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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02232425




Registration number
NCT02232425
Ethics application status
Date submitted
3/09/2014
Date registered
5/09/2014
Date last updated
17/08/2020

Titles & IDs
Public title
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
Scientific title
An 8-Week, Double-Blind, Placebo-Controlled Parallel Group Study to Evaluate the Effect of IX-01 on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Lifelong Premature Ejaculation
Secondary ID [1] 0 0
IX-0103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premature Ejaculation 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IX-01
Treatment: Drugs - Placebo

Experimental: Drug: IX-01 - Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity

Placebo Comparator: Placebo - Two to four capsules administered orally, 1-6 hours prior to sexual activity


Treatment: Drugs: IX-01


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
Timepoint [1] 0 0
Last 4 weeks of treatment compared to baseline
Secondary outcome [1] 0 0
Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale
Timepoint [1] 0 0
Baseline to the end of treatment (approximately 8 weeks)
Secondary outcome [2] 0 0
Proportion of Participants With Greater Than or Equal to (=) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)
Timepoint [2] 0 0
Last 4 weeks of treatment compared to baseline
Secondary outcome [3] 0 0
Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)
Timepoint [3] 0 0
Last 4 weeks of treatment compared to baseline
Secondary outcome [4] 0 0
Mean Change in Score on Control of Timing of Ejaculation
Timepoint [4] 0 0
Last 4 weeks of treatment compared to baseline
Secondary outcome [5] 0 0
Mean Change in Score on Ejaculation-related Personal Distress
Timepoint [5] 0 0
Last 4 weeks of treatment compared to baseline
Secondary outcome [6] 0 0
Proportion of Participants With = 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire
Timepoint [6] 0 0
Baseline to 8 weeks
Secondary outcome [7] 0 0
Proportion of Participants With = 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire
Timepoint [7] 0 0
Baseline to 8 weeks
Secondary outcome [8] 0 0
Proportion of Participants With = 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire
Timepoint [8] 0 0
Baseline to 8 weeks
Secondary outcome [9] 0 0
Proportion of Participants With = 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire
Timepoint [9] 0 0
Baseline to 8 weeks
Secondary outcome [10] 0 0
Proportion of Participants With = 2 Category Increase in Control and = 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure
Timepoint [10] 0 0
Baseline to 8 weeks
Secondary outcome [11] 0 0
Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment
Timepoint [11] 0 0
Baseline to last 4 weeks on treatment
Secondary outcome [12] 0 0
Incidence of Treatment-emergent Adverse Events
Timepoint [12] 0 0
Start of Treatment to end of study (approximately 10 weeks)

Eligibility
Key inclusion criteria
- In stable (= 6 months) heterosexual relationship

- Have life-long (primary) premature ejaculation

- Have premature ejaculation confirmed by Intravaginal Ejaculatory Latency Time (IELT)
less than or equal to (=) 1 minute on = 75% attempts at sexual intercourse

- Meet other aspects of the International Society for Sexual Medicine (ISSM) definition
for lifelong premature ejaculation (PE), including inability to delay ejaculation on
all or nearly all vaginal penetrations and negative personal consequences such as
distress, bother and frustration

- Willing to attempt intercourse at least 4 times during run-in period and at least 8
more times during double-blind part of the study

- Not planning pregnancy with his partner and he is willing to use contraception (unless
not of child-bearing potential, e.g., surgically sterilised)

- Willing to limit use of alcohol on days in which they take study drug (not more than
three drinks, where one drink is defined as a 12 ounce (oz), 360 milliliter (mL)
bottle of beer, a 5 oz (150 mL) glass of wine, or a 1½ oz (45 mL distilled spirits)

- Capable of giving written informed consent
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- An Intravaginal Ejaculatory Latency Time (IELT) value = 2 minutes during run-in period

- Less than (<) 4 attempts at sexual intercourse during run-in (screening may be
extended or patient may be rescreened if there are extenuating circumstances)

- A rating of control of ejaculation as fair, good, or very good on the Premature
Ejaculation Profile (PEP) questionnaire prior to study

- Co-existing Erectile Dysfunction - International Index of Erectile Dysfunction (IIEF)
erectile function domain < 22 during run-in

- Concomitant use of Phosphodiesterase 5 (PDE5) inhibitors, intracavernosal injections,
penile implants, Selective Serotonin Reuptake Inhibitors (SSRI's) or
Serotonin-Norepinephrine Reuptake Inhibitors (SSNRI's), tricyclic antidepressants (for
example (e.g.) clomipramine), monoamine oxidase inhibitors, alpha blockers, 5 alpha
reductase inhibitors (including propecia for hair loss), topical anaesthetics, and/or
tramadol

- History (last 6 months) of use of Botox or similar product to treat premature
ejaculation

- Unwilling to stop other treatments for premature ejaculation (including but not
limited to pharmacological, herbal, multiple condoms, psychosexual treatment, prior
masturbation)

- Other sexual disorder of patient or partner that could interfere with results

- Current active sexually transmitted disease

- Major medical condition of patient that could interfere with ability to have sexual
activity and or require hospital treatment

- Body Mass Index (BMI) > 40 kg/m2

- Participation in a clinical drug trial anytime during the 30 days prior to screening

- Human Immunodeficiency Virus (HIV) or hepatitis B

- History of clinically significant prostate disease

- History of myocardial infarction, coronary bypass surgery, coronary artery
angioplasty, unstable angina, clinically evident congestive heart failure, cardiac
pacemaker, or cerebrovascular accident

- Cardiac arrhythmia: significant cardiac arrhythmia shown on Electrocardiogram (ECG),
or a known or suspected history of significant cardiac arrhythmias within last six
months

- History of congenital QT prolongation and/ corrected QT (QTc) interval > 450
milliseconds (msec) using the Bazett formula

- Mean systolic cuff blood pressure (BP) > 140 millimeter of mercury (mmHg), as assessed
by up to three measurements taken in sequence within 5-10 minutes of last measure

- Mean diastolic cuff BP > 90 mmHg, as assessed by up to three measurements taken in
sequence within 5-10 minutes of the last measure

- Major psychiatric disease or risk of suicidal tendency as assessed by clinical
evaluation and Patient Health Questionnaire (PHQ)-9 and Columbia Suicide Assessment

- PHQ-9 questionnaire total score > 9 and/or score > 0 for question 9 of PHQ-9, and/or
suicidal ideation or behavior as assessed by Columbia Suicide Assessment

- Clinically significant abnormal laboratory function test results (including liver
enzymes > 2 x Upper Limit of Normal (ULN) or bilirubin > 1.5 x ULN)

- Taking Cytochrome P450 3A4 (CYP3A4) inducers, or moderate and potent CYP3A4 inhibitors

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Australian Centre for Sexual Health - Saint Leonards
Recruitment hospital [2] 0 0
Keogh Institute for Medical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ixchelsis Limited
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Carelon Research
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Novotech (Australia) Pty Limited
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
ICON plc
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/Industry
Name [4] 0 0
PHT Corporation
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong
premature ejaculation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02232425
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Email [email protected]
Address 0 0
Ixchelsis Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02232425