Effect of Tadalafil Once a Day in Men With Erectile Dysfunction
15 december 2010 uppdaterad av: Eli Lilly and Company
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Efficacy and Safety of Tadalafil (LY450190) Once a Day in Subjects With Erectile Dysfunction Who Are Naïve to PDE5 Inhibitors
The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors.
Patients may be dose reduced to 2.5mg based on tolerability.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
217
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Athens, Grekland, 11527
- 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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Patras, Grekland, 26500
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Thessaloniki, Grekland, 56429
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Catania, Italien, 95100
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Firenze, Italien, 50139
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L Aquila, Italien, 67100
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Milano, Italien, 20132
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Rome, Italien, 00100
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Bialystok, Polen, 15-223
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Legionowo, Polen, 05-120
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Lodz, Polen, 91-425
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Warsaw, Polen, 00-631
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Aravaca, Spanien, 28023
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Barcelona, Spanien, 08025
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Madrid, Spanien, 28040
- 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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Majadahonda, Spanien, 28222
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Bad Wiessee, Tyskland, D-83707
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Berlin, Tyskland, 13465
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Hamburg, Tyskland, 20354
- 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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Koblenz, Tyskland, D-56068
- 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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Leipzig, Tyskland, 04109
- 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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
- You are male and aged at least 18 years.
- Have a history of erectile dysfunction (ED)(defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration.
- Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
- You agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication
- Your entry laboratory test results and medical tests meet study requirements
- You agree to use the study drug only as instructed by your study doctor and staff and to return any unused study drug and containers at the end of the study or as otherwise instructed by the study doctor.
- If currently using cholesterol lowering medications (for example: statins) or medications to lower blood pressure (example: angiotensin-converting enzyme (ACE) inhibitors or calcium channel blocker medications), you need to be on a stable dose and you and your study doctor do not expect any dose change during the study.
Exclusion Criteria:
- You have received previous or current treatment with tadalafil or any other PDE5 inhibitor.
- Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g. Avodart®).
- You have had significant heart disease as determined by your doctor in charge of this study or a member of the doctor's staff.
- Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months.
- Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: Placebo
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tablet administered orally once a day for 12 weeks.
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Experimentell: Tadalafil
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5 milligrams (mg) administered orally once a day for 12 weeks
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
Tidsram: Baseline, Week 12
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Self-reported erectile function over the past 4 weeks.
Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF).
Total Erectile Function Domain scores range from 0 to 30.
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Baseline, Week 12
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Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
Tidsram: Baseline, Week 12
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Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. "Were you able to insert your penis into your partner's vagina?"
Data are presented as the mean percentage of yes responses per participant.
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Baseline, Week 12
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Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses
Tidsram: Baseline, 12 weeks
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Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. "Did your erection last long enough for you to have successful intercourse?"
Data are presented as the mean percentage of yes responses per participant.
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Baseline, 12 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night
Tidsram: Baseline, Week 12
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NPT was measured using electrobioimpedance volumetric assessment (NEVA).
The NEVA device measures a man's erections during the night.
The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up).
Data are entered for the 2 nights prior to the visit.
During the night the man may have multiple erections.
The number of erections is recorded.
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night
Tidsram: Baseline, Week 12
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NPT was measured using electrobioimpedance volumetric assessment (NEVA).
The NEVA device measures a man's erections during the night.
The duration of erections are measured and recorded.
Data presented are the duration of erectile events at baseline and the change from baseline to Week 12.
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change
Tidsram: Baseline, Week 12
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NPT was measured using electrobioimpedance volumetric assessment (NEVA).
The NEVA device measures a man's erections during the night.
The percent of volume change of the penis during erections is measured and recorded for each erection.
Data presented are mean percentage of volumetric change from baseline to Week 12.
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary
Tidsram: Baseline, 12 weeks
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The morning erection diary allows the participant to record whether he experienced an erection on waking.
The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods.
The percentage of mornings the participant reported an erection is analysed.
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Baseline, 12 weeks
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The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint
Tidsram: Week 12
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The subject questionnaire consists of 11 questions.
Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction).
The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction).
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Week 12
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Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire
Tidsram: Baseline, Week 12
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SEAR measures improvement in self-esteem and relationship satisfaction.
Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14).
All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always.
Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items.
Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale.
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)
Tidsram: Baseline, Week 12
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Self-reported overall satisfaction over the past 4 weeks.
Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD)
Tidsram: Baseline, 12 weeks
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Self-reported overall satisfaction over the past 4 weeks.
Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.
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Baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS)
Tidsram: Baseline, Week 12
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Self-reported intercourse satisfaction over the past 4 weeks.
Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS)
Tidsram: Baseline, 12 weeks
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Self-reported overall satisfaction over the past 4 weeks.
Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.
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Baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses
Tidsram: Baseline, 12 weeks
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Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 1. "Were you able to achieve at least some erection (some enlargement of the penis)?
" Data are presented as the mean percentage of yes responses per participant.
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Baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses
Tidsram: Baseline, 12 weeks
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Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4. "Were you satisfied with the hardness of your erection?"
Data are presented as the mean percentage of yes responses per participant.
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Baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses
Tidsram: Baseline, 12 weeks
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Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5. "Were you satisfied overall with this sexual experience?"
Data are presented as the mean percentage of yes responses per participant.
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Baseline, 12 weeks
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Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint
Tidsram: Week 12
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GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study.
Responses range from 1=very much better to 7=very much worse.
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Week 12
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Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint
Tidsram: Week 12
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GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study.
Responses range from 1=very much better to 7=very much worse.
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Week 12
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Call 1-877-CTLILLY(1-877-285-459) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM eastern time (UTC/GMT -5 hours, EST), Eli Lilly and Company
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.
- Porst H, Brock GB, Kula K, Moncada I, Montorsi F, Basson BR, Kinchen K, Aversa A. Effects of once-daily tadalafil on treatment satisfaction, psychosocial outcomes, spontaneous erections, and measures of endothelial function in men with erectile dysfunction but naive to phosphodiesterase type 5 inhibitors. J Androl. 2012 Nov-Dec;33(6):1305-22. doi: 10.2164/jandrol.111.015289. Epub 2012 Jul 12.
- Montorsi F, Aversa A, Moncada I, Perimenis P, Porst H, Barker C, Shane MA, Sorsaburu S. A randomized, double-blind, placebo-controlled, parallel study to assess the efficacy and safety of once-a-day tadalafil in men with erectile dysfunction who are naive to PDE5 inhibitors. J Sex Med. 2011 Sep;8(9):2617-24. doi: 10.1111/j.1743-6109.2011.02353.x. Epub 2011 Jun 27.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2009
Primärt slutförande (Faktisk)
1 januari 2010
Avslutad studie (Faktisk)
1 januari 2010
Studieregistreringsdatum
Först inskickad
2 februari 2009
Först inskickad som uppfyllde QC-kriterierna
3 februari 2009
Första postat (Uppskatta)
4 februari 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
4 januari 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 december 2010
Senast verifierad
1 december 2010
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12229 (Company Internal)
- H6D-MC-LVHX (Annan identifierare: Eli Lilly and Company)
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