A prospective, non-randomized clinical study comparing the clinical safety, performance and ejaculatory control effect of benzocaine-containing natural rubber latex male condoms.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- 1.To monitor and document discomfort potentially attributable to the benzocaine-containing condom, including:
研究概览
简要总结
Primary Objective:
To evaluate the effect of benzocaine condoms (8.5% benzocaine gel) on Intravaginal Ejaculatory Latency Time (IELT).
Secondary Objectives:
•To compare the mechanical performance of benzocaine-containing condoms with standard condoms, by assessing:
1.Clinical breakage rates (condom breakage during intercourse)
2.Clinical slippage rates (condom dislodgement during intercourse)
3.Non-clinical breakage and slippage (e.g., during donning, withdrawal, or post-use inspection)
•To assess user-reported outcomes, including:
1.Overall satisfaction with the product
2.Perceived ease of use
3.Sexual experience (including sensation, arousal, and orgasm quality)
4.Willingness to continue or recommend the product
5.To explore potential clinical benefits, such as:
6.Enhanced ejaculatory control
7.Reduced performance anxiety
8.Improved partner sexual satisfaction (if assessed).
Number of subjects-
The clinical study is designed to include a total of 480 couples, with 240 couples involving circumcised males and 240 involving uncircumcised males.
Study Design-
This study is designed as a prospective, interventional, multi-centric, non-randomized, open-label, single-arm comparative clinical study designed to evaluate the effect of benzocaine-containing condoms (8.5% benzocaine gel) on intravaginal ejaculatory latency time (IELT), along with their safety, performance and user acceptability.
Heterosexual couples meeting the eligibility criteria will be enrolled upon obtaining informed consent from both the participant and their partner. Participants will be provided with a document titled ’Instructions for Participants’ (Attachment V), which outlines the instructions for use and details of the study.
Participants will have to use a total of 15 condoms, five each of Control Condom A (P53S without Benzocaine), Test Condom B (P53S with 8.5% Benzocaine) and Test Condom C (T56S with 8.5% Benzocaine). The control product will be used first, followed by the test products. There should be an interval of at least 24 hours between the use of each condom.
Participants will be instructed to measure the Intravaginal Ejaculatory Latency Time (IELT) using a stopwatch or a digital timer (e.g., a smartphone stopwatch application). The female partner shall be responsible for handling the timer. The timer should be started at the moment of vaginal penetration and stopped immediately upon ejaculation. These instructions will be explained to participants prior to study initiation to ensure consistency and reliability in data collection.
After each condom use, participants will fill the coital log which is part of the case report form using a Google Form format. Also, participants will complete an acceptability and satisfaction questionnaire to assess the clinical benefits, user experience, overall satisfaction and willingness to continue or recommend the product. After completing each set of five condoms, participants will visit the investigator. During the visit, the investigator will assess safety-related findings, and any observations will be documented and reviewed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Participants are eligible for inclusion if all of the following criteria are met 1.Male aged 18 to 45 years, circumcised or uncircumcised.
- •2.In a mutually monogamous heterosexual relationship of at least 3 months duration.
- •3.Engaged in regular penile-vaginal sexual activity sufficient to meet protocol-defined minimum coital frequency.
- •4.Willing to have penile-vaginal intercourse using only study-provided condoms for the duration of the study.
- •5.Partner is currently using a reliable method of contraception (e.g oral contraceptive pills intrauterine device contraceptive patch or injection or either partner has undergone sterilization).
- •6.Willing to use only the lubricants provided by the study.
- •7.Willing to avoid the use of drugs medications, or non-study devices that may affect sexual performance during the study period.
- •8.Able to understand and follow instructions regarding correct condom usage and study protocol.
- •9.Willing to remove any genital piercing jewelry prior to condom use during the study period.
- •10.No known sexually transmitted infections STIs including HIV/AIDS at baseline.
- •11.Willing and able to provide informed consent, participate in interviews and complete self-administered questionnaires.
- •12.Available for follow-up throughout the study duration.
排除标准
- •Participants will be excluded from the study if any of the following conditions apply (to either participant or partner) 1.Known allergy or sensitivity to any components of the test or control condoms including natural rubber latex or benzocaine.
- •2.Known hypersensitivity to local anesthetics of the ester type including procaine, lidocaine, tetracaine, or other caine drugs.
- •3.Presence of any of the following medical conditions i Heart arrhythmias ii Methemoglobinemia (history or predisposition) iii Glucose-6-phosphate dehydrogenase (G6PD) deficiency iv Chronic Obstructive Pulmonary Disease (COPD), emphysema, or coronary artery disease 4.Pregnancy or desire to become pregnant during the study period (female partner).
- •5.Known sexually transmitted infection in the male or female partner at the time of enrolment 6.Male partner has known erectile dysfunction Male partner has known ejaculatory dysfunction like delayed ejaculation (difficulty or delay to ejaculate despite adequate stimulation and arousal) retrograde ejaculation (semen flows backward into the bladder instead of out through the urethra) anorgasmia or anejaculation (complete absence of ejaculation) 7.Participants engaging in penile-oral sex or penile-anal sex during the study period 8.Participants using any oral supplements or topical treatments on the penis intended to delay ejaculation.
- •9.Either partner is a commercial sex worker.
- •10.Participants with itinerant lifestyles or occupations (e.g. migrant workers) that prevent completion of the study.
- •11.Use of any topical or intravaginal medication/preparation applied to the genitalia (except study-provided materials).
- •12.Either partner is an employee of the study sponsor or otherwise affiliated with the clinical research center.
结局指标
主要结局
1.To monitor and document discomfort potentially attributable to the benzocaine-containing condom, including:
时间窗: Three follow-up visits: | 1.Visit 1: After using five control condoms (A) | 2.Visit 2: After using the 1st five study condoms (B or C) | 3.Visit 3: After using the 2nd five study condoms (C or B)
oLocal side effects: Pain, stinging or burning sensation, constriction/tightness, tingling
时间窗: Three follow-up visits: | 1.Visit 1: After using five control condoms (A) | 2.Visit 2: After using the 1st five study condoms (B or C) | 3.Visit 3: After using the 2nd five study condoms (C or B)
oDermatological reactions: skin irritation, erythema, rash, swelling, genital itching, dryness
时间窗: Three follow-up visits: | 1.Visit 1: After using five control condoms (A) | 2.Visit 2: After using the 1st five study condoms (B or C) | 3.Visit 3: After using the 2nd five study condoms (C or B)
oSystemic reactions: dizziness, drowsiness (especially with prolonged exposure)
时间窗: Three follow-up visits: | 1.Visit 1: After using five control condoms (A) | 2.Visit 2: After using the 1st five study condoms (B or C) | 3.Visit 3: After using the 2nd five study condoms (C or B)
oPartner-related effects: numbness in partner’s genital area
时间窗: Three follow-up visits: | 1.Visit 1: After using five control condoms (A) | 2.Visit 2: After using the 1st five study condoms (B or C) | 3.Visit 3: After using the 2nd five study condoms (C or B)
次要结局
- To evaluate the incidence of adverse events, including:(oAllergic reactions: latex or benzocaine hypersensitivity, including urticaria or anaphylaxis)
研究者
Dr M Gopinath
Sudha Hospitals,Erode,Tamil Nadu