N/A
N=8
Women's Input on Sexual Health
Intravaginal Ring Use
Bottom Line
View on ClinicalTrials.gov: NCT02057419 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: USPE Scale Scores — 3.73; 3.63; 1.85; 2.02 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The Miriam Hospital
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY USPE Scale Scores |
3.73; 3.63; 1.85; 2.02; 3.13; 3.07 | — |
Summary
The purpose of this study is to answer the following question: How do user sensory perceptions and experiences (USPEs) for IVRS differ between initial and continued use and how can this knowledge help product developers better understand how to design new IVR products and develop behavioral (or point-of-care) interventions to optimize use?
Eligibility Criteria
Inclusion Criteria
- are between the ages of 18 and 45 at prescreening,
- report vaginal sex with a man in the past month at prescreening,
- are not pregnant (self-report, confirmed at V1, V2, and V3 by urine HcG test) and report no intention to become pregnant during the course of the study,
- report negative or unknown HIV status,
- report a need for contraceptive products and
- are willing and able to provide informed consent.
Exclusion Criteria
- self-report pregnancy, have a positive urine pregnancy test at Visits 1, 2, or 3, or intend to become pregnant during the course of the study,
- self-report breast feeding,
- self-report a vaginal delivery or other reproductive surgical procedure in the past 30 days,
- self-report being HIV-positive,
- self-report being diagnosed with or having an active sexually transmitted infection (STI) in the past 12 months,
- self-report an allergy or sensitivity to any of the study products,
- do not have a cell phone or internet access,
- are unable or unwilling to give informed consent, or
- have any condition that, in the opinion of the study clinician(s) or principle investigator, would compromise the participant's ability to participate in the study
Data sourced from ClinicalTrials.gov (NCT02057419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.