Premature EjaculationNCT02572037
Research and Clinical Value of New Classification for Premature Ejaculation: Multi-Center Research
An observational study of Premature Ejaculation, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 6 sites in China.
Trial summary
An observational study on the effect of new classification for premature ejaculation. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Premature Ejaculation
- How many people
- 568 participants
- Where
- 6 sitesChina
- Study dates
- Oct 2015to 30 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult males with sympton of premature ejaculation, excepting for other diseases.
Who may be able to join
- Male aged between 18 and 60;
- Men in stable heterosexual, monogamous relationships >6 months;
- Symptom of PE: Ejaculation that always or nearly always occurs prior to or within 2 minute of vaginal penetration from the first sexual experience; the inability to delay ejaculation; and negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy.
Who cannot join
- Urinary system infection: Abnormal result of routine urine and prostatic fluid routine examination;
- Abnormal sex hormone: Abnormal result of sex hormone examination;
- Systemic disease: hypertension, diabetes mellitus, alcohol dependence syndrome, coronary heart disease, and Mental disorder;
- Organic disorder: Abnormal palpation of external genitals, testis, epididymis and spermatic cord;
- Drug influence: use of any drug for PE, e.g. SSRI , PDE-5, tramadol, etc;
- Known drug allergy to amide-type local anaesthetics or dapoxetine;
Show all 9Show fewer
- Currently participating, or in the past 30 days quit a another clinical research independent with this research;
- Drugs, alcohol or substance abuse in last 6 months;
- moderate or more severe erectile Dysfunction.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Jingling Hospital
Nanjing, Jiangsu, 210002
Affiliated Zhongda Hospital of Southeast University
Nanjing, Jiangsu, 210009
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, 210029
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
Nanjing, Jiangsu, 210053
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
About this study
Official title: Research and Clinical Value of New Classification for Premature Ejaculation:Multi-Center Research
An observational study on the effect of new classification for premature ejaculation.
Read the detailed description
Premature ejaculation (PE) is one of the the most common male sexual dysfunctions and it has negative impacts on people's quality of life. According to the time that PE syndromes come out, PE is clinically divided to primary PE , which appear from the first sex ,and secondary PE ,which occurred after a period of normal ejaculation. This method of classification make little sense for treatment. In 2008, PE was divided into four types: primary PE, secondary PE, natural variable PE and premature-like ejaculatory dysfunction , and different types of premature ejaculation have their corresponding treatment. Both method of classification are based on the subjective feelings of patients, then whether certain objective test can be used to help diagnosing premature ejaculation? The drug treatment of PE mainly includes local anesthetics and selective 5- serotonin reuptake inhibitor (SSRI), and the selective penile dorsal nerve block is the most used surgery. But the efficacy of dapoxetine(a new SSRI for PE) and local anesthetics is only about 60-70% and 60%, respectively, while the efficacy of surgery is not exact without a standard surgical indication. We suppose that there may be different subtypes of the nerve of patients with premature ejaculation may exist in, which corresponds to a specific treatment.
In previous study, the investigators studied the somatic sensory pathway and autonomic nerve function of patients with premature ejaculation, and found that they were characterized by different neural electrophysiological characteristics. About 60% patients with primary PE show hypersensitivity of penis, and the efficacy of local anesthetics or selective penile dorsal nerve block for them reached 90%. While SSRI can reduce the excitability of the sympathetic nervous system in patients with PE, and the effect of this drug on patients with Sympathetic hyperexcitability is better than those without Sympathetic hyperexcitability. Thus doctors here have already been dividing patients who only suffer from PE(no other diseases mentioned in exclusion criteria)into 4 groups according to the results of nerve electrophysiological examination and give corresponding treatment: 1. Penile sensory hyperexcitability Group, using local anaesthetics(compound lidocaine cream)to treat; 2. Sympathetic hyperexcitability Group: using selective serotonin reuptake inhibitor(SSRI)(Dapoxetine) to treat. 3. Mixed type Group: both Penile sensory hyperexcitability and Sympathetic hyperexcitability: Combined use of two treatments above. 4. Other Group: result of nerve electrophysiological examination is normal: this group of patients will receive further examination to figure out the reason. This pattern of treatment has been used in clinical practice for years.
In this research, the investigators will systemically observe the result of this classification and treatment for 12 weeks. Patients will be asked for participating in this research. The questionnaires(IELT,PEDT,PEP) can be filled in when visited or online about every 4 weeks. If he refused , he would still receive the classified treatment but not enrolled in this research. After treatment of 12 weeks, the investigators will measure the change of IELT, PEDT, PEP, nerve electrophysiological examination and CGIC, then compare the efficacy of the treatment to that has been reported before. If anyone do not want to continue the treatment, he could quit from this research. Software SPSS17.0 will be used for data analysis. The age, height, weight, quantity table, the latency and amplitude of each group will be expressed by the mean add or subtract standard deviation. Quantitative data comparison among groups was analyzed by single factor variance analysis (one-way ANOVA and LSD), comparison of rate using x2 test, comparison of before and after treatment compared with paired t test. P<0.05 showed statistically significant difference.
- Conditions
- Premature Ejaculation
- Keywords
- Premature ejaculation, Dapoxetine, local anaesthetics, nerve electrophysiology
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Penile sensory hyperexcitability: Latencies of GPSEP and/or DNSEP of them are abnormal. They will receive treatment of Compound Lidocaine Cream-a kind of local anaesthetics that is widely used to treat PE. | |
| Group II | Sympathetic hyperexcitability: Latency of PSSR are abnormal.They will be treated with Dapoxetine(Priligy)-a kind of selective serotonin reuptake inhibitor(SSRI) which has been shown effective to PE. | |
| Group III | Mixed type: Both Latencies of GPSEP and/or DNSEP and Latency of PSSR are abnormal.They will receive both Compound Lidocaine Cream and Dapoxetine. | |
| Group IV | Others: Both Latencies of GPSEP, DNSEP and Latency of PSSR are normal.They will receive further tests. (This group is not the main objects to be observed in this study.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Intra-vaginal Ejaculation Latency Time（IELT）
Most commonly used in research on premature ejaculation.
Measured: After enrollment,after 4 weeks' treatment,after 8 weeks' treatment,after 12 weeks' treatment
Change of score of Premature ejaculation diagnostic tool（PEDT）
A questionnaire to evaluate and diagnose premature ejaculation
Measured: After enrollment,after 12 weeks' treatment
Change of grade Premature ejaculation profile（PEP）
A questionnaire consists of 4 questions to evaluate the 4 aspects of the symptom of premature ejaculation
Measured: After enrollment,after 4 weeks' treatment,after 8 weeks' treatment,after 12 weeks' treatment
The change of results of Nerve electrophysiological examination
To measure the penile sensory excitability and penile skin sympathetic excitability.
Measured: After enrollment,after 12 weeks' treatment
Clinical Global Impression of Change
A single question to measure the change after treatment
Measured: After 12 weeks' treatment
Change of Chinese Index of Premature Ejaculation of five items(CIPE-5)
A questionnaire to evaluate and diagnose premature ejaculation designed for Chinese people
Measured: After enrollment,after 12 weeks' treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion1 Jul 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baibing Yang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yutian Dai, Doctor, Study chair, Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572037
- Sponsor's protocol ID
- BL2014001
- Status last verified
- Jul 2019
- First submitted
- 27 Sep 2015
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Waldinger MD. Recent advances in the classification, neurobiology and treatment of premature ejaculation. Adv Psychosom Med. 2008;29:50-69. doi: 10.1159/000126624.
PubMed 18391557Waldinger MD. The neurobiological approach to premature ejaculation. J Urol. 2002 Dec;168(6):2359-67. doi: 10.1016/S0022-5347(05)64146-8.
PubMed 12441918Althof SE, McMahon CG, Waldinger MD, Serefoglu EC, Shindel AW, Adaikan PG, Becher E, Dean J, Giuliano F, Hellstrom WJ, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, Torres LO. An Update of the International Society of Sexual Medicine's Guidelines for the Diagnosis and Treatment of Premature Ejaculation (PE). Sex Med. 2014 Jun;2(2):60-90. doi: 10.1002/sm2.28.
PubMed 25356302Serefoglu EC, McMahon CG, Waldinger MD, Althof SE, Shindel A, Adaikan G, Becher EF, Dean J, Giuliano F, Hellstrom WJ, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, Torres LO. An evidence-based unified definition of lifelong and acquired premature ejaculation: report of the second international society for sexual medicine ad hoc committee for the definition of premature ejaculation. Sex Med. 2014 Jun;2(2):41-59. doi: 10.1002/sm2.27.
PubMed 25356301McMahon CG, Althof SE, Waldinger MD, Porst H, Dean J, Sharlip ID, Adaikan PG, Becher E, Broderick GA, Buvat J, Dabees K, Giraldi A, Giuliano F, Hellstrom WJ, Incrocci L, Laan E, Meuleman E, Perelman MA, Rosen RC, Rowland DL, Segraves R. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine (ISSM) ad hoc committee for the definition of premature ejaculation. J Sex Med. 2008 Jul;5(7):1590-606. doi: 10.1111/j.1743-6109.2008.00901.x.
PubMed 18466262Dinsmore WW, Wyllie MG. PSD502 improves ejaculatory latency, control and sexual satisfaction when applied topically 5 min before intercourse in men with premature ejaculation: results of a phase III, multicentre, double-blind, placebo-controlled study. BJU Int. 2009 Apr;103(7):940-9. doi: 10.1111/j.1464-410X.2009.08456.x. Epub 2009 Feb 23.
PubMed 19245438McMahon CG. Efficacy of dapoxetine in the treatment of premature ejaculation. Clin Med Insights Reprod Health. 2011 Aug 2;5:25-39. doi: 10.4137/CMRH.S7337. eCollection 2011 Aug 2.
PubMed 24453509McMahon CG, Althof SE, Kaufman JM, Buvat J, Levine SB, Aquilina JW, Tesfaye F, Rothman M, Rivas DA, Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. J Sex Med. 2011 Feb;8(2):524-39. doi: 10.1111/j.1743-6109.2010.02097.x. Epub 2010 Nov 8.
PubMed 21059176Xia JD, Zhou LH, Han YF, Chen Y, Wang R, Dai YT. A reassessment of penile sensory pathways and effects of prilocaine-lidocaine cream in primary premature ejaculation. Int J Impot Res. 2014 Sep-Oct;26(5):186-90. doi: 10.1038/ijir.2014.5. Epub 2014 Feb 27.
PubMed 24572995Xia JD, Han YF, Zhou LH, Xu ZP, Chen Y, Dai YT. Sympathetic skin response in patients with primary premature ejaculation. Int J Impot Res. 2014 Jan;26(1):31-4. doi: 10.1038/ijir.2013.23. Epub 2013 May 2.
PubMed 23636274Xia J, Chen T, Chen J, Han Y, Xu Z, Zhou L, Chen Y, Dai Y. The sympathetic skin response located in the penis as a predictor of the response to sertraline treatment in patients with primary premature ejaculation. J Sex Med. 2014 Nov;11(11):2801-8. doi: 10.1111/jsm.12654. Epub 2014 Aug 8.
PubMed 25130949
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research and Clinical Value of New Classification for Premature Ejaculation:Multi-Center Research
- ClinicalTrials.gov ID
- NCT02572037
- Acronym / sponsor ID
- BL2014001
- Conditions
- Premature Ejaculation
- Keywords
- Premature ejaculation, Dapoxetine, local anaesthetics, nerve electrophysiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study on the effect of new classification for premature ejaculation.
Detailed description
Premature ejaculation (PE) is one of the the most common male sexual dysfunctions and it has negative impacts on people's quality of life. According to the time that PE syndromes come out, PE is clinically divided to primary PE , which appear from the first sex ,and secondary PE ,which occurred after a period of normal ejaculation. This method of classification make little sense for treatment. In 2008, PE was divided into four types: primary PE, secondary PE, natural variable PE and premature-like ejaculatory dysfunction , and different types of premature ejaculation have their corresponding treatment. Both method of classification are based on the subjective feelings of patients, then whether certain objective test can be used to help diagnosing premature ejaculation? The drug treatment of PE mainly includes local anesthetics and selective 5- serotonin reuptake inhibitor (SSRI), and the selective penile dorsal nerve block is the most used surgery. But the efficacy of dapoxetine(a new SSRI for PE) and local anesthetics is only about 60-70% and 60%, respectively, while the efficacy of surgery is not exact without a standard surgical indication. We suppose that there may be different subtypes of the nerve of patients with premature ejaculation may exist in, which corresponds to a specific treatment.
In previous study, the investigators studied the somatic sensory pathway and autonomic nerve function of patients with premature ejaculation, and found that they were characterized by different neural electrophysiological characteristics. About 60% patients with primary PE show hypersensitivity of penis, and the efficacy of local anesthetics or selective penile dorsal nerve block for them reached 90%. While SSRI can reduce the excitability of the sympathetic nervous system in patients with PE, and the effect of this drug on patients with Sympathetic hyperexcitability is better than those without Sympathetic hyperexcitability. Thus doctors here have already been dividing patients who only suffer from PE(no other diseases mentioned in exclusion criteria)into 4 groups according to the results of nerve electrophysiological examination and give corresponding treatment: 1. Penile sensory hyperexcitability Group, using local anaesthetics(compound lidocaine cream)to treat; 2. Sympathetic hyperexcitability Group: using selective serotonin reuptake inhibitor(SSRI)(Dapoxetine) to treat. 3. Mixed type Group: both Penile sensory hyperexcitability and Sympathetic hyperexcitability: Combined use of two treatments above. 4. Other Group: result of nerve electrophysiological examination is normal: this group of patients will receive further examination to figure out the reason. This pattern of treatment has been used in clinical practice for years.
In this research, the investigators will systemically observe the result of this classification and treatment for 12 weeks. Patients will be asked for participating in this research. The questionnaires(IELT,PEDT,PEP) can be filled in when visited or online about every 4 weeks. If he refused , he would still receive the classified treatment but not enrolled in this research. After treatment of 12 weeks, the investigators will measure the change of IELT, PEDT, PEP, nerve electrophysiological examination and CGIC, then compare the efficacy of the treatment to that has been reported before. If anyone do not want to continue the treatment, he could quit from this research. Software SPSS17.0 will be used for data analysis. The age, height, weight, quantity table, the latency and amplitude of each group will be expressed by the mean add or subtract standard deviation. Quantitative data comparison among groups was analyzed by single factor variance analysis (one-way ANOVA and LSD), comparison of rate using x2 test, comparison of before and after treatment compared with paired t test. P<0.05 showed statistically significant difference.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | – | –Penile sensory hyperexcitability: Latencies of GPSEP and/or DNSEP of them are abnormal. They will receive treatment of Compound Lidocaine Cream-a kind of local anaesthetics that is widely used to treat PE. |
| Group II | – | –Sympathetic hyperexcitability: Latency of PSSR are abnormal.They will be treated with Dapoxetine(Priligy)-a kind of selective serotonin reuptake inhibitor(SSRI) which has been shown effective to PE. |
| Group III | – | –Mixed type: Both Latencies of GPSEP and/or DNSEP and Latency of PSSR are abnormal.They will receive both Compound Lidocaine Cream and Dapoxetine. |
| Group IV | – | –Others: Both Latencies of GPSEP, DNSEP and Latency of PSSR are normal.They will receive further tests. (This group is not the main objects to be observed in this study.) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult males with sympton of premature ejaculation, excepting for other diseases.
Key inclusion criteria (3 listed)
- Male aged between 18 and 60;
- Men in stable heterosexual, monogamous relationships >6 months;
- Symptom of PE: Ejaculation that always or nearly always occurs prior to or within 2 minute of vaginal penetration from the first sexual experience; the inability to delay ejaculation; and negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy.
Key exclusion criteria (9 listed)
- Urinary system infection: Abnormal result of routine urine and prostatic fluid routine examination;
- Abnormal sex hormone: Abnormal result of sex hormone examination;
- Systemic disease: hypertension, diabetes mellitus, alcohol dependence syndrome, coronary heart disease, and Mental disorder;
- Organic disorder: Abnormal palpation of external genitals, testis, epididymis and spermatic cord;
- Drug influence: use of any drug for PE, e.g. SSRI , PDE-5, tramadol, etc;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of Intra-vaginal Ejaculation Latency Time（IELT）
Time frame: After enrollment,after 4 weeks' treatment,after 8 weeks' treatment,after 12 weeks' treatment
Most commonly used in research on premature ejaculation.
Change of score of Premature ejaculation diagnostic tool（PEDT）
Time frame: After enrollment,after 12 weeks' treatment
A questionnaire to evaluate and diagnose premature ejaculation
Change of grade Premature ejaculation profile（PEP）
Time frame: After enrollment,after 4 weeks' treatment,after 8 weeks' treatment,after 12 weeks' treatment
A questionnaire consists of 4 questions to evaluate the 4 aspects of the symptom of premature ejaculation
The change of results of Nerve electrophysiological examination
Time frame: After enrollment,after 12 weeks' treatment
To measure the penile sensory excitability and penile skin sympathetic excitability.
Clinical Global Impression of Change
Time frame: After 12 weeks' treatment
A single question to measure the change after treatment
Change of Chinese Index of Premature Ejaculation of five items(CIPE-5)
Time frame: After enrollment,after 12 weeks' treatment
A questionnaire to evaluate and diagnose premature ejaculation designed for Chinese people
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Background: PubMed 18391557Waldinger MD. Recent advances in the classification, neurobiology and treatment of premature ejaculation. Adv Psychosom Med. 2008;29:50-69. doi: 10.1159/000126624.
- Background: PubMed 12441918Waldinger MD. The neurobiological approach to premature ejaculation. J Urol. 2002 Dec;168(6):2359-67. doi: 10.1016/S0022-5347(05)64146-8.
- Background: PubMed 25356302Althof SE, McMahon CG, Waldinger MD, Serefoglu EC, Shindel AW, Adaikan PG, Becher E, Dean J, Giuliano F, Hellstrom WJ, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, Torres LO. An Update of the International Society of Sexual Medicine's Guidelines for the Diagnosis and Treatment of Premature Ejaculation (PE). Sex Med. 2014 Jun;2(2):60-90. doi: 10.1002/sm2.28.
- Results publication: PubMed 25356301Serefoglu EC, McMahon CG, Waldinger MD, Althof SE, Shindel A, Adaikan G, Becher EF, Dean J, Giuliano F, Hellstrom WJ, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, Torres LO. An evidence-based unified definition of lifelong and acquired premature ejaculation: report of the second international society for sexual medicine ad hoc committee for the definition of premature ejaculation. Sex Med. 2014 Jun;2(2):41-59. doi: 10.1002/sm2.27.
- Results publication: PubMed 18466262McMahon CG, Althof SE, Waldinger MD, Porst H, Dean J, Sharlip ID, Adaikan PG, Becher E, Broderick GA, Buvat J, Dabees K, Giraldi A, Giuliano F, Hellstrom WJ, Incrocci L, Laan E, Meuleman E, Perelman MA, Rosen RC, Rowland DL, Segraves R. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine (ISSM) ad hoc committee for the definition of premature ejaculation. J Sex Med. 2008 Jul;5(7):1590-606. doi: 10.1111/j.1743-6109.2008.00901.x.
- Results publication: PubMed 19245438Dinsmore WW, Wyllie MG. PSD502 improves ejaculatory latency, control and sexual satisfaction when applied topically 5 min before intercourse in men with premature ejaculation: results of a phase III, multicentre, double-blind, placebo-controlled study. BJU Int. 2009 Apr;103(7):940-9. doi: 10.1111/j.1464-410X.2009.08456.x. Epub 2009 Feb 23.
- Results publication: PubMed 24453509McMahon CG. Efficacy of dapoxetine in the treatment of premature ejaculation. Clin Med Insights Reprod Health. 2011 Aug 2;5:25-39. doi: 10.4137/CMRH.S7337. eCollection 2011 Aug 2.
- Results publication: PubMed 21059176McMahon CG, Althof SE, Kaufman JM, Buvat J, Levine SB, Aquilina JW, Tesfaye F, Rothman M, Rivas DA, Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. J Sex Med. 2011 Feb;8(2):524-39. doi: 10.1111/j.1743-6109.2010.02097.x. Epub 2010 Nov 8.
- Results publication: PubMed 24572995Xia JD, Zhou LH, Han YF, Chen Y, Wang R, Dai YT. A reassessment of penile sensory pathways and effects of prilocaine-lidocaine cream in primary premature ejaculation. Int J Impot Res. 2014 Sep-Oct;26(5):186-90. doi: 10.1038/ijir.2014.5. Epub 2014 Feb 27.
- Results publication: PubMed 23636274Xia JD, Han YF, Zhou LH, Xu ZP, Chen Y, Dai YT. Sympathetic skin response in patients with primary premature ejaculation. Int J Impot Res. 2014 Jan;26(1):31-4. doi: 10.1038/ijir.2013.23. Epub 2013 May 2.
- Results publication: PubMed 25130949Xia J, Chen T, Chen J, Han Y, Xu Z, Zhou L, Chen Y, Dai Y. The sympathetic skin response located in the penis as a predictor of the response to sertraline treatment in patients with primary premature ejaculation. J Sex Med. 2014 Nov;11(11):2801-8. doi: 10.1111/jsm.12654. Epub 2014 Aug 8.
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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.
Yutian Dai, Doctor study chair
Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ejaculation, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 6 sites in China.
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 3 inclusion and 9 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of Intra-vaginal Ejaculation Latency Time（IELT） (time frame: After enrollment,after 4 weeks' treatment,after 8 weeks' treatment,after 12 weeks' treatment). The study lists 6 primary outcomes in all. 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 NCT02572037, which also lists 11 linked publications.
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 19 Jul 2019.