A Safety and Efficacy Study of OnabotulinumtoxinA in Premature Ejaculation

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).

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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