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NCT02612714
Statin Therapy is Associated With Low Testosterone and Sexual Function in Men With Type 2 Diabetes
Phase 4 trial testing Rosuvastatin in Sexual Dysfunction in 151 participants. Completed in 1 December 2014.
1 November 2014
Quick facts
| Lead sponsor | Chang Gung Memorial Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Enrollment | 151 |
| Start date | 1 July 2013 |
| Primary completion | 1 November 2014 |
| Estimated completion | 1 December 2014 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Rosuvastatin (rosuvastatin) — full drug profile →
Conditions studied
- Sexual Dysfunction — all drugs for Sexual Dysfunction →
Sponsor
Chang Gung Memorial Hospital
Who can join
Adults 18 to 75, male only, with Sexual Dysfunction. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
serum testosterone
Time frame: up to 24 weeks
The measure is a composite outcome measure consisting of multiple measures. Serum testosterone measured after 24 weeks statin treatment, after quitted statin for 24 weeks and after 24 weeks of re-administrating statin
Sponsor's own description
Statins may decrease serum testosterone levels via decreasing cholesterol. This longitudinal study detected the effects of rosuvastatin on free testosterone levels and sexual function in men with type 2 diabetes. Methods: Investigator enroll 150 men with type 2 diabetes and hypercholesterolemia. Biochemical assessments include serum total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein, triglyceride, prolactin, thyroid-stimulating hormone, luteinizing hormone, follicle stimulating hormone, total testosterone and serum sex hormone binding globulin (SHBG). All parameters are measured before statin treatment, after 6 months of statin treatment and 6 months after discontinuing statin treatment. Scores of the sexual health inventory for men (SHIM) are also evaluated.
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 NCT02612714
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rosuvastatin
Trials testing the same drug.
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- NCT07515339 — A Study to Learn More About How Safe Nurandociguat is and How it Affects the Way the Body Processes Rosuvastatin and Dab · Phase 1 · not yet recruiting
- NCT07303816 — Statins to Prevent Cancer Associated Blood Clots · Phase 4 · not yet recruiting
- NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
Other recruiting trials for Sexual Dysfunction
Currently open trials in the same condition.
- NCT07413705 — BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and · NA · recruiting
- NCT07104292 — Pelvic Floor Muscle Training During Pregnancy · NA · recruiting
- NCT06541002 — A Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors · NA · recruiting
- NCT06868121 — AYA OMGYES Sexual Health Study · NA · recruiting
- NCT06587841 — Noninvasive Spinal Cord Stimulation for Early SCI · NA · recruiting
Other Chang Gung Memorial Hospital trials
Trials by the same sponsor.
- NCT07419789 — Precision Care for Older Persons · NA · not yet recruiting
- NCT07248345 — Virtual Reality Intervention for Family Caregivers of Persons Living With Dementia · NA · not yet recruiting
- NCT07036978 — Metabolomic and Immune-Microbiome Profiling for Unresectable Pancreatic Cancer · not yet recruiting
- NCT07489833 — Metabolomic Pathways and Traditional Chinese Medicine Body Constitution in Cancer-related Fatigue · not yet recruiting
- NCT07496528 — The ACURE Trial: Acupuncture for Colorectal Recovery · NA · not yet 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 NCT02612714 (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 Chang Gung Memorial Hospital
- Last refreshed: 20 November 2015
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/NCT02612714.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing