A Study of LY900010 in Erectile Dysfunction
11 marzo 2019 aggiornato da: Eli Lilly and Company
A Study of LY900010 (LY2452473 + Tadalafil) in the Treatment of Men With Erectile Dysfunction
The primary purpose of the study is to compare the efficacy of LY2452473 + tadalafil to tadalafil alone in improving the erectile function (EF) of men with erectile dysfunction (ED) who incompletely respond to tadalafil alone.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
410
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35209
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arizona
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Phoenix, Arizona, Stati Uniti, 85050
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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California
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Glendora, California, Stati Uniti, 91741
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Irvine, California, Stati Uniti, 92618
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Long Beach, California, Stati Uniti, 90806
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Newport Beach, California, Stati Uniti, 92660
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sacramento, California, Stati Uniti, 95825
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Diego, California, Stati Uniti, 92120
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vacaville, California, Stati Uniti, 95688
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Colorado
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Denver, Colorado, Stati Uniti, 80220
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Englewood, Colorado, Stati Uniti, 80113
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Aventura, Florida, Stati Uniti, 33180
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Celebration, Florida, Stati Uniti, 34747
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Coral Springs, Florida, Stati Uniti, 33065
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Jacksonville, Florida, Stati Uniti, 32209
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Plantation, Florida, Stati Uniti, 33317
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Idaho
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Coeur d'Alene, Idaho, Stati Uniti, 83814
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46256
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Iowa
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Des Moines, Iowa, Stati Uniti, 50314
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kansas
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Overland Park, Kansas, Stati Uniti, 66215
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Topeka, Kansas, Stati Uniti, 66606
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Louisiana
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Shreveport, Louisiana, Stati Uniti, 71106
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Michigan
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Troy, Michigan, Stati Uniti, 48084
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
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Saint Louis, Missouri, Stati Uniti, 63141
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89117
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Carolina
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Cary, North Carolina, Stati Uniti, 27511
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Charlotte, North Carolina, Stati Uniti, 28207
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Raleigh, North Carolina, Stati Uniti, 27607
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Salisbury, North Carolina, Stati Uniti, 28144
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oklahoma
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Edmond, Oklahoma, Stati Uniti, 73034
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tennessee
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Knoxville, Tennessee, Stati Uniti, 37920
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Dallas, Texas, Stati Uniti, 75234
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Antonio, Texas, Stati Uniti, 78229
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Bellevue, Washington, Stati Uniti, 98007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Olympia, Washington, Stati Uniti, 98502
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Spokane, Washington, Stati Uniti, 99202
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 45 anni a 70 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Maschio
Descrizione
Inclusion Criteria include:
- Ambulatory men
- History of erectile dysfunction of at least 3 months duration
- History of incomplete response to any phosphodiesterase type 5 inhibitor (PDE5i) at the maximum tolerated dose within the label
- Anticipate having the same female sexual partner throughout the duration of the study
- Are willing and able to make at least 4 sexual intercourse attempts with the female sexual partner during each 4-week segment of the study
- Agree to use birth control during the study and for 60 days after the study, unless the female partner is postmenopausal
- Agree not to use any other erectile dysfunction treatment, including herbal treatment, during the study and for 96 hours after the last dose of study drug
- Screening laboratory tests within normal limits except for testosterone
- Without a language barrier, are reliable and willing to follow study procedures
- Prostate-specific antigen (PSA) less than 10 nanograms per milliliter (ng/ml). Men with PSA greater than 4 and less than 10 ng/ml must have documentation of a negative histological biopsy of carcinoma of prostate within 12 months prior to screening
Exclusion Criteria include:
- History of penile implant
- History of no response to injection therapy for erectile dysfunction
- History of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection
- Exhibit the presence of clinically significant penile deformity in the opinion of the investigator
- History of prior sexual legal convictions
- Bilateral hip replacements
- History of cancer within the previous 5 years, except for excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin
- Chronic stable angina currently treated with long-acting nitrates
- Chronic stable angina requiring treatment with short-acting nitrates within 90 days prior to screening
- Angina occurring during sexual intercourse in the 6 months prior to screening
- Unstable angina within 6 months prior to screening
- Myocardial infarction or coronary artery bypass graft surgery within 90 days prior to screening
- Angioplasty or stent placement within 90 days prior to screening
- Congestive heart failure within 6 months prior to screening
- History of sudden cardiac arrest
- Supraventricular arrhythmia with an uncontrolled ventricular response at rest, or any history of spontaneous or induced sustained ventricular tachycardia, or use an automatic internal cardioverter-defibrillator
- An abnormality in the 12-lead electrocardiogram (ECG) that in the opinion of the investigator places the subject in an unacceptable risk for study participation
- Systolic blood pressure greater than 170 or less than 90 millimeters of mercury (mm Hg) or diastolic blood pressure greater than 100 or less than 50 mm Hg at screening
- Hepatic, renal, human immunodeficiency virus (HIV), or clinically significant active neuropsychiatric disease
- History of central nervous system injuries (including stroke or spinal cord injury) within 6 months prior to screening
- Alcohol intake of 5 units or greater per day (1 unit = 12 ounces beer, 5 ounces wine, or 1.5 ounces of 80-proof distilled spirits)
- Receiving treatment with antiandrogens or 5-alpha reductase inhibitor
- Anabolic steroids, calcitonin, oral bisphosphonates, Vitamin D greater than 50,000 international units per week (IU/week), dehydroepiandrosterone (DHEA), steroidal supplements, nutritional products intended to have weight reduction or performance enhancing effects, herbal supplements within 7 days prior to screening
- Currently treated with a potent cytochrome P450 (CYP) 3A4 inhibitor, such as systemic ketoconazole or ritonavir, or a CYP3A4 inducer such as rifampicin
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 1 milligram (mg) LY2452473 + 5 mg tadalafil
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Administered orally, once daily for 12 weeks
Administered orally, once daily for 12 weeks
Administered orally, once daily for 12 weeks
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Sperimentale: 5 mg LY2452473 + 5 mg tadalafil
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Administered orally, once daily for 12 weeks
Administered orally, once daily for 12 weeks
Administered orally, once daily for 12 weeks
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Sperimentale: 5 mg LY2452473 + placebo
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Administered orally, once daily for 12 weeks
Administered orally, once daily for 12 weeks
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Comparatore attivo: 10 mg tadalafil + placebo
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Administered orally, once daily for 12 weeks
Administered orally, once daily for 12 weeks
Administered orally, once daily for 12 weeks
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Comparatore attivo: 5 mg tadalafil + placebo
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Administered orally, once daily for 12 weeks
Administered orally, once daily for 12 weeks
Administered orally, once daily for 12 weeks
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
Lasso di tempo: Baseline, Week 12
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The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire.
Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence).
IIEF EF domain scores ranged from 1 to 30.
Higher scores denoted better EF.
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Baseline, Week 12
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary
Lasso di tempo: Baseline, Week 12
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The SEP diary was a participant-assessed diary with 5 questions (Q): Q1 (erection achievement), Q2 (successful penetration), Q3 (successful intercourse), Q4 (satisfied with erection), and Q5 (satisfied with sexual experience) for each sexual encounter made over a specified period of time.
SEP Q1 to Q5 scores were determined as a percentage of "Yes" responses to each of the 5 questions out of all sexual attempts recorded during the time period.
A higher percentage of "Yes" responses indicated better EF.
Assessed was the mean change from baseline in the percentage of "Yes" responses to the SEP diary Q1 to Q5.
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value <0.25).
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)
Lasso di tempo: Baseline, Week 12
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Intercourse Satisfaction (IS) domain score: sum of Questions (Q) 6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction).
IS domain score range: 0 to 15; lower scores denoted lower satisfaction.
Orgasmic Function (OF) domain score: sum of Q9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always).
OF domain score range: 0 to 10; lower scores denoted lower OF.
Sexual Desire (SD) domain score: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire).
SD domain score range: 2 to 10; lower scores denoted lower SD.
Overall Satisfaction (OS) domain score: sum of Q13 and Q14, each rated 1 (low/no satisfaction) to 5 (high satisfaction).
OS domain score range: 2 to 10; lower scores denoted lower OS.
Least squares (LS) mean estimated from repeated measures analysis of variance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in the Percentage of Participants Who Return to "Normal" on the International Index of Erectile Function (IIEF) Scale (EF>25)
Lasso di tempo: Baseline, Week 12
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The percentage of participants whose IIEF Erectile Function (EF) domain scores changed from ≤25 at baseline to >25 (normal) at Week 12.
The IIEF EF domain score was the sum of IIEF Question (Q) 1 to Q5 and Q15.
Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence).
IIEF EF domain scores ranged from 1 to 30.
Higher scores denoted better EF.
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups
Lasso di tempo: Baseline, Week 12
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The International Index of Erectile Function (IIEF) EF was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF Self-reported questionnaire.
Q1 to Q5 were rated 0 (low/no erectile function) to 5 (high erectile function) and Q15 was rated 1 (no/low confidence) to 5 (high confidence).
IIEF EF domain scores ranged from 1 to 30.
Higher scores denoted better EF.
Testosterone concentration subgroups were based on optimal baseline testosterone levels (<340 nanograms per deciliter [ng/dL] or ≥340 ng/dL).
The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included terms for treatment group, baseline, and baseline*treatment interaction (if p-value<0.25).
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)
Lasso di tempo: Baseline, Week 12
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The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides
Lasso di tempo: Baseline, Week 12
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The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
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Baseline, Week 12
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Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)
Lasso di tempo: Baseline, Week 12
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The least squares (LS) was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in Fasting Glucose
Lasso di tempo: Baseline, Week 12
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The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in Fasting Insulin
Lasso di tempo: Baseline, Week 12
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Change from baseline to 12 Week endpoint in fasting blood insulin concentration.
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
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Baseline, Week 12
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 ottobre 2010
Completamento primario (Effettivo)
1 novembre 2011
Completamento dello studio (Effettivo)
1 novembre 2011
Date di iscrizione allo studio
Primo inviato
8 luglio 2010
Primo inviato che soddisfa i criteri di controllo qualità
8 luglio 2010
Primo Inserito (Stima)
12 luglio 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 aprile 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 marzo 2019
Ultimo verificato
1 marzo 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 11888
- I4K-MC-GPEC (Altro identificatore: Eli Lilly and Company)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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