A Randomized, Data Analyst-masked, 3-way Cross-over, Pivotal Clinical Investigation to Evaluate the Performance of Two Polyurethane Male Condoms With Different Size and Thickness in Healthy Monogamous Couples During Vaginal Intercourse Compared With a Commercially Available Thin Latex Male Condom.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 598
- 试验地点
- 6
- 主要终点
- Total clinical failure rate of Polyurethane (PU) male (Test condom 1) condom compared to Natural Rubber Latex (NRL) male condom.
研究概览
简要总结
This investigation is designed to evaluate the performance rate of two polyurethane male condoms with different sizes and thicknesses versus a standard natural rubber latex (NRL) male condom.
The purpose of this study is to see how well the experimental condoms perform compared to the latex rubber condom (for example, how often the different condom types break or slip off the penis).
Sponsor also wants to find out how well couples like using the three condom types and whether they experience any problems when using the condoms (for example, irritation or discomfort).
详细描述
In this clinical investigation, new two PU male condoms (test condoms) will be evaluated against a marketed NRL male condom (control condom). This clinical investigation will also evaluate the in-use tolerance of the test and control condoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The clinical investigation is designed to be a data analyst-masked investigation where the data analyst who will perform the data analysis (both CRO and Sponsor staff involved in analysing the data) will not know which condom type couples have been randomised to use in each assessment period.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both partners participating must provide written informed consent.
- •Couples must include a male and female within a heterosexual couple and be between 18 - 60 years of age inclusive.
- •Both partners must be willing to respond to questions about their reproductive and contraceptive history and use of condoms during interviews and respond to self-administered questionnaires as per instructions.
- •Both partners must agree to answer the questions in the condom use questionnaires and two scales as soon as possible and within 2 (+6) hours following each coital act.
- •Both partners must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
- •All couples must be averaging one act of intercourse weekly, agree to have penile-vaginal intercourse with a frequency sufficient to meet CIP requirements (a minimum of 5 coital acts over 5 weeks per assessment period-).
- •The female partner must also use an established (as agreed by the Investigator) other highly effective form of non-barrier contraception, unless post-menopausal (confirmed menopausal prior to screening, amenorrhea for at least 12 months after cessation of exogenous hormone treatment) in which case no second form of contraception is required. Highly effective non-barrier contraception includes oral contraceptive (oestrogen and progestogen or progestogen-only hormonal contraception associated with inhibition of ovulation), intra-uterine device (IUD) or intra-uterine system (IUS), hormonal implant, injectables, patch and or sterilization of at least one partner (i.e., bilateral tubal ligation, vasectomy deemed medically successful).
- •Both partners must be able to understand instructions for correct use of condoms.
- •Both partners must have an adequate level of literacy to understand and to be able to answer the questionnaires.
- •Both partners must agree to use only the investigational condoms during the time of participation.
- •Participants must agree to use the penis measuring kit provided to measure the erect penis at investigation start.
- •Both partners must agree not to use drugs or non-investigational devices that can affect sexual performance.
- •Both partners must have no known sexually transmitted infections including Human Immunodeficiency Virus (HIV) / acquired immune deficiency syndrome (AIDS) (medical history via self-report) (uncomplicated Herpes simplex virus (HSV) and positive Human papillomavirus (HPV) which areis asymptomatic may be included in the investigation study in the opinion of the Investigator).
- •Both partners must agree to use only lubricant(s) provided for the duration of investigation.
- •Both partners must agree not to wear any genital piercing jewellery for the duration of the clinical investigation.
- •Both partners must have no past medical history of any health condition (self-reported) that, in the opinion of the Investigator, would be considered clinically relevant.
- •Couples must have a compatible electronic device with internet access which they are willing to upload questionnaire data to the web-based platform throughout the investigation.
- •Both partners will be available for follow-up.
排除标准
- •Either partner is or becomes aware of an allergy or sensitivity to the ingredients of any of the products, including the test or control condoms or any lubrication products provided.
- •Either partner has been receiving daily treatment for their pre-existing skin condition (for example, severe eczema/psoriasis) within the three months prior to the screening for this study.
- •Female partner that is pregnant or desires to become so while participating in investigation, (females of childbearing potential must have a negative pregnancy test as part of screening).
- •Any couple undergoing any form of fertility treatment such as in-vitro fertilisation.
- •Either partner needs to use condoms for sexually transmitted infection (STI) protection (e.g., discordance for Human Immunodeficiency Virus (HIV) or herpes).
- •Either partner has previous or planned genital surgery that in the opinion of the Investigator would consider the participant unsuitable to participate in the clinical investigation (e.g., laser for abnormal smear).
- •Either partner are commercial sex workers.
- •Either partner are itinerant persons who will be unable to complete the clinical investigation (e.g., migrant farm workers).
- •Couples that in the opinion of the Investigator, would be unable to complete the investigation.
- •Male partners that have known erectile or ejaculatory dysfunction in the past month.
- •Either partner requires to use/ is using medication or preparations that are applied topically to the genitalia area or intravaginally, other than that supplied for the investigation.
- •A female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness) in the previous 3 months which, in the opinion of the Investigator, deems the partner unsuitable for the investigation.
- •Either partner uses any medication which in the investigator's opinion may interfere with the use of condoms.
- •A male partner with abnormal penile anatomy or genital lesion (e.g., balanoposthitis) that would, in the opinion of the Investigator, affect the ability to keep the condom in place during intercourse.
- •Either partner is suffering from any health conditions (self-reported) or any condition which could, in the opinion of the Investigator, affect the outcome of the investigation or affect their safety if they participate.
- •Either partner have participated in a clinical trial in the previous month which could, in the opinion of the Investigator, affect the outcome of the investigation.
- •Either partner is an employee of the investigational Sponsor or affiliated with the clinical research centre (i.e., enrolment of the Investigator, his/ her family members, employees and other dependent persons).
- •Either partner has a recent history of drug/alcohol abuse within the previous 12 months.
- •Either partner has an inability to follow the procedures of the investigation, (e.g., due to language problems, psychological disorders, health conditions such as dementia).
- •Either partner is unable, in the opinion of the Investigator, to fully comply with the investigation requirements.
研究组 & 干预措施
Test Condom 1- Polyurethane (PU) 57 mm
Following randomisation, couples received a carton of Test Condom 1 (polyurethane [PU], 57 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
干预措施: Polyurethane (PU) male condom-Test condom 1- PU 57 mm (Device)
Test Condom 1- Polyurethane (PU) 63 mm
Following randomisation, couples received a carton of Test Condom 2 (polyurethane [PU], 63 mm) for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
干预措施: Polyurethane (PU) male condom-Test condom 2- PU 63 mm (Device)
Control Condom: Natural Rubber Latex (NRL) 57 mm
Following randomisation, couples received a carton of Control condom: Natural Rubber Latex (NRL) 57 mm for its assigned assessment period. The couples were instructed to use at least 5 condoms for penile-vaginal intercourse during the assessment period, which lasted up to five weeks
干预措施: Natural Rubber Latex (NRL) male condom- Control condom (Device)
结局指标
主要结局
Total clinical failure rate of Polyurethane (PU) male (Test condom 1) condom compared to Natural Rubber Latex (NRL) male condom.
时间窗: within 8 hours following each coital act for each condom use
The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 1) compared to the NRL male control condom. Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by participants.
Total clinical failure rate of Polyurethane (PU) male (Test condom 2) condom compared to Natural Rubber Latex (NRL) male condom.
时间窗: within 8 hours following each coital act for each condom use
The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 2) compared to the NRL male control condom. Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by participants.
Total Clinical Failure Rate of Polyurethane (PU) Male (Test Condom 1: PU 57 mm) Condom Compared to Control Condom: Natural Rubber Latex (NRL) 57 mm Male Condom.
时间窗: within 8 hours following each coital act for each condom use
The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 1) compared to the NRL male control condom. Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, reported by participants.
Total Clinical Failure Rate of Polyurethane (PU) Male (Test Condom 2: PU 63 mm) Condom Compared to Control Condom: Natural Rubber Latex (NRL) 57 mm Male Condom.
时间窗: within 8 hours following each coital act for each condom use
The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 2) compared to the NRL male control condom. Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, reported by participants.
次要结局
- Clinical slippage rate of PU Male Test Condom 2 compared to NRL male control condom(within 8 hours following each coital act for each condom use)
- User acceptability of the 2 PU male test condoms (test condom 1 and test condom 2) and the NRL male control condom.(within 8 hours following each coital act for each condom use)
- Clinical slippage rate of PU Male Test Condom 1 compared to NRL male control condom(within 8 hours following each coital act for each condom use)
- Non-clinical breakage rate for each of the PU male condoms (test condom 1 and test condom 2) and the NRL male control condom.(within 8 hours following each coital act for each condom use)
- Non-clinical slippage respectively of each PU male test condom (test condom 1 and test condom 2) and the NRL male control condom.(within 8 hours following each coital act for each condom use)
- Clinical breakage rate of PU Male Test Condom 1 compared to NRL male control condom(within 8 hours following each coital act for each condom use)
- Clinical breakage rate of PU Male Test Condom 2 compared to NRL male control condom(within 8 hours following each coital act for each condom use)
- In-use tolerability of the 2 PU male test condoms (test condom 1 and test condom 2) and the NRL male control condom.(5 weeks for each condom type)
- Clinical Breakage Rate of PU Male Test Condom 1 Compared to NRL Male Control Condom(within 8 hours following each coital act for each condom use)
- Clinical Slippage Rate of PU Male Test Condom 1 Compared to NRL Male Control Condom(within 8 hours following each coital act for each condom use)
- Clinical Breakage Rate of PU Male Test Condom 2 Compared to NRL Male Control Condom(within 8 hours following each coital act for each condom use)
- Clinical Slippage Rate of PU Male Test Condom 2 Compared to NRL Male Control Condom(within 8 hours following each coital act for each condom use)
- Non-clinical Breakage Rate for Each of the PU Male Condoms (Test Condom 1 and Test Condom 2) and the NRL Male Control Condom.(within 8 hours following each coital act for each condom use)
- Non-clinical Slippage Respectively of Each PU Male Test Condom (Test Condom 1 and Test Condom 2) and the NRL Male Control Condom.(within 8 hours following each coital act for each condom use)
- User Acceptability/In-use Tolerability of the 2 PU Male Test Condoms (Test Condom 1 and Test Condom 2) and the NRL Male Control Condom.(within 8 hours following each coital act for each condom use)