A multicentre, double blind, randomized, parallel group, clinical trial to compare the sexual pleasure, performance, acceptability and safety of graphene incorporated natural rubber latex condoms and natural rubber latex condoms in healthy humans.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 7
- 主要终点
- 1.Sexual pleasure:Increase in sexual pleasure assessed by 7-point Likert Scale following the use of graphene incorporated natural rubber latex condom versus normal rubber latex condom during each visit.
研究概览
简要总结
This is a multicentre,double blind, randomized clinical trial to compare the sexual pleasure, performance, acceptability and safety of grapheneincorporated natural rubber latex condoms and natural rubber latex condoms inhealthy humans. This is a global study. Total 330 healthy, adult,sexually active, heterosexual couples who are fulfilling inclusion criteria willbe enrolled in the study.
Visit 1 will be screening andrandomization day visit at day -5 to 1. Visit 2 will be interim visit at Firstfive-act of intercourse or Day 30± 2 days whichever earlier. Visit 3 will befollow up visit at Day 90 ± 10 days. Visit 4 will be End of Visit: Day 180 ± 10days. Primary endpoint assessment will be increase in sexual pleasure assessed by7-point Likert Scale following the use. Secondary endpoints assessment will be performanceassessment, acceptability assessment, safety endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy sexually active mutually monogamous heterosexual couples
- •Subject at least 18 years of age, able to provide informed consent.
- •Subject who are willing and able to take part and attend all required clinical trial visits, able to understand the information given to them and give written consent.
- •Subjects are in good health as confirmed by medical history, physical and gynecological examination.
- •Male partner must have used at least one condom during the 12 months prior to the study.
- •Subjects are not currently using any method of contraception other than the condom and are agreeable to getting pregnant during the 6 months study period.
排除标准
- •1.Women who are pregnant or suspected to be pregnant.
- •2.Women who have had a pelvic inflammatory disease, have untreated acute cervicitis or vaginitis, have the history of thrombophlebitis, have known or suspected uterine/cervical and breast malignancy.
- •3.Presence or history of allergy or sensitivity to topical vaginal products latex, or any other investigation products.
- •4.Currently active or a history of recurrent sexually transmitted infection (STI) including human immunodeficiency virus (HIV) infection in one or either partner.
- •5.Multiple sexual partners.
- •6.Participation in a clinical trial in the previous month which could, in the opinion of the investigator, affect the outcome of the investigation.
- •7.Male partners with a known history of erectile or ejaculatory dysfunction or abnormal penile anatomy that would affect the ability to keep the condom in place during intercourse.
- •8.Female partner suffering from vaginal dryness or using medication which would affect vaginal mucosal secretion, such as Chlorpheniramine.
- •9.Use of birth control methods other than the condom as part of the study.
- •10.Male or female partner with genital piercing.
- •11.Male partners using medication that would affect the ability to obtain and maintain an erection to normal ejaculation.
- •12.Male partner with the diagnosis of penile skin condition within previous three months (e.g. conditions associated with balanoposthitis: penile psoriasis, lichen sclerosis, eczema) as confirmed by subject and by genital examination.
结局指标
主要结局
1.Sexual pleasure:Increase in sexual pleasure assessed by 7-point Likert Scale following the use of graphene incorporated natural rubber latex condom versus normal rubber latex condom during each visit.
时间窗: 6 months
次要结局
- 1.Performance assessment:(-Pregnancy rate due to device failure during the 6-month period)