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Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections

StatusRecruiting
PhasePhase 4
SponsorWestat
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 15, 2028 → Jun 30, 2029
See other at-risk trials from Westat

Record History

  1. Primary and study completion pushed from Jun 15, 2028 to Jun 30, 2029 Primary endpoints: details revised at 1 of 1 entry · Interventions: Doxycycline hyclate delayed released 200 mg (Drug), Doxycycline hyclate delayed released 200 mg weekly (Drug), Per standard of care with… to Doxycycline hyclate delayed released 200 mg (Drug), Doxycycline hyclate delayed released 200 mg weekly (Drug), Per standard of care with… · Eligibility criteria expanded, about 16 words · 2 more Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Interventions: Doxycycline hyclate delayed released 200 mg (Drug), Doxycycline hyclate delayed released 200 mg weekly (Drug), Per standard of care with… to Doxycycline hyclate delayed released 200 mg (Drug), Doxycycline hyclate delayed released 200 mg weekly (Drug), Per standard of care with…
    • Eligibility criteria expanded, about 16 words
    • Study description revised
    • Site details revised at 2 of 13 sites
  2. Recruitment opened Study sites: 12 to 13 · Start date changed from estimate of Jan 5, 2026 to Feb 27, 2026v9 Show 2 more changesShow less
    • Study sites: 12 to 13
    • Start date changed from estimate of Jan 5, 2026 to Feb 27, 2026
  3. Start date: Nov 28, 2025 to Jan 5, 2026 Primary and study completion dates: May 31, 2028 to Jun 15, 2028 · Interventions: Doxycycline hyclate delayed released 200 mg (Drug), Doxycycline hyclate delayed released 200 mg weekly (Drug) to Doxycycline hyclate delayed released 200 mg (Drug), Doxycycline hyclate delayed released 200 mg weekly (Drug), Per standard of care with…v8 Show 2 more changesShow less
    • Primary and study completion dates: May 31, 2028 to Jun 15, 2028
    • Interventions: Doxycycline hyclate delayed released 200 mg (Drug), Doxycycline hyclate delayed released 200 mg weekly (Drug) to Doxycycline hyclate delayed released 200 mg (Drug), Doxycycline hyclate delayed released 200 mg weekly (Drug), Per standard of care with…
  4. Trial status: Suspended to Not Yet Recruiting Primary completion date: Jun 30, 2027 to May 31, 2028 · Start date: May 15, 2025 to Nov 28, 2025 · Study sites: 11 to 12 · 4 morev7 Show 7 more changesShow less
    • Primary completion date: Jun 30, 2027 to May 31, 2028
    • Start date: May 15, 2025 to Nov 28, 2025
    • Study sites: 11 to 12
    • Completion date: Jun 30, 2028 to May 31, 2028
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Collaborators revised (6)

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: Funding suspended Site contacts updated at 11 of 11 sitesv6 Show 1 more changeShow less
    • Site contacts updated at 11 of 11 sites
Show 4 earlier versionsHide 4 earlier versions
  1. Phase: Phase 3 to Phase 4 Start date: Feb 15, 2025 to May 15, 2025 · Study sites: 12 to 11 · Eligibility criteria expanded, about 1 word · 1 morev5 Show 4 more changesShow less
    • Start date: Feb 15, 2025 to May 15, 2025
    • Study sites: 12 to 11
    • Eligibility criteria expanded, about 1 word
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Collaborators: 5 to 6v4 See this version in full on ClinicalTrials.gov ↗
  3. Eligibility criteria shortened, about 7 words Study description shortened, about 2 wordsv3 Show 1 more changeShow less
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Westat
6 trials monitored
See 1 trial at risk
The goal of this open-label, randomized trial is to assess the efficacy of doxycycline prophylaxis in reducing incidences of bacterial sexually transmitted infections (STIs) among adolescent and young adult females while also evaluating acceptability and antimicrobial resistance in order to inform public health policy.
Trial Details
NCT Number NCT06738407
Lead Sponsor Westat
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), Florida State University, The Office of the Director, National Institutes of Health (NIH)
Conditions Gonorrhea, Chlamydia, Syphilis, Sexually Transmitted Infections (STIs)
Enrollment 760 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov