Trial Outcomes & Findings for Efficacy of VR101 as a Personal Lubricant (NCT NCT04288752)

Last Updated: 2021-08-10

Results Overview

The Female Sexual Function Index (FSFI) is a survey validated to assess sexual function in women. The FSFI contains 19 questions, divided in to 6 characteristic domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. Although all of these characteristics may be improved by use of a personal lubricant, only the Lubrication Domain (FSFI-LD) is directly relevant to a lubricant's intended use. Primary Endpoint: Proportion of participants that experience increased vaginal lubrication that enhances ease and comfort of intimate sexual activity, defined as an FSFI-LD ≥ 4.5 (out of 6.0) with 4 consecutive weeks of weekly ring use.

Recruitment status

COMPLETED

Study phase

Target enrollment

176 participants

Primary outcome timeframe

4 weeks

Results posted on

2021-08-10

Participant Flow

None. Each enrolled subject was randomly assigned in a 1:1 ratio to receive either VR101 devices or sham rings. One enrolled subject was randomized but did not begin the treatment phase because she was unable to place the first device.

Participant milestones

Participant milestones
Measure	VR101 Lubricating Intravaginal Ring VR101 is a clear, flexible, torus-shaped lubricating intravaginal ring (IVR) manufactured from hollow tubing formed from Excipient Grade Thermoplastic Urethane Pathway® Polymer PY-PT42DE35 by hot-melt extrusion. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up. VR101 Lubricating Intravaginal Ring is a personal lubrication device, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.	Sham Ring Performance of VR101 will be compared to that of an inactive ring. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up. Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added.
Overall Study STARTED	87	88
Overall Study COMPLETED	81	85
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of VR101 as a Personal Lubricant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VR101 Lubricating Intravaginal Ring n=87 Participants VR101 is a clear, flexible, torus-shaped lubricating intravaginal ring (IVR) manufactured from hollow tubing formed from Excipient Grade Thermoplastic Urethane Pathway® Polymer PY-PT42DE35 by hot-melt extrusion. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up. VR101 Lubricating Intravaginal Ring: VR101 Lubricating Intravaginal Ring is a personal lubrication device, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.	Sham Ring n=88 Participants Performance of VR101 will be compared to that of an inactive ring. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up. Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added. Sham Ring: Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added.	Total n=175 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 12.4 • n=5 Participants	47.1 years STANDARD_DEVIATION 13.0 • n=7 Participants	49.3 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants	88 Participants n=7 Participants	175 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	81 Participants n=5 Participants	83 Participants n=7 Participants	164 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	86 Participants n=5 Participants	84 Participants n=7 Participants	170 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	VR101 Lubricating Intravaginal Ring n=87 Participants VR101 is a clear, flexible, torus-shaped lubricating intravaginal ring (IVR) manufactured from hollow tubing formed from Excipient Grade Thermoplastic Urethane Pathway® Polymer PY-PT42DE35 by hot-melt extrusion. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up. VR101 Lubricating Intravaginal Ring is a personal lubrication device, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.	Sham Ring n=88 Participants Performance of VR101 will be compared to that of an inactive ring. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up. Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added.
Proportion of Participants With Increased Female Sexual Function Index Lubrication Domain (FSFI-LD) Scores	57 Participants	43 Participants

Adverse Events

VR101 Lubricating Intravaginal Ring

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Sham Ring

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

R. Tyler McCabe, Ph.D.

J3 Bioscience, Inc

Phone: 801-550-9956

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	VR101 Lubricating Intravaginal Ring n=87 participants at risk VR101 is a clear, flexible, torus-shaped lubricating intravaginal ring (IVR) manufactured from hollow tubing formed from Excipient Grade Thermoplastic Urethane Pathway® Polymer PY-PT42DE35 by hot-melt extrusion. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up. VR101 Lubricating Intravaginal Ring: VR101 Lubricating Intravaginal Ring is a personal lubrication device, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.	Sham Ring n=88 participants at risk Performance of VR101 will be compared to that of an inactive ring. Subjects randomized to this arm will be asked to use each ring for 7 days and replace with a new ring each week for 4 weeks. This will be followed by an optional 2-week open-label extension with active rings and a 1-week follow-up. Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added. Sham Ring: Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added.
Reproductive system and breast disorders Excess Vaginal Secretions / Lubrication / Discharge - Moderate	4.6% 4/87 • Number of events 4 • Through study completion, approximately 5-7 weeks per participant.	0.00% 0/88 • Through study completion, approximately 5-7 weeks per participant.
Reproductive system and breast disorders Excess Vaginal Secretions / Lubrication / Discharge - Mild	11.5% 10/87 • Number of events 11 • Through study completion, approximately 5-7 weeks per participant.	2.3% 2/88 • Number of events 2 • Through study completion, approximately 5-7 weeks per participant.
Reproductive system and breast disorders Pelvic / Reproductive Tract Cramping - Moderate	2.3% 2/87 • Number of events 3 • Through study completion, approximately 5-7 weeks per participant.	1.1% 1/88 • Number of events 1 • Through study completion, approximately 5-7 weeks per participant.
Reproductive system and breast disorders Pelvic / Reproductive Tract Cramping	9.2% 8/87 • Number of events 8 • Through study completion, approximately 5-7 weeks per participant.	2.3% 2/88 • Number of events 2 • Through study completion, approximately 5-7 weeks per participant.
Reproductive system and breast disorders Vaginal Pain / Discomfort - Moderate	1.1% 1/87 • Number of events 1 • Through study completion, approximately 5-7 weeks per participant.	0.00% 0/88 • Through study completion, approximately 5-7 weeks per participant.
Reproductive system and breast disorders Vaginal Pain / Discomfort - Mild	2.3% 2/87 • Number of events 2 • Through study completion, approximately 5-7 weeks per participant.	2.3% 2/88 • Number of events 2 • Through study completion, approximately 5-7 weeks per participant.
Reproductive system and breast disorders Non-Menstrual Bleeding (Reproductive Tract) - Moderate	0.00% 0/87 • Through study completion, approximately 5-7 weeks per participant.	1.1% 1/88 • Number of events 1 • Through study completion, approximately 5-7 weeks per participant.
Reproductive system and breast disorders Non-Menstrual Bleeding (Reproductive Tract) - Mild	3.4% 3/87 • Number of events 3 • Through study completion, approximately 5-7 weeks per participant.	1.1% 1/88 • Number of events 1 • Through study completion, approximately 5-7 weeks per participant.
Renal and urinary disorders Increased Urinary Urge / Urinary Incontience - Moderate	1.1% 1/87 • Number of events 1 • Through study completion, approximately 5-7 weeks per participant.	0.00% 0/88 • Through study completion, approximately 5-7 weeks per participant.
Renal and urinary disorders Increased Urinary Urge / Urinary Incontience - Mild	1.1% 1/87 • Number of events 2 • Through study completion, approximately 5-7 weeks per participant.	0.00% 0/88 • Through study completion, approximately 5-7 weeks per participant.
Renal and urinary disorders Urinary Tract / Bladder Infection - Moderate	2.3% 2/87 • Number of events 2 • Through study completion, approximately 5-7 weeks per participant.	1.1% 1/88 • Number of events 1 • Through study completion, approximately 5-7 weeks per participant.
Reproductive system and breast disorders Vaginal Irritation / Vaginitis - Moderate	2.3% 2/87 • Number of events 2 • Through study completion, approximately 5-7 weeks per participant.	0.00% 0/88 • Through study completion, approximately 5-7 weeks per participant.
Reproductive system and breast disorders Vaginal Yeast Infection - Mild	0.00% 0/87 • Through study completion, approximately 5-7 weeks per participant.	2.3% 2/88 • Number of events 2 • Through study completion, approximately 5-7 weeks per participant.
Reproductive system and breast disorders Device Interference with Intercourse - Mild	1.1% 1/87 • Number of events 1 • Through study completion, approximately 5-7 weeks per participant.	0.00% 0/88 • Through study completion, approximately 5-7 weeks per participant.
Reproductive system and breast disorders Penile Discomfort (Partner) - Mild	1.1% 1/87 • Number of events 1 • Through study completion, approximately 5-7 weeks per participant.	0.00% 0/88 • Through study completion, approximately 5-7 weeks per participant.
General disorders Hot Flashes - Mild	1.1% 1/87 • Number of events 1 • Through study completion, approximately 5-7 weeks per participant.	0.00% 0/88 • Through study completion, approximately 5-7 weeks per participant.
Renal and urinary disorders Burning During Urination - Mild	1.1% 1/87 • Through study completion, approximately 5-7 weeks per participant.	0.00% 0/88 • Through study completion, approximately 5-7 weeks per participant.
General disorders Intermittent Headaches - Mild	1.1% 1/87 • Number of events 1 • Through study completion, approximately 5-7 weeks per participant.	0.00% 0/88 • Through study completion, approximately 5-7 weeks per participant.
General disorders Abdominal Cramping - Mild	0.00% 0/87 • Through study completion, approximately 5-7 weeks per participant.	1.1% 1/88 • Number of events 1 • Through study completion, approximately 5-7 weeks per participant.
General disorders Nausea - Mild	0.00% 0/87 • Through study completion, approximately 5-7 weeks per participant.	1.1% 1/88 • Number of events 1 • Through study completion, approximately 5-7 weeks per participant.
Renal and urinary disorders Bladder Spasms - Mild	0.00% 0/87 • Through study completion, approximately 5-7 weeks per participant.	1.1% 1/88 • Number of events 1 • Through study completion, approximately 5-7 weeks per participant.
General disorders Other - Not Related to Device	13.8% 12/87 • Number of events 13 • Through study completion, approximately 5-7 weeks per participant.	22.7% 20/88 • Number of events 23 • Through study completion, approximately 5-7 weeks per participant.