Healthy WomenFLAGNCT02908503
Vaginal Film Administration and Placement Study: FLAG
A study of Healthy Women, run by University of Pittsburgh at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 14 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Women who meet any of the following criteria by participant report will be excluded from the study. Of note, the study is limited to premenopausal women with an intact uterus because the mucosal immune environment differs substantially between pre- and post- menopausal women. Therefore, inclusion of post-menopausal women would introduce heterogeneity into the population.
- 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)
Show all 17Show fewer
- 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
- 6. Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment
- 7. 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.
- 8. Any condition that, in the opinion of the Investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
All women will use all 4 products in a randomized study design with a crossover evaluation during 10 visits over two months. Visits will be scheduled when the participant is not menstruating/bleeding. The sequence of film use will be randomized. Study procedures will involve a screening visit (VISIT 1) during which a baseline cervicovaginal lavage will be collected and infections will be excluded. After randomization (VISIT 2) women will be given instructions and instructed to insert the first film. An external genital examination will be performed after the participant inserts the film to verify film placement. In the event a participant has difficulty placing the film, the study clinician may place the film for them. Following each film insertion, a questionnaire will be administered to obtain feedback regarding ease of administration. Thirty minutes after product insertion a clinician will visualize film placement in the vagina by speculum examination. Women will be counseled to avoid sexual activity or vaginal product usage before VISIT 3 scheduled for the following day. At visit 3 women will have a speculum examination to assess whether the film has completed disintegrated and a CVL sample will be collected. Women will be given an appointment for the next film insertion in 7-20 days. The general sequence of events will be repeated for each subsequent film. At the next visit (VISIT 4) women will insert the second film and have the same evaluation as visit 2. A CVL sample will be collected 24 hours later (VISIT 5). Women will be asked to return to insert another film 7-20 days later (VISIT 6) and a CVL sample will be collected the next day (VISIT 7). Women will receive the final film 7-20 days later (VISIT 8) and have the final CVL collection following film insertion the next day (VISIT 9). A final visit (VISIT 10) will be scheduled >14 days after visit 9. During this visit a CVL will be collected for glycomic and innate antiviral activity studies and an in depth interview will be conducted in order to gain insights into the role of film polymer and size on perceived ease of insertion across the four film types.
- Conditions
- Healthy Women
- Being tested
- Placebo Film
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo FilmOther
placebo vaginal films
| Study group | Role | What they receive |
|---|---|---|
| 1 x 2 inch PVA based film | Other | 1 x 2 inch polyvinyl acetate (PVA) based vaginal film Receives: Other: Placebo Film |
| 2 x 2 inch PVA based film | Other | 2 x 2 inch polyvinyl acetate (PVA) based vaginal film Receives: Other: Placebo Film |
| 1 x 2 cellulose based film | Other | 1 x 2 cellulose based vaginal film Receives: Other: Placebo Film |
| 2 x 2 cellulose based film | Other | 2 x 2 cellulose based vaginal film Receives: Other: Placebo Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
correct insertion of vaginal films
assessed by examination
Measured: approximately 2 months
ease of insertion of vaginal film
assessed by questionnaire
Measured: approximately 2 months
Secondary outcomes (4)
experience prior to film insertion
as assessed by participant interviews
Measured: approximately 2 months
glycome/innate anti-HIV activity evaluation
laboratory testing including cervicovaginal lavage
Measured: approximately 2 months
experience during film insertion
as assessed by participant interviews
Measured: approximately 2 months
experience after film insertion
as assessed by participant interviews
Measured: approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startJul 2016
- Primary completion14 Feb 2017
- Study completion14 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy WomenStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Sharon Hillier, University of Pittsburgh
- Investigators
- Sharon L Hillier, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908503
- Sponsor's protocol ID
- PRO16010551
- Acronym
- FLAG
- Status last verified
- Jul 2018
- First submitted
- 15 Aug 2016
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Film Administration and Placement Study: FLAG
- ClinicalTrials.gov ID
- NCT02908503
- Acronym / sponsor ID
- FLAG / PRO16010551
- Conditions
- Healthy Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Jul 2016
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All women will use all 4 products in a randomized study design with a crossover evaluation during 10 visits over two months. Visits will be scheduled when the participant is not menstruating/bleeding. The sequence of film use will be randomized. Study procedures will involve a screening visit (VISIT 1) during which a baseline cervicovaginal lavage will be collected and infections will be excluded. After randomization (VISIT 2) women will be given instructions and instructed to insert the first film. An external genital examination will be performed after the participant inserts the film to verify film placement. In the event a participant has difficulty placing the film, the study clinician may place the film for them. Following each film insertion, a questionnaire will be administered to obtain feedback regarding ease of administration. Thirty minutes after product insertion a clinician will visualize film placement in the vagina by speculum examination. Women will be counseled to avoid sexual activity or vaginal product usage before VISIT 3 scheduled for the following day. At visit 3 women will have a speculum examination to assess whether the film has completed disintegrated and a CVL sample will be collected. Women will be given an appointment for the next film insertion in 7-20 days. The general sequence of events will be repeated for each subsequent film. At the next visit (VISIT 4) women will insert the second film and have the same evaluation as visit 2. A CVL sample will be collected 24 hours later (VISIT 5). Women will be asked to return to insert another film 7-20 days later (VISIT 6) and a CVL sample will be collected the next day (VISIT 7). Women will receive the final film 7-20 days later (VISIT 8) and have the final CVL collection following film insertion the next day (VISIT 9). A final visit (VISIT 10) will be scheduled >14 days after visit 9. During this visit a CVL will be collected for glycomic and innate antiviral activity studies and an in depth interview will be conducted in order to gain insights into the role of film polymer and size on perceived ease of insertion across the four film types.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 x 2 inch PVA based film | Other | Other: Placebo Film1 x 2 inch polyvinyl acetate (PVA) based vaginal film |
| 2 x 2 inch PVA based film | Other | Other: Placebo Film2 x 2 inch polyvinyl acetate (PVA) based vaginal film |
| 1 x 2 cellulose based film | Other | Other: Placebo Film1 x 2 cellulose based vaginal film |
| 2 x 2 cellulose based film | Other | Other: Placebo Film2 x 2 cellulose based vaginal film |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- Women who meet any of the following criteria by participant report will be excluded from the study. Of note, the study is limited to premenopausal women with an intact uterus because the mucosal immune environment differs substantially between pre- and post- menopausal women. Therefore, inclusion of post-menopausal women would introduce heterogeneity into the population.
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Filmplacebo vaginal films | Other | 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 |
Primary outcome
correct insertion of vaginal films
Time frame: approximately 2 months
assessed by examination
ease of insertion of vaginal film
Time frame: approximately 2 months
assessed by questionnaire
4 secondary outcomes
experience prior to film insertion
Time frame: approximately 2 months
glycome/innate anti-HIV activity evaluation
Time frame: approximately 2 months
experience during film insertion
Time frame: approximately 2 months
experience after film insertion
Time frame: approximately 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon L Hillier, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy Women, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correct insertion of vaginal films (time frame: approximately 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.