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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Three 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 | 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IX-01 400 mg | Drug | IX-01 400 mg caplet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Last 4 weeks of treatment compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Last 4 weeks of treatment compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Clinical Research Inc | Mobile | Alabama | 36608 | United States | ||
| Radiant Research, Inc. - Phoenix SE |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31351660 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity |
| FG001 | IX-01 400 mg | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2017 |
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| Drug |
Placebo caplet(s) |
|
| IX-01 800 mg | Drug | IX-01 800 mg (Two 400 mg caplets) |
|
| IX-01 1200 mg | Drug | IX-01 1200 mg (Three 400 mg caplets) |
|
| 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. | 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. | 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'. | 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'. | 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). | 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). | 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. | Last 4 weeks of treatment compared to baseline |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Desert Clinical Research, LLC - Radiant | Mesa | Arizona | 85213 | United States |
| Family Practice Specialists - Radiant | Phoenix | Arizona | 85018 | United States |
| San Diego Sexual Medicine | San Diego | California | 92120 | United States |
| Columbine Family Practice - Radiant | Littleton | Colorado | 80128 | United States |
| South Florida Medical Research Inc. | Aventura | Florida | 33180 | United States |
| A G A Clinical Trials | Hialeah | Florida | 33012 | United States |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | United States |
| Center for Marital and Sexual Health of South Florida | West Palm Beach | Florida | 33401 | United States |
| Northwest Behavioral Research Center | Roswell | Georgia | 30076 | United States |
| Boston Clinical Trials Inc | Boston | Massachusetts | 02131 | United States |
| Mens Health Boston | Chestnut Hill | Massachusetts | 02467 | United States |
| Center For Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| Clifford J Molin MD LTD - Radiant | Las Vegas | Nevada | 89128 | United States |
| Accumed Research Associates | Garden City | New York | 11530-1664 | United States |
| Drug Trials America | Hartsdale | New York | 10530 | United States |
| Manhattan Medical Research | New York | New York | 10016 | United States |
| Radiant Research, Inc. - Akron | Akron | Ohio | 44311 | United States |
| Radiant Research, Inc. - Cincinnati | Cincinnati | Ohio | 45236 | United States |
| Radiant Research, Inc. - Columbus | Columbus | Ohio | 43212 | United States |
| Urologic Consultants of Southeastern Pennsylvania | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Miriam Hospital / The Men's Health Center | Providence | Rhode Island | 02906 | United States |
| Radiant Research, Inc. - Anderson | Anderson | South Carolina | 29621 | United States |
| Radiant Research, Inc. - Greer | Greer | South Carolina | 29650 | United States |
| Radiant Research, Inc. - Dallas | Dallas | Texas | 75231 | United States |
| Clinical Trials of Texas Incorporated | San Antonio | Texas | 78229 | United States |
| Radiant Research Inc - San Antonio | San Antonio | Texas | 78229 | United States |
| Radiant Research, Inc. - Salt Lake City | Murray | Utah | 84123 | United States |
| FG002 | IX-01 800 mg | 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 |
| FG003 | IX-01 1200 mg | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity |
| BG001 | IX-01 400 mg | 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 |
| BG002 | IX-01 800 mg | 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 |
| BG003 | IX-01 1200 mg | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Results presented for modified Intent to treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments). | Posted | Least Squares Mean | Standard Error | Seconds | Last 4 weeks of treatment compared to baseline |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Results presented for modified Intent to treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments). | Posted | Least Squares Mean | Standard Error | Fold change | Last 4 weeks of treatment compared to baseline |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Results presented for modified Intent to treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments). | Posted | Number | Proportion of participants | Last 4 weeks of treatment compared to baseline |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments). | Posted | Number | Proportion of participants | Baseline to the end of treatment (approximately 8 weeks) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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'. | Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments). | Posted | Number | Proportion of participants | Baseline to the end of treatment (approximately 8 weeks) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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'. | Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments). | Posted | Number | Proportion of participants | Baseline to the end of treatment (approximately 8 weeks) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments). | Posted | Number | Proportion of participants | Baseline to the end of treatment (approximately 8 weeks) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments). | Posted | Mean | Standard Deviation | score on a scale | Last 4 weeks of treatment compared to baseline |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments). | Posted | Mean | Standard Deviation | score on a scale | Last 4 weeks of treatment compared to baseline |
|
Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity | 0 | 46 | 0 | 46 | 12 | 46 |
| EG001 | IX-01 400 mg | 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 | 0 | 48 | 0 | 48 | 8 | 48 |
| EG002 | IX-01 800 mg | 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 | 0 | 68 | 0 | 68 | 12 | 68 |
| EG003 | IX-01 1200 mg | 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 | 0 | 69 | 0 | 69 | 18 | 69 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Libido increased | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Haematocrit increased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Red blood cell count increased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Red blood cells urine positive | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Joint hyperextension | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Energy increased | General disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
Sponsor may chose to collaborate on authorship, and sponsor's agent has 60-day review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Ixchelsis Limited | 44 (0) 1227-832760 | ian.osterloh@ixchelsis.com |
| Sep 11, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| D003075 | Coitus |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| OG003 |
| IX-01 1200 mg |
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 |
|
|
| OG003 | IX-01 1200 mg | 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 |
|
|
| OG003 | IX-01 1200 mg | 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 |
|
|
| OG003 | IX-01 1200 mg | 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 |
|
|
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 |
| OG003 | IX-01 1200 mg | 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 |
|
|
| OG003 | IX-01 1200 mg | 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 |
|
|
| OG003 | IX-01 1200 mg | 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 |
|
|
| IX-01 1200 mg |
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 |
|
|