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

• Sponsor: Katherine Bunge (Other)
• Overall Status: Completed
• CT.gov ID: NCT03537092
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 64
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.4
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Safety of Vaginal Film Use	Device: Vaginal Film	N/A

Detailed Description

This research study will involve the use of a placebo vaginal film. Investigators want to evaluate the safety of the film and understand the acceptability and length of time for the film to dissolve once inserted into the vagina. In future studies, this film may have medication added to it to deliver medication over an extended period of time (i.e. extended release).

All of the eligible women will be randomized (distributed by chance, like rolling a dice) at the Enrollment Visit to one of four study groups. The groups will specify what day Visit 3 will be performed.

Participants will have an equal likelihood of being in any one of the four groups. Neither the participant nor the study staff can choose the group or can change the group the participant has been placed into. Regardless of which group the participant is in she will only use the film once during the study. Women in all of the study groups will have the same study visit schedule except for the timing of Visit 3.

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Study of the Safety and Acceptability of a Placebo Vaginal Film: FAME101
• Actual Study Start Date: May 22, 2018
• Actual Primary Completion Date: Dec 4, 2018
• Actual Study Completion Date: Dec 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vaginal Film 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; 2" x 2" vaginal film with no active drug

Outcome Measures

Primary Outcome Measures

1. Grade 2 or Higher Urogenital System Adverse Event Related to Film Use [30 days]

   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

Secondary Outcome Measures

1. Correct Insertion of Vaginal Film [30 days]

   Vaginal film was correctly inserted by the participant as assessed by clinical investigator

2. Difficulty of Vaginal Film Insertion [30 days]

   The perceived difficulty of vaginal film insertion by the participant will be assessed on a 4 point Likert scale

3. Acceptability of Vaginal Film Use [30 days]

   The acceptability of vaginal film use by the participant will be assessed on a 5 point Likert scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Women must meet all the following criteria to be eligible for inclusion in the study:

1. Age 18 through 45 years (inclusive) at screening

2. Able and willing to provide written informed consent to be screened for and to take part in the study.

3. Able and willing to provide adequate locator information

4. HIV-uninfected based on testing performed by study staff at screening (per algorithm in Appendix II)

5. In general good health as determined by the site clinician

6. Agree to be sexually abstinent for 48 hours prior to each visit and from Visit 2 to Visit 3

7. 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.

8. Willingness to undergo all study-related assessments and follow all study-related procedures

9. At screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, or vaginal products while enrolled in this trial

Exclusion Criteria:

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.

1. Menopause (as defined as amenorrhea for one year or more without an alternative etiology)

2. Hysterectomy

3. Participant report of any of the following:

4. Known adverse reaction to any of the study products (ever)

5. Known adverse reaction to latex (ever)

6. Non- therapeutic injection drug use in the 12 months prior to Screening

7. 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)

8. 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

9. Currently pregnant or pregnancy within 42 days prior to enrollment

10. Currently lactating

11. Use of a diaphragm, NuvaRing®, or spermicide for contraception

12. Internal vaginal use of any device or product (except tampons) in the 48 hours prior to enrollment

13. 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.

14. Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment

15. 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

16. Menses-like bleeding at the time of the Enrollment visit* or expected menses-like bleeding within 14 days of the Enrollment visit (*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 and meet all criteria.)

17. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Magee womens Hospital of UPMC	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Katherine Bunge, MD, University of Pittsburgh
• Study Chair: Sharon L Hillier, PhD, University of Pittsburgh

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Sep 20, 2017

More Information

Publications

None provided.

• Responsible Party: Katherine Bunge, Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03537092
• Other Study ID Numbers: PRO17090024; ES-38322; U19AI120249
• First Posted: May 25, 2018
• Last Update Posted: Jan 13, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Recruitment Details	From 05/22/2018 to 11/01/2018, 84 women were recruited and screened from gynecology clinics at Magee-Womens Hospital at the University of Pittsburgh Medical Center and the surrounding community. The study was fully enrolled with 64 participants on 11/13/2018.

Arm/Group Title	Vaginal Film
Arm/Group Description	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) Vaginal Film: 2" x 2" vaginal film with no active drug
Period Title: Overall Study
STARTED	64
COMPLETED	64
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Vaginal Film
Arm/Group Description	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) Vaginal Film: 2" x 2" vaginal film with no active drug
Overall Participants	64
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	26.5
Sex: Female, Male (Count of Participants)
Female	64 100%
Male	0 0%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic, White	36 56.3%
Non-Hispanic, Black	17 26.6%
Hispanic, Black	1 1.6%
Asian	6 9.4%
Multi-ethnic	4 6.3%
Region of Enrollment (participants) [Number]
United States	64 100%
Marital Status (Count of Participants)
Never married	52 81.3%
Married/domestic partner	10 15.6%
Divorced	1 1.6%
Separated	1 1.6%
Education (Count of Participants)
High school or less	6 9.4%
Some college	23 35.9%
College graduate	27 42.2%
Trade/technical school	8 12.5%
Current smoker (Count of Participants)
Count of Participants [Participants]	13 20.3%
Ever been pregnant (Count of Participants)
Count of Participants [Participants]	28 43.8%
Current sexual partner (Count of Participants)
Count of Participants [Participants]	43 67.2%

Outcome Measures

1. Primary Outcome

Title	Grade 2 or Higher Urogenital System Adverse Event Related to Film Use
Description	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
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vaginal Film
Arm/Group Description	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) Vaginal Film: 2" x 2" vaginal film with no active drug
Measure Participants	64
Count of Participants [Participants]	2 3.1%

2. Secondary Outcome

Title	Correct Insertion of Vaginal Film
Description	Vaginal film was correctly inserted by the participant as assessed by clinical investigator
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vaginal Film
Arm/Group Description	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) Vaginal Film: 2" x 2" vaginal film with no active drug
Measure Participants	64
Count of Participants [Participants]	47 73.4%

3. Secondary Outcome

Title	Difficulty of Vaginal Film Insertion
Description	The perceived difficulty of vaginal film insertion by the participant will be assessed on a 4 point Likert scale
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants who responded to this survey question after product insertion.

Arm/Group Title	Vaginal Film
Arm/Group Description	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) Vaginal Film: 2" x 2" vaginal film with no active drug
Measure Participants	63
Very difficult	8 12.5%
Moderately difficult	11 17.2%
Slightly difficult	28 43.8%
Easy	16 25%

4. Secondary Outcome

Title	Acceptability of Vaginal Film Use
Description	The acceptability of vaginal film use by the participant will be assessed on a 5 point Likert scale
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Participants who responded to the question 'Overall I was satisfied with my experience with this film, once it was inserted' at Visit 4.

Arm/Group Title	Vaginal Film
Arm/Group Description	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) Vaginal Film: 2" x 2" vaginal film with no active drug
Measure Participants	64
Do not agree at all	4 6.3%
Agree a little	6 9.4%
Agree somewhat	8 12.5%
Agree a lot	20 31.3%
Agree completely	26 40.6%

Adverse Events

Time Frame	1 month
Arm/Group Title	Vaginal Film
Arm/Group Description	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) Vaginal Film: 2" x 2" vaginal film with no active drug
All Cause Mortality
	Vaginal Film
	Affected / at Risk (%)	# Events
Total	0/64 (0%)
Serious Adverse Events
	Vaginal Film
	Affected / at Risk (%)	# Events
Total	0/64 (0%)
Other (Not Including Serious) Adverse Events
	Vaginal Film
	Affected / at Risk (%)	# Events
Total	31/64 (48.4%)
Infections and infestations
Vaginal infection	3/64 (4.7%)	3
Reproductive system and breast disorders
Bleeding abnormality	5/64 (7.8%)	5
Genital itching	4/64 (6.3%)	4
Pelvic pain	7/64 (10.9%)	7
Vaginal discharge	13/64 (20.3%)	13

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.