Premature EjaculationPhase 2NCT03055806
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
A Phase 2 study testing IX-01 400 mg, IX-01 800 mg and IX-01 1200 mg in people with Premature Ejaculation, run by Ixchelsis Limited at 29 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- IX-01 400 mg, IX-01 800 mg and IX-01 1200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 29 sitesUnited States
- Study dates
- 28 Feb 2017to 6 Dec 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Radiant Research, Inc. - Akron
Akron, Ohio, 44311
Radiant Research, Inc. - Anderson
Anderson, South Carolina, 29621
South Florida Medical Research Inc.
Aventura, Florida, 33180
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
Boston Clinical Trials Inc
Boston, Massachusetts, 02131
Radiant Research, Inc. - Phoenix SE
Chandler, Arizona, 85224
Mens Health Boston
Chestnut Hill, Massachusetts, 02467
Radiant Research, Inc. - Cincinnati
Cincinnati, Ohio, 45236
Radiant Research, Inc. - Columbus
Columbus, Ohio, 43212
Radiant Research, Inc. - Dallas
Dallas, Texas, 75231
Accumed Research Associates
Garden City, New York, 11530-1664
Radiant Research, Inc. - Greer
Greer, South Carolina, 29650
Drug Trials America
Hartsdale, New York, 10530
A G A Clinical Trials
Hialeah, Florida, 33012
Center For Pharmaceutical Research
Kansas City, Missouri, 64114
Clifford J Molin MD LTD - Radiant
Las Vegas, Nevada, 89128
Columbine Family Practice - Radiant
Littleton, Colorado, 80128
Desert Clinical Research, LLC - Radiant
Mesa, Arizona, 85213
Coastal Clinical Research Inc
Mobile, Alabama, 36608
Radiant Research, Inc. - Salt Lake City
Murray, Utah, 84123
Manhattan Medical Research
New York, New York, 10016
Family Practice Specialists - Radiant
Phoenix, Arizona, 85018
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Miriam Hospital / The Men's Health Center
Providence, Rhode Island, 02906
Northwest Behavioral Research Center
Roswell, Georgia, 30076
Clinical Trials of Texas Incorporated
San Antonio, Texas, 78229
Radiant Research Inc - San Antonio
San Antonio, Texas, 78229
San Diego Sexual Medicine
San Diego, California, 92120
Center for Marital and Sexual Health of South Florida
West Palm Beach, Florida, 33401
About this study
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)
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.
- Conditions
- Premature Ejaculation
- Being tested
- IX-01 400 mg, Placebo, IX-01 800 mg, IX-01 1200 mg
- Keywords
- Sex, Sexual Dysfunction, IX-01
- Medical subject headings
- Premature Ejaculation, Coitus, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IX-01 400 mgDrug
IX-01 400 mg caplet
PlaceboDrug
Placebo caplet(s)
IX-01 800 mgDrug
IX-01 800 mg (Two 400 mg caplets)
IX-01 1200 mgDrug
IX-01 1200 mg (Three 400 mg caplets)
| Study group | Role | What they receive |
|---|---|---|
| IX-01 1200 mg | Experimental | 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 Receives: Drug: IX-01 1200 mg |
| Placebo | Placebo comparator | Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity Receives: Drug: Placebo |
| IX-01 800 mg | Experimental | 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 Receives: Drug: Placebo; Drug: IX-01 800 mg |
| IX-01 400 mg | Experimental | 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 Receives: Drug: IX-01 400 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Last 4 weeks of treatment compared to baseline
Secondary outcomes (8)
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.
Measured: Last 4 weeks of treatment compared to baseline
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.
Measured: Last 4 weeks of treatment compared to baseline
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.
Measured: Baseline to the end of treatment (approximately 8 weeks)
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'.
Measured: Baseline to the end of treatment (approximately 8 weeks)
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'.
Measured: Baseline to the end of treatment (approximately 8 weeks)
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).
Measured: Baseline to the end of treatment (approximately 8 weeks)
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).
Measured: Last 4 weeks of treatment compared to baseline
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.
Measured: Last 4 weeks of treatment compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start28 Feb 2017
- Primary completion17 Nov 2017
- Study completion6 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ixchelsis Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055806
- Sponsor's protocol ID
- IX-0105
- Status last verified
- Mar 2019
- First submitted
- 14 Feb 2017
- Last updated
- 7 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31351660
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03055806
- Acronym / sponsor ID
- IX-0105
- Conditions
- Premature Ejaculation
- Keywords
- Sex, Sexual Dysfunction, IX-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Ixchelsis LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Posted 7 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IX-01 1200 mg | Experimental | Drug: IX-01 1200 mg1200 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 |
| Placebo | Placebo comparator | Drug: PlaceboThree placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity |
| IX-01 800 mg | Experimental | Drug: Placebo, Drug: IX-01 800 mg800 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 |
| IX-01 400 mg | Experimental | Drug: IX-01 400 mg, Drug: Placebo400 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IX-01 400 mgIX-01 400 mg caplet | Drug | IX-01 400 mg |
| PlaceboPlacebo caplet(s) | Drug | IX-01 400 mg, IX-01 800 mg, Placebo |
| IX-01 800 mgIX-01 800 mg (Two 400 mg caplets) | Drug | IX-01 800 mg |
| IX-01 1200 mgIX-01 1200 mg (Three 400 mg caplets) | Drug | IX-01 1200 mg |
Primary outcome
Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period
Time frame: Last 4 weeks of treatment compared to baseline
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.
8 secondary outcomes
Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline
Time frame: Last 4 weeks of treatment compared to baseline
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
Time frame: Last 4 weeks of treatment compared to baseline
Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire
Time frame: Baseline to the end of treatment (approximately 8 weeks)
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.
Time frame: Baseline to the end of treatment (approximately 8 weeks)
Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 in Ejaculation-related Personal Distress on the Premature Ejaculation Profile (PEP) Questionnaire
Time frame: Baseline to the end of treatment (approximately 8 weeks)
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
Time frame: Baseline to the end of treatment (approximately 8 weeks)
Mean Change From Baseline in Score on Control of Ejaculation
Time frame: Last 4 weeks of treatment compared to baseline
Mean Change From Baseline in Score on Ejaculation-related Personal Distress
Time frame: Last 4 weeks of treatment compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31351660Althof 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IX-01 400 mg, IX-01 800 mg and IX-01 1200 mg in people with Premature Ejaculation, run by Ixchelsis Limited at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period (time frame: Last 4 weeks of treatment compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.