- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03537092
A Study of the Safety and Acceptability of a Placebo Vaginal Film: FAME101 (FAME101)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Magee Womens Hospital of UPMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Women must meet all the following criteria to be eligible for inclusion in the study:
- 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
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.
- 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
- 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.)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
|
2" x 2" vaginal film with no active drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grade 2 or Higher Urogenital System Adverse Event Related to Film Use
Time Frame: 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
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correct Insertion of Vaginal Film
Time Frame: 30 days
|
Vaginal film was correctly inserted by the participant as assessed by clinical investigator
|
30 days
|
Difficulty of Vaginal Film Insertion
Time Frame: 30 days
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The perceived difficulty of vaginal film insertion by the participant will be assessed on a 4 point Likert scale
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30 days
|
Acceptability of Vaginal Film Use
Time Frame: 30 days
|
The acceptability of vaginal film use by the participant will be assessed on a 5 point Likert scale
|
30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Sharon L Hillier, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PRO17090024
- ES-38322 (Other Identifier: DAIDS Protocol)
- U19AI120249 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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