  University of Pittsburgh

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants will insert a placebo extended release vaginal film at Day 0. They are randomized to the timing of their first follow up visit (Day 3, 7, 10 or 14) to assess how long the film can be detected visually and/or one of its components remains detectable by biochemical assay in the lower genital tract.

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: May 25, 2018
• Study Start: May 22, 2018
• Primary Completion: December 4, 2018
• Study Completion: December 4, 2018
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)