Back to resultsIX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
Primary Purpose
Premature Ejaculation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IX-01 400 mg
Placebo
IX-01 800 mg
IX-01 1200 mg
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ejaculation focused on measuring Sex, Sexual Dysfunction, IX-01
Eligibility Criteria
Inclusion Criteria:
- Men aged ≥18 years and ≤60 years in stable (≥6 months) heterosexual relationship and who have lifelong PE.
- Premature ejaculation ≤1 minute on ≥75% attempts at sexual intercourse during the run-in period.
- Meets other aspects of ISSM definition.
- Patient and partner willing to attempt intercourse at least 4 times during the run-in period and at least 8 additional times during the double-blind part of the study.
- Partner not planning pregnancy and willing to use contraception (unless not of childbearing potential, e.g, surgically sterilized).
- Willing to limit use of alcohol on days in which he takes study drug.
- Capable of giving written informed consent.
Exclusion Criteria:
- IELT value >2 minutes during the run-in period.
- <4 attempts at sexual intercourse during the run-in period.
- Any patient who rates his control of ejaculation as fair, good, or very good.
- Any patient who rates his ejaculation-related "personal distress" as "not at all" or "a little bit".
- Erectile Dysfunction.
- Concomitant use of phosphodiesterase type 5 (PDE5) inhibitors, selective serotonin reuptake inhibitor (SSRIs)/selective serotonin norepinephrine reuptake inhibitor (SSNRIs), monoamine oxidase inhibitors, alpha blockers, 5-alpha reductase inhibitors, topical anesthetics, and/or tramadol.
- History (last 6 months) of use of Botox or similar product to treat PE.
- Has received IX-01 in a previous clinical study.
- Unwilling to stop other treatments for PE (including but not limited to pharmacological, sex therapy, psychotherapy multiple condoms, and prior masturbation).
- Any other sexual disorder of patient or partner that could interfere with results.
- Any current sexually transmitted disease.
- Any 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 or weight <60 kg.
- Participation in a clinical drug study anytime during the 30 days prior to screening.
- Human immunodeficiency virus (HIV), hepatitis B.
- History of prostate disease or 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.
- Known or suspected history of significant cardiac arrhythmias.
- History of drug-induced allergic reactions including skin reactions.
- Significant psychiatric disease and/or risk of suicidal tendency.
- History of or other evidence of recent alcohol or drug abuse.
Sites / Locations
- Coastal Clinical Research Inc
- Radiant Research, Inc. - Phoenix SE
- Desert Clinical Research, LLC - Radiant
- Family Practice Specialists - Radiant
- San Diego Sexual Medicine
- Columbine Family Practice - Radiant
- South Florida Medical Research Inc.
- A G A Clinical Trials
- Clinical Research Center of Florida
- Center for Marital and Sexual Health of South Florida
- Northwest Behavioral Research Center
- Boston Clinical Trials Inc
- Mens Health Boston
- Center For Pharmaceutical Research
- Clifford J Molin MD LTD - Radiant
- Accumed Research Associates
- Drug Trials America
- Manhattan Medical Research
- Radiant Research, Inc. - Akron
- Radiant Research, Inc. - Cincinnati
- Radiant Research, Inc. - Columbus
- Urologic Consultants of Southeastern Pennsylvania
- Miriam Hospital / The Men's Health Center
- Radiant Research, Inc. - Anderson
- Radiant Research, Inc. - Greer
- Radiant Research, Inc. - Dallas
- Clinical Trials of Texas Incorporated
- Radiant Research Inc - San Antonio
- Radiant Research, Inc. - Salt Lake City
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
IX-01 1200 mg
Placebo
IX-01 800 mg
IX-01 400 mg
Arm Description
1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Outcomes
Primary Outcome Measures
Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period
Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded by the patient or partner using the stopwatch provided.
Secondary Outcome Measures
Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline
Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded using the stopwatch provided.
Proportion of Patients With ≥2.5-fold Increase in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period Compared With Baseline
Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was measured using the stopwatch provided.
Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire
7 point scale ranging from much worse (-3) to much better (3). The proportion refers to the proportion of patients who had the best 2 possible responses [better (2) or much better (3)] on this scale.
Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 on Control of Timing of Ejaculation on the Premature Ejaculation Profile (PEP) Questionnaire.
Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer). A mean change in category of ≥1 or ≥2 corresponds to improving control from 'very poor' to 'fair', 'good', or 'very good'; or from 'poor' to 'fair', 'good', or 'very good'.
Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 in Ejaculation-related Personal Distress on the Premature Ejaculation Profile (PEP) Questionnaire
Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement. A change in category of ≥1 or ≥2 corresponds to improving distress from 'extremely' to 'moderately', 'a little bit' or 'not at all'; or from 'quite a bit' to 'moderately', 'a little bit' or 'not at all'; or from 'moderately' to 'a little bit' or 'not at all'.
Proportion of Patients Achieving Change in Category of ≥2 on Control of Timing of Ejaculation and Achieving Change in Category of ≥1 in Ejaculation-related Personal Distress at End of Treatment
Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer).
Mean Change From Baseline in Score on Control of Ejaculation
Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP question on control of timing is scored on a 5 point scale with the scores ranging from very poor (this is the worst answer scored as 0) to very good (this is the best answer scored as 4).
Mean Change From Baseline in Score on Ejaculation-related Personal Distress
Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
Full Information
NCT ID
NCT03055806
First Posted
February 14, 2017
Last Updated
September 13, 2019
Sponsor
Ixchelsis Limited
1. Study Identification
Unique Protocol Identification Number
NCT03055806
Brief Title
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
Official Title
A Phase 2b, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of 3 Different Dose Levels of IX-01 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (PE)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
November 17, 2017 (Actual)
Study Completion Date
December 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ixchelsis Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Phase 2b, 8-week, double-blind, placebo-controlled, parallel group study to evaluate the effect of 3 different dose levels of IX-01 on IELT and patient-reported outcome in men with lifelong PE.
Men with self-reported lifelong PE (International Society for Sexual Medicine (ISSM) definition) and in stable heterosexual relationship will undergo a 4-week run-in period during which they will be asked to attempt intercourse at least 4 times. Men with IELT ≤ 1 minute on at least 75% of attempts at intercourse during the no-treatment run-in period will be randomized for the double-blind phase of the study.
In the double-blind phase of the study, men will be asked to take study drug 1 to 6 hours prior to sexual activity. Men and partners will be asked to attempt intercourse a minimum of 8 times during the 8 week double-blind study treatment. The patient or partner will record the IELT on each occasion by use of a stopwatch.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
Keywords
Sex, Sexual Dysfunction, IX-01
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IX-01 1200 mg
Arm Type
Experimental
Arm Description
1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Arm Title
IX-01 800 mg
Arm Type
Experimental
Arm Description
800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Arm Title
IX-01 400 mg
Arm Type
Experimental
Arm Description
400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Intervention Type
Drug
Intervention Name(s)
IX-01 400 mg
Intervention Description
IX-01 400 mg caplet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo caplet(s)
Intervention Type
Drug
Intervention Name(s)
IX-01 800 mg
Intervention Description
IX-01 800 mg (Two 400 mg caplets)
Intervention Type
Drug
Intervention Name(s)
IX-01 1200 mg
Intervention Description
IX-01 1200 mg (Three 400 mg caplets)
Primary Outcome Measure Information:
Title
Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period
Description
Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded by the patient or partner using the stopwatch provided.
Time Frame
Last 4 weeks of treatment compared to baseline
Secondary Outcome Measure Information:
Title
Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline
Description
Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded using the stopwatch provided.
Time Frame
Last 4 weeks of treatment compared to baseline
Title
Proportion of Patients With ≥2.5-fold Increase in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period Compared With Baseline
Description
Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was measured using the stopwatch provided.
Time Frame
Last 4 weeks of treatment compared to baseline
Title
Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire
Description
7 point scale ranging from much worse (-3) to much better (3). The proportion refers to the proportion of patients who had the best 2 possible responses [better (2) or much better (3)] on this scale.
Time Frame
Baseline to the end of treatment (approximately 8 weeks)
Title
Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 on Control of Timing of Ejaculation on the Premature Ejaculation Profile (PEP) Questionnaire.
Description
Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer). A mean change in category of ≥1 or ≥2 corresponds to improving control from 'very poor' to 'fair', 'good', or 'very good'; or from 'poor' to 'fair', 'good', or 'very good'.
Time Frame
Baseline to the end of treatment (approximately 8 weeks)
Title
Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 in Ejaculation-related Personal Distress on the Premature Ejaculation Profile (PEP) Questionnaire
Description
Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement. A change in category of ≥1 or ≥2 corresponds to improving distress from 'extremely' to 'moderately', 'a little bit' or 'not at all'; or from 'quite a bit' to 'moderately', 'a little bit' or 'not at all'; or from 'moderately' to 'a little bit' or 'not at all'.
Time Frame
Baseline to the end of treatment (approximately 8 weeks)
Title
Proportion of Patients Achieving Change in Category of ≥2 on Control of Timing of Ejaculation and Achieving Change in Category of ≥1 in Ejaculation-related Personal Distress at End of Treatment
Description
Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer).
Time Frame
Baseline to the end of treatment (approximately 8 weeks)
Title
Mean Change From Baseline in Score on Control of Ejaculation
Description
Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP question on control of timing is scored on a 5 point scale with the scores ranging from very poor (this is the worst answer scored as 0) to very good (this is the best answer scored as 4).
Time Frame
Last 4 weeks of treatment compared to baseline
Title
Mean Change From Baseline in Score on Ejaculation-related Personal Distress
Description
Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.
Time Frame
Last 4 weeks of treatment compared to baseline
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men aged ≥18 years and ≤60 years in stable (≥6 months) heterosexual relationship and who have lifelong PE.
Premature ejaculation ≤1 minute on ≥75% attempts at sexual intercourse during the run-in period.
Meets other aspects of ISSM definition.
Patient and partner willing to attempt intercourse at least 4 times during the run-in period and at least 8 additional times during the double-blind part of the study.
Partner not planning pregnancy and willing to use contraception (unless not of childbearing potential, e.g, surgically sterilized).
Willing to limit use of alcohol on days in which he takes study drug.
Capable of giving written informed consent.
Exclusion Criteria:
IELT value >2 minutes during the run-in period.
<4 attempts at sexual intercourse during the run-in period.
Any patient who rates his control of ejaculation as fair, good, or very good.
Any patient who rates his ejaculation-related "personal distress" as "not at all" or "a little bit".
Erectile Dysfunction.
Concomitant use of phosphodiesterase type 5 (PDE5) inhibitors, selective serotonin reuptake inhibitor (SSRIs)/selective serotonin norepinephrine reuptake inhibitor (SSNRIs), monoamine oxidase inhibitors, alpha blockers, 5-alpha reductase inhibitors, topical anesthetics, and/or tramadol.
History (last 6 months) of use of Botox or similar product to treat PE.
Has received IX-01 in a previous clinical study.
Unwilling to stop other treatments for PE (including but not limited to pharmacological, sex therapy, psychotherapy multiple condoms, and prior masturbation).
Any other sexual disorder of patient or partner that could interfere with results.
Any current sexually transmitted disease.
Any 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 or weight <60 kg.
Participation in a clinical drug study anytime during the 30 days prior to screening.
Human immunodeficiency virus (HIV), hepatitis B.
History of prostate disease or 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.
Known or suspected history of significant cardiac arrhythmias.
History of drug-induced allergic reactions including skin reactions.
Significant psychiatric disease and/or risk of suicidal tendency.
History of or other evidence of recent alcohol or drug abuse.
Facility Information:
Facility Name
Coastal Clinical Research Inc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Radiant Research, Inc. - Phoenix SE
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Desert Clinical Research, LLC - Radiant
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Family Practice Specialists - Radiant
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
San Diego Sexual Medicine
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Columbine Family Practice - Radiant
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80128
Country
United States
Facility Name
South Florida Medical Research Inc.
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
A G A Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Clinical Research Center of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Center for Marital and Sexual Health of South Florida
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Boston Clinical Trials Inc
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Mens Health Boston
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
Center For Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Clifford J Molin MD LTD - Radiant
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Accumed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530-1664
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Manhattan Medical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Radiant Research, Inc. - Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Radiant Research, Inc. - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Radiant Research, Inc. - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Urologic Consultants of Southeastern Pennsylvania
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Miriam Hospital / The Men's Health Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Radiant Research, Inc. - Anderson
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Radiant Research, Inc. - Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Radiant Research, Inc. - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Clinical Trials of Texas Incorporated
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Radiant Research Inc - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Radiant Research, Inc. - Salt Lake City
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31351660
Citation
Althof S, Osterloh IH, Muirhead GJ, George K, Girard N; PEDRIX Multi-Centre Study Group. The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Phase IIb trial (PEDRIX). J Sex Med. 2019 Aug;16(8):1188-1198. doi: 10.1016/j.jsxm.2019.05.015.
Results Reference
derived
Learn more about this trial
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
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