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NCT02094313
Effects of Decrease in Cholesterol Levels Induced by a Statin on Sperm Quality
Phase 1 trial testing Atorvastatin in Healthy Volunteers in 17 participants. Completed in 1 January 2014.
1 January 2014
Quick facts
| Lead sponsor | University Hospital, Clermont-Ferrand |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 17 |
| Start date | 1 January 2008 |
| Primary completion | 1 January 2014 |
| Estimated completion | 1 January 2014 |
| Sites | 1 location across France |
Drugs / interventions tested
- Atorvastatin (atorvastatin) — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
- Normocholesterolaemic Men — all drugs for Normocholesterolaemic Men →
- Normozoospermic Men — all drugs for Normozoospermic Men →
Sponsor
University Hospital, Clermont-Ferrand
Who can join
Adults 18 to 65, male only, with Healthy Volunteers or Normocholesterolaemic Men. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Observations of all modifications on semen quality after 5 months of atorvastatin treatment
Time frame: at month 5 -
Observations of all modifications on semen quality after 5 months of atorvastatin treatment and after 3 months after its withdrawal
Time frame: at month 8
Sponsor's own description
Recently, concerns about the effect of atorvastatin intake on men fertility have been raised. However, this statin has never been investigated regarding its influence on male fertility, notably sperm quality. The aim of this pilot study is to evaluate the efficacy and the safety of a decrease of cholesterol blood levels, induced by taking atorvastatin, on sperm quality of normocholesterolaemic and healthy men without confounding factors.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Evaluation of atorvastatin efficacy and toxicity on spermatozoa, accessory glands and gonadal hormones of healthy men: a pilot prospective clinical trial.
Pons-Rejraji H, Brugnon F, Sion B, Maqdasy S, et al · · 2014 · cited 28× · PMID 25016482 · DOI 10.1186/1477-7827-12-65
Verify or expand the search:
- PubMed search for NCT02094313
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Hospital, Clermont-Ferrand trials
Trials by the same sponsor.
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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 NCT02094313 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Clermont-Ferrand
- Last refreshed: 20 March 2014
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/NCT02094313.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing