Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom

Официальное название

Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom (Phase II Slippage/Breakage Study)

Обзор

This study is a masked (investigators, research staff), two-way crossover, randomized to sequence of use study designed to evaluate the acceptability and functional performance (breakage, slippage) of a silicone lubricated polyisoprene condom and a silicone lubricated natural rubber latex condom.

Подробное описание

Three hundred (300) couples will be enrolled and asked to use five condoms of each of the two types of lubricated condoms to yield a potential sample size of 1500 uses for each type of lubricated condom. To minimize a potential learning effect, couples will be randomly assigned to the sequence of use of each type of lubricated condom.

The primary objective of this study is to examine the slippage, breakage and acceptability of a new polyisoprene male condom compared to a natural rubber latex condom. The study will assess safety in terms of adverse events and user acceptability will be evaluated by comparing physical attributes of the polyisoprene and latex control condoms, as well as perceptions about using the devices.

Вмешательства

• Устройство Silicone Lubricated Synthetic polyisoprine condom
  Synthetic polyisoprene condom are made from softer materials for a more natural feel and increased sensitivity
• Устройство Silicone Lubricated Natural Rubber Latex Condom
  Natural rubber latex condoms are made from natural rubber

Первичные конечные точки

• Total Clinical Failure [Срок оценки: 5 -7 weeks]

Вторичные конечные точки (2)

• Clinical Breakage [Срок оценки: 5 - 7 weeks]
• Clinical Complete Slippage [Срок оценки: 5-7 weeks]

Критерии участия

Критерии включения

• Between the ages of 18 and 45 (inclusive)
• Willing and able to give written or electronic informed consent
• Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms contained either on self-administered questionnaires or interviews
• Be sexually active (defined as averaging one vaginal coital act per week)
• Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
• Willing to use the study products for ten acts of vaginal intercourse within six weeks of study entry
• In a mutually monogamous relationship with their study partner for at least 3 months and be willing to remain mutually monogamous throughout study participation
• Agree not to use any vaginal or sexual lubricant except the product supplied by the study
• Agree not to wear any genital piercing jewelry while using the study condoms
• Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms
• Agree to return any unopened condoms
• Reachable by telephone
• Has home internet access, a valid personal email for each partner, reachable by phone, ability to videoconference and use electronic consent technology
• Male partner agrees to ejaculate during vaginal intercourse
• Willing to provide photo identification-

Критерии исключения

• Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health
• Female partner self-reported as pregnant
• Allergic to natural rubber latex or polyisoprene, or has a history of recurrent adverse events following use of latex or polyisoprene products
• Unable to follow instructions or strictly adhere to the visit schedule
• At significant (high) risk of sexually transmitted infections, including HIV infection, or having a medical history of recurrent, serious sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia)
• Currently using condoms for protection against a known sexually transmitted infection
• Taking any internally applied medication or oral medication to treat a genital condition
• Male partner has had difficulty achieving or maintaining an erection, or achieving ejaculation in the last month under typical circumstances/ conditions.
• Any self-reported genital condition (e.g. itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect use of the study condoms or the ability to interpret study data -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• Essential Access — Berkeley
• Essential Access — Los Angeles

Идентификаторы

NCT: NCT06595836 · TNR-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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