Phase
Condition
N/ATreatment
Control NRL condom
Test condom A (NRL condom with 5% benzocaine paste)
Test condom B (NRL condom with 3% benzocaine paste)
Clinical Study ID
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Main Inclusion Criteria:
Subjects and their female partners have provided written informed consent.
Subjects and their female partners between the ages of >= 18 years and =< 60 years.
Subjects and their female partners must have no health condition in their medicalhistory.
Subject must be sexually active having regular intercourse.
Subjects in a stable, monogamous, sexual relationship with the same female partnerfor more than or equal to 3 months.
Subject's female partner should already be on an established other highly effectiveform of non-barrier contraception, unless post-menopausal.
Subjects reporting a frequency of 'occasionally' to the Sexual IntercourseSelf-Estimation Scale.
Exclusion
Main Exclusion Criteria:
Subject with a pregnant or breastfeeding female partner or the female partnerdesires to become pregnant during the clinical investigation.
Subject or his female partner with a current history of alcohol or drug abuse.
Subjects and their female partners with a history of or are suffering from anemia,coronary artery disease, impaired cardiac conduction, pulmonary disease, diabetes,and renal or hepatic disease.
Subjects and their female partners with a history of, suspected to have, or be atincreased risk of methaemoglobinemia / complications related to ester anaestheticswhich could trigger methemoglobinemia.
Subject and/or his female partner have a physical or psychological condition thatwould prevent them from following investigation procedures - including but notlimited to the following:
urological disease,
ongoing significant psychiatric disorder not controlled by medication
history of surgery or injury to the pelvis, retroperitoneal surgery,radiotherapy, multiple sclerosis, spinal cord injury, chronic inflammation ofthe prostate or urethra
relevant previous or planned genital surgery
female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness)
any broken skin or wounds in the genital area.
Subjects on medication that is contraindicated, which may affect erection.
Subject and/or his female partner have any medication which may affect the safety ofthe subject, including but not limited to benzocaine drug interactions such ascholinesterase inhibitors.
Subject and/or his female partner is using or intends to continue to use antibioticsof the sulphonamide type.
Subject with premature ejaculation, erectile dysfunction, hypo or hyperthyroidism,hypogonadism, hyperprolactinemia, ejaculatory dysfunction, haemorrhagic disorder,hepatitis B or C, human immunodeficiency virus (HIV) infection or having had penileimplant surgery.
Subject that has been diagnosed or received treatment for PE (prematureejaculation).
Subjects with confirmed erectile dysfunction, hypo or hyperthyroidism, hypogonadism,hyperprolactinemia.
Confirmed diagnosis of male subjects with other forms of ejaculatory dysfunction.
Subjects that have had prior genital, prostatic or lower tract surgery.
Subjects with haemorrhagic disorder, hepatitis B or C, HIV infection or having hadpenile implant surgery, at any time in their past.
Either partner needed to use condoms for a specific STI protection.
Subjects and their female partners who have any relevant history of allergyincluding local anaesthetics, parabens, PABA, commercial hair dyes,paraphenylenediamine, lubricants and latex.
Study Design
Study Description
Connect with a study center
SGS proderm GmbH
Hamburg,
GermanyActive - Recruiting
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