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NCT06007534: DOXY-PK
Pharmacokinetic Characterization of a Single 200 mg Dose of Doxycycline in Post-exposure Prophylaxis (PEP) of Sexually Transmitted Infections in Different Biological Compartments
NA trial testing Samples in Post-exposure Prophylaxis in 25 participants. Currently enrolling.
25 April 2025
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 25 |
| Start date | 25 October 2023 |
| Primary completion | 25 April 2025 |
| Estimated completion | 25 April 2025 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Samples — full drug profile →
Conditions studied
- Post-exposure Prophylaxis — all drugs for Post-exposure Prophylaxis →
- Sexually Transmitted Diseases — all drugs for Sexually Transmitted Diseases →
- Doxycycline — all drugs for Doxycycline →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 18 to 100, male only, with Post-exposure Prophylaxis or Sexually Transmitted Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Post-exposure prophylaxis (PEP) using doxycycline 200 mg within 24 hours of unprotected sexual intercourse to prevent sexually transmitted infections has demonstrated a reduction in the incidence of chlamydial and syphilis infections and syphilis infection by 70% and 73% in men who have sex with men (MSM) undergoing pre-exposure prophylaxis prophylaxis (PrEP) for HIV. Other studies are underway or in development on doxycycline prophylaxis for bacterial STIs, which are particularly common in this population. Monitoring adherence to PEP is of great interest in guaranteeing the effectiveness of this strategy and to be able to assess the uptake of PEP among PrEP users. Among the many methods for assessing adherence, measuring drug concentrations is a more accurate measure of adherence than self-reporting. The therapeutic monitoring of doxycycline and the assessment of adherence have been described using plasma and hair samples, allowing estimation of intake over the last 3-4 days and 4 months, respectively. Nevertheless, these biological matrices present several limitations for application in clinical practice: reflecting the duration of exposure should be more in line with the frequency of visits (2 months), and the collection of hair samples may be difficult due to refusal or short hair. On the other hand, interpretation of the hair assay is limited by the degradation of doxycycline in this matrix, which could lead to underestimation of drug intake. By Therefore, new biological matrices are needed for more accurate assessment of doxycycline adherence in post-exposure prevention monitoring. The objective is to evaluate the pharmacokinetics of doxycycline in plasma, whole blood, dried blood spots (DBS), urine and hair after a single dose of doxycycline in men using oral doxycycline for post-exposure prophylaxis of sexually transmitted infections (syphilis or Chlamydia trachomatis) and having sex with men.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06007534
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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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 NCT06007534 (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 Assistance Publique - Hôpitaux de Paris
- Last refreshed: 19 September 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/NCT06007534.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing