Vaginal Film Administration and Placement Study: FLAG

NCT02908503 | Completed

• 1 other identifier: PRO16010551
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate use of four different vaginal films - two sizes and two textures. The vaginal films have no active ingredients or medications. Information will be gathered about each film (i.e. ease of insertion, proper placement, opinions about each). The results of this study will help investigators determine which type of vaginal film to use (and how to write product instructions) for future studies.

Conditions

Healthy Women

Outcome Measures

Primary Outcomes (2)

• correct insertion of vaginal films

  assessed by examination

  approximately 2 months

• ease of insertion of vaginal film

  assessed by questionnaire

  approximately 2 months

Secondary Outcomes (4)

• experience prior to film insertion

  approximately 2 months

• glycome/innate anti-HIV activity evaluation

  approximately 2 months

• experience during film insertion

  approximately 2 months

• experience after film insertion

  approximately 2 months

Study Arms (4)

1 x 2 inch PVA based film

OTHER

1 x 2 inch polyvinyl acetate (PVA) based vaginal film

Other: Placebo Film

2 x 2 inch PVA based film

OTHER

2 x 2 inch polyvinyl acetate (PVA) based vaginal film

Other: Placebo Film

1 x 2 cellulose based film

OTHER

1 x 2 cellulose based vaginal film

Other: Placebo Film

2 x 2 cellulose based film

OTHER

2 x 2 cellulose based vaginal film

Other: Placebo Film

Interventions

Placebo Film OTHER

placebo vaginal films

1 x 2 cellulose based film; 1 x 2 inch PVA based film; 2 x 2 cellulose based film; 2 x 2 inch PVA based film

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female, Age 18-40
• Able and willing to provide written informed consent to be screened for and enrolled in the study.
• Able and willing to provide adequate locator information at screening.
• HIV-uninfected based on documented testing performed in the previous 6 months or by study staff at screening.
• In general good health as determined by the site clinician
• Agree to abstain from any intravaginal or rectal product or device or penetration (including vaginal, anal, or oral sex, masturbation, or sex toys) between each film insertion and the collection of the CVL approximately 24 hours later. Agree to be sexually abstinent for 48 hours prior to the study visits (from enrollment to visit 10). Sexual activity in the 48 hours prior to screening is acceptable.
• Willingness to undergo all study-related assessments and procedures, including multiple speculum examinations, and follow all other 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 and to abstain from vaginal product usage with the exception of tampons over the study period.

You may not qualify if:

• Previous participation in a vaginal film study where participant was randomized to use film (i.e. FAME 02; FAME 04). Note: If participant was randomized to the gel arm, then she would be potentially eligible for participation in FLAG.
• Menopausal at screening (as defined as amenorrhea for one year or more without an alternative etiology)
• Hysterectomy
• Participant report of any of the following at screening:
• 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 screening (includes dilation and curettage or evacuation, and cryosurgery; does not include cervical biopsy for evaluation of an abnormal pap smear or IUD placement)
• Participation in a drug, spermicide and/or microbicide study in the 30 days prior to screening or anticipated participation in an investigational drug study in the next 8 weeks
• Currently pregnant or pregnancy within 90 days prior to screening
• Lactating
• Use of a diaphragm, NuvaRing®, or spermicide for contraception 5.) Urogenital infection or suspected infection within 14 days of enrollment including: symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis; or cervical infection, including Neisseria gonorrhoeae (GC), Chlamydia trachomatis (CT), or mucopurulent cervicitis; syphilis; HSV lesions, or other sores (Note: participants seropositive for HSV without active lesions will not be excluded); acute pelvic inflammatory disease; urinary tract infection
• \. Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment
• \. Menses or other vaginal bleeding at the time of enrollment\* or expecting menses in the 5 days after enrollment.
• \*Note, for women with monthly cycles, every attempt will be made to enroll these participants in the first half of their menstrual cycle. Women who have vaginal bleeding at the scheduled Enrollment Visit may return at a different date to be re-examined and possibly enrolled provided they are still within the screening window (maximum of 30 days between screening and enrollment) and meet all criteria.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• Sharon L Hillier, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: September 21, 2016
• Study Start: July 1, 2016
• Primary Completion: February 14, 2017
• Study Completion: February 14, 2017
• Last Updated: July 5, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)