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Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort

NCT04885556 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-13

No results posted yet for this study

Summary

Previous research has shown that semen deposition in the vagina after intercourse leads to dripping, discomfort, and vaginal odor. This study is evaluating a hygiene device designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal to determine if there is a reduction in dripping and odor, and to determine the amount of fluids absorbed.

Conditions

  • Vaginal Discharge
  • Dyspareunia
  • Female Sexual Dysfunction
  • Vaginitis
  • Bacterial Vaginoses

Interventions

DEVICE

Tampon-like device for absorption of sexual fluids

Subjects will insert a tampon-like device to absorb sexual fluids after intercourse

Sponsors & Collaborators

  • Atlantic Health System

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-05
Primary Completion
2021-09-15
Completion
2021-09-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04885556 on ClinicalTrials.gov