Last reviewed · How we verify
NCT06046053
MATRIX-002: Trial to Assess Acceptability and Safety of Two Placebo Vaginal Films
EARLY_PHASE1 trial testing Placebo Vaginal Film with Square Corners in Safety in 100 participants. Completed in 10 December 2024.
10 December 2024
Quick facts
| Lead sponsor | Rohan, Lisa, PhD |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 100 |
| Start date | 18 October 2023 |
| Primary completion | 10 December 2024 |
| Estimated completion | 10 December 2024 |
| Sites | 5 locations across Zimbabwe, South Africa, Kenya, United States |
Drugs / interventions tested
- Placebo Vaginal Film with Square Corners — full drug profile →
- Placebo Vaginal Film with Rounded Corners — full drug profile →
Conditions studied
- Safety — all drugs for Safety →
- Acceptability — all drugs for Acceptability →
- Usability — all drugs for Usability →
Sponsor
Rohan, Lisa, PhD — full company profile →
Who can join
Adults 18 to 45, female only, with Safety or Acceptability. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, Kenya, South Africa, and Zimbabwe. The study will assess the acceptability and safety of two placebo vaginal films. The placebo films do not contain any active medication, are the same size, but differ by shape (square versus rounded corners). Participants will be randomly assigned to one of the two films and asked to use (self-insert) the assigned film two times (approximately one month apart). Participants will be asked to refrain from sexual activity during the first month of use and may resume usual sexual activity during the second month of use. The study involves answering questions, undergoing pelvic examinations, and collecting blood and vaginal fluid samples. The study involves a total of 10 visits/contacts, including in person visits and telephone calls over approximately 9 weeks. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in depth interviews to further assess acceptability, attitudes, and experiences with film use to gauge interest in the future use of vaginal films as a HIV prevention option.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06046053
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Safety
Currently open trials in the same condition.
- NCT06818994 — Safety and Efficacy of Psilocybin-assisted Psychotherapy for Demoralization Syndrome in Patients Diagnosed With Advanced · Phase 1 · recruiting
- NCT07286656 — A Study of GensSci098 in Subjects With Graves' Disease · Phase 1 · recruiting
- NCT06760208 — A Study to Learn More About Prevenar 20 Once it is Out in the Korean Market · recruiting
- NCT07157215 — An International Survey on the Use of NIV Outside the ICU · recruiting
- NCT06976229 — Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06046053 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rohan, Lisa, PhD
- Last refreshed: 19 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06046053.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing