Effect of Tadalafil Once a Day in Men With Erectile Dysfunction
2010년 12월 15일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
217
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Athens, 그리스, 11527
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Patras, 그리스, 26500
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Thessaloniki, 그리스, 56429
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Bad Wiessee, 독일, D-83707
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Berlin, 독일, 13465
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Hamburg, 독일, 20354
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Koblenz, 독일, D-56068
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Leipzig, 독일, 04109
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Aravaca, 스페인, 28023
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Barcelona, 스페인, 08025
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Madrid, 스페인, 28040
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Majadahonda, 스페인, 28222
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Catania, 이탈리아, 95100
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Firenze, 이탈리아, 50139
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L Aquila, 이탈리아, 67100
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Milano, 이탈리아, 20132
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Rome, 이탈리아, 00100
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Bialystok, 폴란드, 15-223
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Legionowo, 폴란드, 05-120
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Lodz, 폴란드, 91-425
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Warsaw, 폴란드, 00-631
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약
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tablet administered orally once a day for 12 weeks.
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실험적: 타다라필
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5 milligrams (mg) administered orally once a day for 12 weeks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: 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
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2009년 1월 1일
기본 완료 (실제)
2010년 1월 1일
연구 완료 (실제)
2010년 1월 1일
연구 등록 날짜
최초 제출
2009년 2월 2일
QC 기준을 충족하는 최초 제출
2009년 2월 3일
처음 게시됨 (추정)
2009년 2월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2011년 1월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2010년 12월 15일
마지막으로 확인됨
2010년 12월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 12229 (Company Internal)
- H6D-MC-LVHX (기타 식별자: Eli Lilly and Company)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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