CompletedNot Applicable

Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views

United Kingdom617 participantsStarted 2024-01-15

Plain-language summary

Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken).

Age range25 Years – 65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Individuals aged 25-65 years.
✓. People assigned female at birth (AFAB).
✓. Sexually active individuals. In this case, "sexually active" is defined as having penetrative vaginal sex.
✓. Group 1 only: Confirmed HPV+ diagnosis within the past 4 weeks.
✓. Willingness to give informed consent and adhere to trial procedures.

✕. Previous hysterectomy or total hysterectomy with removal of cervix
✕. Known allergy or sensitivity to tampons
✕. History of TSS (both tampon-associated and non-tampon associated)
✕. Individuals who are pregnant or breastfeeding.
✕. Participation in another interventional clinical trial or use of investigational drugs in the last 30 days.
✕. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. -

Evaluate the diagnostic accuracy of the Daye Diagnostic Tampon for detecting Chlamydia, Gonorrhea, BV and HPV

Timeframe: Within 4 weeks of the samples being received at the lab.

NCT IDNCT06154239

SponsorAnne's Day Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-18