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- Register voor klinische proeven in de VS.
- Klinische proef NCT00857961
A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations
6 januari 2011 bijgewerkt door: Eli Lilly and Company
A Phase II, Randomised, Four-way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered Dose (MD) Lotion® Formulations and Doses in Hypogonadal Men
Testosterone replacement treatment is the most effective way of treating hypogonadism in men.
Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate pharmacokinetics of testosterone MD-Lotion formulations.The study will also assess safety of the product.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
21
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Arizona
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Tuscon, Arizona, Verenigde Staten
- 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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Burbank, California, Verenigde Staten
- 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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Connecticut
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New Britain, Connecticut, Verenigde Staten
- 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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San Antonio, Texas, Verenigde Staten
- 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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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 70 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
Inclusion Criteria:
- Male study participants with a prior documented diagnosis of hypoandrogenism as evidenced by previously documented: Hypothalamic, pituitary or testicular disorder or a Serum testosterone less than or equal to 300 ng/dL
- Were receiving, or in the investigator's opinion were eligible to receive treatment for hypoandrogenism
- Body Mass Index (BMI) less than 35 kg/m^2
- Passed the required laboratory and physical screening tests
- Haemoglobin levels at screening greater than or equal to 13.0 g/dL
- Adequate venous access on left or right arm
- Able to communicate with study staff, understand the study information sheet and sign the written Informed Consent forms; willing to follow and comply with study procedures
Exclusion Criteria:
- Any significant history of allergy and/or sensitivity to the drug products or their excipients, including any history of sensitivity to testosterone and/or sunscreens
- Any clinically significant chronic illness or finding on screening physical exam and/or laboratory testing
- Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal drug absorption
- Men with suspected reversible hypoandrogenism (i.e. due to medications, stress)
Any man in whom testosterone therapy is contraindicated, which included those with:
- Known or suspected carcinoma (or history of carcinoma) of the prostate or symptoms of benign prostatic hyperplasia and/or symptoms of lower urinary obstruction,
- Known or suspected carcinoma (or history of carcinoma) of the breast,
- Severe liver damage i.e. cirrhosis, hepatitis or liver tumours,
- Active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions,
- Significant cerebrovascular or coronary artery disease,
- Known or suspected sleep apnoea,
- Hematocrit > 51%
- Men with clinically significant prostate exam or clinically significant elevated serum prostate specific antigen (PSA) level, or age adjusted reference range of PSA values.
- Current history of drug or alcohol abuse (more than 4 standard drinks per day and/or abnormal liver function tests 3 times the upper limit of the normal range values)
- Men taking concomitant medications that affect sex hormone binding globulin (SHBG) or testosterone concentrations or metabolism, or that were cytochrome P450 inducers or inhibitors, anti-coagulants (warfarin), or diabetic medications (insulin), anti-histamines
- Men involved in sport in which there was screening for anabolic steroids
- Men with uncontrolled diabetes (hemoglobin A1c [HbA1c] greater than or equal to 10%)
- Men taking any Investigational Product, or who had received an Investigational Product within 28 days prior to screening or 5 half-lives (whichever was the longer)
- Any contraindication to blood sampling
- Study participants who planned to have a surgical procedure during the course of the study
- Study participants with a partner of child bearing potential who was not willing to use adequate contraception (i.e. condoms) for the duration of the study
- Study participants whose partners were pregnant
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 3 mL (30 mg) of 1% Testosterone MD-Lotion
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
All study participants are randomized to each of the 4 study treatments.
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Administered Topically
Andere namen:
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Experimenteel: 1.5 mL (30 mg) of 2% Testosterone MD-Lotion
Applied once daily for 7 days to one axilla.
All study participants are randomized to each of the 4 study treatments.
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Administered Topically
Andere namen:
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Experimenteel: 3 mL (60 mg) of 2% Testosterone MD-Lotion
Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
All study participants are randomized to each of the 4 study treatments.
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Administered Topically
Andere namen:
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Experimenteel: 4.5 mL (90 mg) of 2% Testosterone MD-Lotion
Applied once daily for 7 days by three doses to both axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
All study participants are randomized to each of the 4 study treatments.
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Administered Topically
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)
Tijdsspanne: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
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Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.
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Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
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Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Tijdsspanne: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
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Cmax is the maximum observed serum concentration of total testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.
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Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
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Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Tijdsspanne: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
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Cmax is the maximum observed serum concentration of dihydrotestosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.
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Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
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Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)
Tijdsspanne: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
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Cmax is the maximum observed serum concentration of free testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.
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Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
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Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)
Tijdsspanne: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
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Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%.
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Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
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Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]
Tijdsspanne: Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
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Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7.
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Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants With Adverse Events
Tijdsspanne: Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)
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A listing of adverse events is located in the Reported Adverse Events module.
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Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Call 1-877-CTLILLY (1-877-285-4559) or 1-31- Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2007
Primaire voltooiing (Werkelijk)
1 januari 2008
Studie voltooiing (Werkelijk)
1 januari 2008
Studieregistratiedata
Eerst ingediend
4 maart 2009
Eerst ingediend dat voldeed aan de QC-criteria
5 maart 2009
Eerst geplaatst (Schatting)
9 maart 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
7 januari 2011
Laatste update ingediend die voldeed aan QC-criteria
6 januari 2011
Laatst geverifieerd
1 januari 2011
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 14271 (Register-ID: IND)
- MTE07 (Andere identificatie: Acrux)
- I5E-MC-TSAG (Andere identificatie: Eli Lilly and Company)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Testosterone MD-Lotion
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Acrux DDS Pty LtdVoltooid
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Acrux DDS Pty LtdVoltooid
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Eli Lilly and CompanyVoltooidHypogonadismeVerenigde Staten, Australië, Frankrijk, Duitsland, Zweden, Verenigd Koninkrijk
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Eli Lilly and CompanyVoltooidEen proef om de voortdurende huidveiligheid van formuleringen met testosteron MD-lotion te evaluerenHypogonadismeVerenigde Staten
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University Hospital MuensterVoltooid
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Azura OphthalmicsSyneos Health; Cliantha ResearchVoltooidDroge ogen | Meibomse klierdisfunctieCanada, Australië, Nieuw-Zeeland
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Bausch Health Americas, Inc.Dow Pharmaceutical SciencesVoltooidPlaque PsoriasisVerenigde Staten
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Azura OphthalmicsORA, Inc.Nog niet aan het werven
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Bausch Health Americas, Inc.Voltooid
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Erasme University HospitalFonds de la Recherche Scientifique (fnrs)Nog niet aan het werven