Trial Outcomes & Findings for Women's Input on Sexual Health (NCT NCT02057419)

NCT ID: NCT02057419

Last Updated: 2025-10-24

Results Overview

User sensory perceptions and experiences (USPEs) with the IVR will be captured approximately monthly over a 90 day use period. USPE Sum of averaged item means/# items (min:max 1:5); 1=Do not agree at all;2=Agree a little;3=Agree somewhat;4=Agree a lot;5=Agree completely. Product: IVR USPE Scales: Initial Penetration and First Strokes: Smoothness/lubricity; Awareness: Feel (not) intravaginally during sex; Discharge Look: Appearance of discharge; Discharge: Sensations of discharge during and after sex inside and outside body; Pleasure: Participant and partner's stimulation A higher score indicates greater agreement with subscale characteristics being reported on.

Recruitment status

COMPLETED

Target enrollment

8 participants

Primary outcome timeframe

Up to 3 months

Results posted on

2025-10-24

Participant Flow

Recruited (RI, MA USA) via call-lists, flyers, ads, internet/social media, clinics, CBOs, word-of-mouth.

Participant milestones

Participant milestones
Measure	Intravaginal Ring Users Use IVR for 3-month period and report user sensory perceptions and experiences.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Women's Input on Sexual Health

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravaginal Ring Users n=8 Participants Use IVR for 3-month period and report user sensory perceptions and experiences.
Age, Customized 18-29	6 Participants n=5 Participants
Age, Customized 30-45	2 Participants n=5 Participants
Sex/Gender, Customized Female	8 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants
Race/Ethnicity, Customized Latina or Hispanic	2 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants
Marital Status Never Married	7 Participants n=5 Participants
Marital Status Married	0 Participants n=5 Participants
Marital Status Separated	0 Participants n=5 Participants
Marital Status Divorced	1 Participants n=5 Participants
Marital Status Widowed	0 Participants n=5 Participants
Yearly Income Less than $15,000 a year	0 Participants n=5 Participants
Yearly Income $15,000 to $36,000 a year	6 Participants n=5 Participants
Yearly Income $36,000 or more a year	2 Participants n=5 Participants
Health Insurance Coverage Through a current or former employer or union	4 Participants n=5 Participants
Health Insurance Coverage Purchased directly from an insurance company	1 Participants n=5 Participants
Health Insurance Coverage Medicare due to a disability	0 Participants n=5 Participants
Health Insurance Coverage Medicaid, medical assistance, or other kind of government assistance plan	0 Participants n=5 Participants
Health Insurance Coverage TRICARE or other military health care	0 Participants n=5 Participants
Health Insurance Coverage Covered by VA healthcare	0 Participants n=5 Participants
Health Insurance Coverage Covered by the Indian Health Service	0 Participants n=5 Participants
Health Insurance Coverage Another kind of health care insurance or health coverage plan_Parents' Insurance	1 Participants n=5 Participants
Health Insurance Coverage Currently do not have health insurance	2 Participants n=5 Participants
Typical Tampon Use Yes	5 Participants n=5 Participants
Typical Tampon Use No	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 months

Outcome measures

Outcome measures
Measure	Intravaginal Ring Users n=8 Participants Use IVR for 3-month period and report user sensory perceptions and experiences.
USPE Scale Scores Initial Penetration & First Strokes (Month 1 IVR)	3.73 score on a scale Standard Deviation 1.55
USPE Scale Scores Initial Penetration & First Strokes (Month 3 IVR)	3.63 score on a scale Standard Deviation 1.21
USPE Scale Scores Discharge (Month 1 IVR)	1.85 score on a scale Standard Deviation 1.41
USPE Scale Scores Discharge (Month 3 IVR)	2.02 score on a scale Standard Deviation 1.49
USPE Scale Scores Discharge Look (Month 1 IVR)	3.13 score on a scale Standard Deviation 1.58
USPE Scale Scores Discharge Look (Month 3 IVR)	3.07 score on a scale Standard Deviation 1.59
USPE Scale Scores Awareness (Month 1 IVR)	1.84 score on a scale Standard Deviation 0.86
USPE Scale Scores Awareness (Month 3 IVR)	1.82 score on a scale Standard Deviation 1.02
USPE Scale Scores Pleasure (Month 1 IVR)	1.63 score on a scale Standard Deviation 0.63
USPE Scale Scores Pleasure (Month 3 IVR)	2.81 score on a scale Standard Deviation 1.12

Adverse Events

Intravaginal Ring Users

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intravaginal Ring Users n=8 participants at risk Use IVR for 3-month period and report user sensory perceptions and experiences.
Reproductive system and breast disorders Increased Vaginal Discharge	12.5% 1/8 • Number of events 1 • 3 months
Infections and infestations Tooth Infection	12.5% 1/8 • Number of events 1 • 3 months

Additional Information

Dr Kate Guthrie, Principal Investigator, Project WISH Lead Investigator

The Miriam Hospital

Phone: 401-793-8180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place