Effect of Tadalafil Once a Day in Men With Erectile Dysfunction
2010年12月15日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
217
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Catania、イタリア、95100
- 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.
-
Firenze、イタリア、50139
- 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.
-
L Aquila、イタリア、67100
- 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.
-
Milano、イタリア、20132
- 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.
-
Rome、イタリア、00100
- 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.
-
-
-
-
-
Athens、ギリシャ、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.
-
Patras、ギリシャ、26500
- 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.
-
Thessaloniki、ギリシャ、56429
- 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.
-
-
-
-
-
Aravaca、スペイン、28023
- 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.
-
Barcelona、スペイン、08025
- 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.
-
Madrid、スペイン、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.
-
Majadahonda、スペイン、28222
- 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.
-
-
-
-
-
Bad Wiessee、ドイツ、D-83707
- 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.
-
Berlin、ドイツ、13465
- 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.
-
Hamburg、ドイツ、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.
-
Koblenz、ドイツ、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.
-
Leipzig、ドイツ、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.
-
-
-
-
-
Bialystok、ポーランド、15-223
- 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.
-
Legionowo、ポーランド、05-120
- 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.
-
Lodz、ポーランド、91-425
- 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.
-
Warsaw、ポーランド、00-631
- 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.
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：プラセボ
|
tablet administered orally once a day for 12 weeks.
|
|
実験的：タダラフィル
|
5 milligrams (mg) administered orally once a day for 12 weeks
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
時間枠：Baseline, Week 12
|
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.
|
Baseline, Week 12
|
|
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
時間枠：Baseline, Week 12
|
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.
|
Baseline, Week 12
|
|
Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses
時間枠：Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night
時間枠：Baseline, Week 12
|
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.
|
Baseline, Week 12
|
|
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night
時間枠：Baseline, Week 12
|
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.
|
Baseline, Week 12
|
|
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change
時間枠：Baseline, Week 12
|
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.
|
Baseline, Week 12
|
|
Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary
時間枠：Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
|
The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint
時間枠：Week 12
|
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).
|
Week 12
|
|
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire
時間枠：Baseline, Week 12
|
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.
|
Baseline, Week 12
|
|
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)
時間枠：Baseline, Week 12
|
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.
|
Baseline, Week 12
|
|
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD)
時間枠：Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
|
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS)
時間枠：Baseline, Week 12
|
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.
|
Baseline, Week 12
|
|
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS)
時間枠：Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
|
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses
時間枠：Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
|
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses
時間枠：Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
|
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses
時間枠：Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
|
Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint
時間枠：Week 12
|
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.
|
Week 12
|
|
Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint
時間枠：Week 12
|
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.
|
Week 12
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：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
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年1月1日
一次修了 (実際)
2010年1月1日
研究の完了 (実際)
2010年1月1日
試験登録日
最初に提出
2009年2月2日
QC基準を満たした最初の提出物
2009年2月3日
最初の投稿 (見積もり)
2009年2月4日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年1月4日
QC基準を満たした最後の更新が送信されました
2010年12月15日
最終確認日
2010年12月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。