Trial Outcomes & Findings for A Study of the Safety and Acceptability of a Placebo Vaginal Film: FAME101 (NCT NCT03537092)

NCT ID: NCT03537092

Last Updated: 2020-01-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2020-01-13

Participant Flow

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.

Participant milestones

Measure	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) Vaginal Film: 2" x 2" vaginal film with no active drug
Overall Study STARTED	64
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Vaginal Film n=64 Participants 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
Age, Continuous	26.5 years n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic, White	36 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic, Black	17 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic, Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants
Race/Ethnicity, Customized Multi-ethnic	4 Participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants
Marital Status Never married	52 Participants n=5 Participants
Marital Status Married/domestic partner	10 Participants n=5 Participants
Marital Status Divorced	1 Participants n=5 Participants
Marital Status Separated	1 Participants n=5 Participants
Education High school or less	6 Participants n=5 Participants
Education Some college	23 Participants n=5 Participants
Education College graduate	27 Participants n=5 Participants
Education Trade/technical school	8 Participants n=5 Participants
Current smoker	13 Participants n=5 Participants
Ever been pregnant	28 Participants n=5 Participants
Current sexual partner	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Vaginal Film n=64 Participants 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
Grade 2 or Higher Urogenital System Adverse Event Related to Film Use	2 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	Vaginal Film n=64 Participants 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
Correct Insertion of Vaginal Film	47 Participants

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Measure	Vaginal Film n=63 Participants 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
Difficulty of Vaginal Film Insertion Very difficult	8 Participants
Difficulty of Vaginal Film Insertion Moderately difficult	11 Participants
Difficulty of Vaginal Film Insertion Slightly difficult	28 Participants
Difficulty of Vaginal Film Insertion Easy	16 Participants

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Measure	Vaginal Film n=64 Participants 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
Acceptability of Vaginal Film Use Do not agree at all	4 Participants
Acceptability of Vaginal Film Use Agree a little	6 Participants
Acceptability of Vaginal Film Use Agree somewhat	8 Participants
Acceptability of Vaginal Film Use Agree a lot	20 Participants
Acceptability of Vaginal Film Use Agree completely	26 Participants

Adverse Events

Vaginal Film

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vaginal Film n=64 participants at risk 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
Reproductive system and breast disorders Bleeding abnormality	7.8% 5/64 • Number of events 5 • 1 month
Reproductive system and breast disorders Genital itching	6.2% 4/64 • Number of events 4 • 1 month
Reproductive system and breast disorders Pelvic pain	10.9% 7/64 • Number of events 7 • 1 month
Reproductive system and breast disorders Vaginal discharge	20.3% 13/64 • Number of events 13 • 1 month
Infections and infestations Vaginal infection	4.7% 3/64 • Number of events 3 • 1 month

Additional Information

Leslie Meyn, PhD

University Of Pittsburgh

Phone: 412-641-4233

Email: meynla@mwri.magee.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place