Gender; Premature Ejaculation
Item
Males with primary PE, according to the ISSM Consensus Definition. Defined as, a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and, inability to delay ejaculation on all or nearly all vaginal penetrations; and, negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy
boolean
C0079399 (UMLS CUI [1])
C0033038 (UMLS CUI [2])
Sex behavior
Item
The subject must make at least four attempts at sexual intercourse on four separate days during the untreated run in period.
boolean
C0036864 (UMLS CUI [1])
Ejaculation, Resonse Latency, Time, Intravaginal
Item
The average intravaginal ejaculatory latency time must be < 65 seconds based on the study-provided stop watch assessments.
boolean
C0013746 (UMLS CUI [1,1])
C0242465 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0013746 (UMLS CUI [1,4])
C0442122 (UMLS CUI [1,5])
Hepatitis B surface antigen positive; Hepatitis C antibody positive; HIV antibody positive, Enzyme-Linked Immunosorbent Assay
Item
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result and positive HIV antibody and or confirmatory ELISA test at screening.
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3,1])
C0014441 (UMLS CUI [3,2])
Erectile Dysfunction
Item
Erectile dysfunction (defined as IIEF-EF domain score <22)
boolean
C0242350 (UMLS CUI [1])
total serum testosterone measurement
Item
Subjects who have a serum total testosterone level >25% below the lower limit of normal according to the range of the testing laboratory, when obtained in the morning versus in the afternoon, from screening lab which will need to be evaluated prior to randomization, if an afternoon lab is drawn and the subject meets exclusion criteria a repeat of an am lab is permitted to assess for inclusion in the trial.
boolean
C2210797 (UMLS CUI [1])
Creatinine measurement, serum
Item
Subjects with a clinically significant elevation of serum creatinine outside the country specific normal reference ranges when obtained from a screening lab which will need to be evaluated prior to randomization.
boolean
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement; Alanine aminotransferase measurement
Item
Subject with a clinically significant elevation of AST of > 126 and/or ALT of > 144 when obtained from a screening lab which will need to be evaluated prior to randomization.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Prostate-Specific Antigen
Item
Screening PSA value outside the country specific normal reference ranges.
boolean
C0138741 (UMLS CUI [1])
Thyroid stimulating hormone measurement
Item
TSH outside the country specific normal reference ranges at visit 1.
boolean
C0202230 (UMLS CUI [1])
Free Triiodothyronine Assay
Item
Free Triiodothyronine [T3] outside the country specific normal reference ranges at visit 1.
boolean
C0519160 (UMLS CUI [1])
T4 free measurement
Item
Free Thyroxine T4 outside the country specific normal reference ranges at visit 1.
boolean
C0202225 (UMLS CUI [1])
Grapefruit (food), Consumption of goods; Grapefruit juice, Consumption of goods; Fruit, Citrus, Consumption of goods
Item
Consumption of seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication, and for the duration of the study.
boolean
C0995150 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
C0452456 (UMLS CUI [2,1])
C0009830 (UMLS CUI [2,2])
C0600183 (UMLS CUI [3,1])
C0009830 (UMLS CUI [3,2])
C0452453 (UMLS CUI [3,3])
C0009830 (UMLS CUI [3,4])