- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00857961
A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations
6. januar 2011 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
21
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Tuscon, Arizona, Forenede Stater
- 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, Forenede Stater
- 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, Forenede Stater
- 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, Forenede Stater
- 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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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
Andre navne:
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Eksperimentel: 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
Andre navne:
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Eksperimentel: 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
Andre navne:
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Eksperimentel: 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
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)]
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Adverse Events
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: 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
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2007
Primær færdiggørelse (Faktiske)
1. januar 2008
Studieafslutning (Faktiske)
1. januar 2008
Datoer for studieregistrering
Først indsendt
4. marts 2009
Først indsendt, der opfyldte QC-kriterier
5. marts 2009
Først opslået (Skøn)
9. marts 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. januar 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. januar 2011
Sidst verificeret
1. januar 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14271 (Registry Identifier: IND)
- MTE07 (Anden identifikator: Acrux)
- I5E-MC-TSAG (Anden identifikator: Eli Lilly and Company)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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