Premature EjaculationPhase 2NCT01917006
A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation
A Phase 2 study testing OnabotulinumtoxinA and Normal Saline in people with Premature Ejaculation, run by Allergan at 10 sites in 2 countries.
Trial summary
This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature ejaculation (PE) in male participants. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- OnabotulinumtoxinA and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 7 Aug 2013to 15 Aug 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- History of premature ejaculation
- Stable monogamous sexual relationship with female partner for at least 6 months, and intends to continue with the same partner for the duration of the study
- Participant has ability to follow study instructions and complete study assessment tools
Who cannot join
- Premature ejaculation caused by medical or surgical issues, or is related to stress or other issues (eg, relationship problems)
- Pain with ejaculation
- Planned use of topical penile treatments (eg, anesthetics, herbal treatments) or penile injections during the study
- Prior genital, prostatic or lower urinary tract surgery (other than vasectomy or circumcision)
- Previous or current usage of botulinum toxin therapy of any serotype for any urological condition
- Use of botulinum toxin therapy of any serotype for any nonurological condition (eg, cosmetic, chronic migraine) during the 12 weeks prior to screening, or planned usage during the study
- Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States6 sites
Connecticut Clinical Research Center
Middlebury, Connecticut, 06762
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Manhattan Medical Research
New York, New York, 10016
San Diego Sexual Medicine
San Diego, California, 92120
LA Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
Center for Marital and Sexual Health of South Florida
West Palm Beach, Florida, 33401
United Kingdom4 sites
Celerion
Belfast, BT9 6AD
King's College Hospital
London, SE5 9RJ
Queen Anne Street Medical Center
London, W1G 8HU
St Mary's Hospital
London, W2 1NY
About this study
Official title: An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation
This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature ejaculation (PE) in male participants.
Read the detailed description
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-escalation study to assess a range of doses of OnabotulinumtoxinA for the treatment of male participants with PE. Participants will attend a minimum of 6 or 7 clinic visits and also have 1 or 2 telephone visits. Partners will need to attend a clinic visit during the screening period to provide informed consent and to receive training on measurement and recording of the intravaginal ejaculatory latency time (IELT). Participants will be enrolled in cohorts. Within the first 5 cohorts, 8 participants are to receive OnabotulinumtoxinA and 2 participants to receive placebo. For cohort 6, 12 participants will receive OnabotulinumtoxinA and 12 participants will receive placebo. Participants will receive a single treatment of study medication delivered bilaterally to the bulbospongiosus muscle. The initial OnabotulinumtoxinA total dose in this dose escalation study will be 5 U and the maximum OnabotulinumtoxinA total dose will be 100 U. Upon request and if eligible, participants in cohort 6, will have the option to receive a second injection of OnabotulinumtoxinA (Open-label).
- Conditions
- Premature Ejaculation
- Being tested
- OnabotulinumtoxinA, Normal Saline
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
Also called BOTOX®, Botulinum Toxin Type A
OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
Normal SalineDrug
Placebo (normal saline) injected into specified muscle per protocol on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| OnabotulinumtoxinA Dose 1 | Experimental | OnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1. Receives: Drug: OnabotulinumtoxinA |
| OnabotulinumtoxinA Dose 2 | Experimental | OnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks. Receives: Drug: OnabotulinumtoxinA |
| OnabotulinumtoxinA Dose 3 | Experimental | OnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1. Receives: Drug: OnabotulinumtoxinA |
| OnabotulinumtoxinA Dose 4 | Experimental | OnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1. Receives: Drug: OnabotulinumtoxinA |
| OnabotulinumtoxinA Dose 5 | Experimental | OnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1. Receives: Drug: OnabotulinumtoxinA |
| OnabotulinumtoxinA Dose 6 | Experimental | OnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1. Receives: Drug: OnabotulinumtoxinA |
| Placebo | Placebo comparator | Placebo (normal saline) injected into specified muscle per protocol on Day 1. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the sexual intercourse diary (SID). The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and standard deviation (SD) of log-transformed geometric mean IELTs are then calculated for each treatment group. An Analysis of Covariance (ANCOVA) Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Week 12
Secondary outcomes (2)
Change From Baseline in Average IELT
IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The average of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and SD of average IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline average mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12
Change From Baseline in Geometric Mean IELT
IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and SD of log-transformed geometric mean IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.
Measured: Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study start7 Aug 2013
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
Why it stopped: Strategic business decision was made to terminate the program. There were no safety concerns.
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.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Radecki, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917006
- Sponsor's protocol ID
- 191622-133
- Other IDs
- 2013-001650-94
- Status last verified
- Sep 2018
- First submitted
- 2 Aug 2013
- Last updated
- 18 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of the Safety and Efficacy of BOTOX® for the Treatment of Premature Ejaculation
- ClinicalTrials.gov ID
- NCT01917006
- Acronym / sponsor ID
- 191622-133
- Conditions
- Premature Ejaculation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic business decision was made to terminate the program. There were no safety concerns.
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2013 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Posted 18 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a safety and efficacy study of OnabotulinumtoxinA for the treatment of premature ejaculation (PE) in male participants.
Detailed description
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-escalation study to assess a range of doses of OnabotulinumtoxinA for the treatment of male participants with PE. Participants will attend a minimum of 6 or 7 clinic visits and also have 1 or 2 telephone visits. Partners will need to attend a clinic visit during the screening period to provide informed consent and to receive training on measurement and recording of the intravaginal ejaculatory latency time (IELT). Participants will be enrolled in cohorts. Within the first 5 cohorts, 8 participants are to receive OnabotulinumtoxinA and 2 participants to receive placebo. For cohort 6, 12 participants will receive OnabotulinumtoxinA and 12 participants will receive placebo. Participants will receive a single treatment of study medication delivered bilaterally to the bulbospongiosus muscle. The initial OnabotulinumtoxinA total dose in this dose escalation study will be 5 U and the maximum OnabotulinumtoxinA total dose will be 100 U. Upon request and if eligible, participants in cohort 6, will have the option to receive a second injection of OnabotulinumtoxinA (Open-label).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| OnabotulinumtoxinA Dose 1 | Experimental | Drug: OnabotulinumtoxinAOnabotulinumtoxinA Dose 1 injected into specified muscle per protocol on Day 1. |
| OnabotulinumtoxinA Dose 2 | Experimental | Drug: OnabotulinumtoxinAOnabotulinumtoxinA Dose 2 injected into specified muscle per protocol on Day 1. Participants were eligible for another treatment after 12 weeks. |
| OnabotulinumtoxinA Dose 3 | Experimental | Drug: OnabotulinumtoxinAOnabotulinumtoxinA Dose 3 injected into specified muscle per protocol on Day 1. |
| OnabotulinumtoxinA Dose 4 | Experimental | Drug: OnabotulinumtoxinAOnabotulinumtoxinA Dose 4 injected into specified muscle per protocol on Day 1. |
| OnabotulinumtoxinA Dose 5 | Experimental | Drug: OnabotulinumtoxinAOnabotulinumtoxinA Dose 5 injected into specified muscle per protocol on Day 1. |
| OnabotulinumtoxinA Dose 6 | Experimental | Drug: OnabotulinumtoxinAOnabotulinumtoxinA Dose 6 injected into specified muscle per protocol on Day 1. |
| Placebo | Placebo comparator | Drug: Normal SalinePlacebo (normal saline) injected into specified muscle per protocol on Day 1. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- History of premature ejaculation
- Stable monogamous sexual relationship with female partner for at least 6 months, and intends to continue with the same partner for the duration of the study
- Participant has ability to follow study instructions and complete study assessment tools
Key exclusion criteria (7 listed)
- Premature ejaculation caused by medical or surgical issues, or is related to stress or other issues (eg, relationship problems)
- Pain with ejaculation
- Planned use of topical penile treatments (eg, anesthetics, herbal treatments) or penile injections during the study
- Prior genital, prostatic or lower urinary tract surgery (other than vasectomy or circumcision)
- Previous or current usage of botulinum toxin therapy of any serotype for any urological condition
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 |
|---|---|---|
| OnabotulinumtoxinAAlso: BOTOX®, Botulinum Toxin Type AOnabotulinumtoxinA injected into specified muscle per protocol on Day 1. | Drug | OnabotulinumtoxinA Dose 1, OnabotulinumtoxinA Dose 2, OnabotulinumtoxinA Dose 3, OnabotulinumtoxinA Dose 4, OnabotulinumtoxinA Dose 5, OnabotulinumtoxinA Dose 6 |
| Normal SalinePlacebo (normal saline) injected into specified muscle per protocol on Day 1. | Drug | Placebo |
Primary outcome
Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
Time frame: Baseline (Day 1) to Week 12
IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the sexual intercourse diary (SID). The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and standard deviation (SD) of log-transformed geometric mean IELTs are then calculated for each treatment group. An Analysis of Covariance (ANCOVA) Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.
2 secondary outcomes
Change From Baseline in Average IELT
Time frame: Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12
Change From Baseline in Geometric Mean IELT
Time frame: Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel Radecki study director
Allergan
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OnabotulinumtoxinA and Normal Saline in people with Premature Ejaculation, run by Allergan at 10 sites in 2 countries.
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 7 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: stopped early, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, United Kingdom. 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 18 Oct 2018). 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 Intravaginal Ejaculatory Latency Time (IELT) (time frame: Baseline (Day 1) to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.