A prospective, observational, multi-centric, non-randomized PMCF study to evaluate the safety and performance of the Natural Latex Female Contraceptive Condom.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 363
- 试验地点
- 4
- 主要终点
- To confirm the performance of the Natural Latex Female Contraceptive Condom by assessing the total female condom failure, including both clinical and non-clinical failures. Additionally, the goal is to monitor the occurrence of each type of failure event.
研究概览
简要总结
Objectives:
Primary Objectives: The primary objective is to confirm the performance of the Natural Latex Female Contraceptive Condom by assessing the total female condom failure, including both clinical and non-clinical failures. Additionally, the goal is to monitor the occurrence of each type of failure event.
Secondary Objectives:
1.To observe any discomfort experienced by user/ partner
2.To monitor the presence of side effects/adverse events
3.Identifying and analyzing emerging risks
4.To observe clinical benefits and ensure continued acceptability of benefit- risk ratio
5.To identify contraindicated scenarios and possible systematic misuse or off-label use of the device
6.User acceptability – product experience and user satisfaction levels.
Study Population:Required sample size is 363 couple. Each couple will use 4 condoms within a period of one month. In total 1452 use cases will be considered for the final analysis.
Study type
The study will be a prospective, observational, multi-centric, non-randomized, post-market clinical study.
Study design and data collection method
-The subjects who met the inclusion/exclusion criteria and voluntarily agree to participate will be enrolled for the study.
-The purpose and requirements of the study will be explained to the prospective couples and informed consent will be obtained from both the participant and their partner.
-The safety and performance of the product will be assessed using the PMCF checklist to ensure its effective use.
-During the study, more detailed information about sexual activity will be gathered than typically collected during family planning visits.
-Each couple will use four condoms and after each use, a coital log has to be filled which is part of the PMCF checklist to document performance and safety of Natural Latex Female Contraceptive Condom. After using all four condoms, each couple will fill out an acceptability and satisfaction questionnaire, also part of the PMCF checklist, and submit the completed PMCF checklist to the study team.
-Side effects, risks, contraindications or misuse/ off-label use of the product (if any) will be reported in the PMCF checklist.
-In the event of an adverse event (AE) or serious adverse event (SAE) following the use of the product, subjects will be requested to report the event to the doctor immediately. The doctor will assess and report the event as an SAE/AE/ADE, completing the appropriate adverse event/adverse device effect report form. This will then be reported to the sponsor and notified body, if necessary.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Mutually monogamous,current relationship greater than 3months -Already protected from pregnancy,e.g oral contraceptive,intrauterine device,subdermal implant,injectable,patch,male or female sterilization -Sexually active women -Sexually active,sufficient to meet protocol requirements agree to have penile-vaginal intercourse with frequency sufficient to meet protocol requirements -Agree to use only study female condoms during time of participation -Agree not to use male condom when using female condom in a single sex act -Agree not to use drugs or non-study devices that can affect sexual performance -Able to understand instructions for correct use of condoms -No known sexually transmitted infections including HIV/AIDS -Agree to use only lubricant(s) provided by the study -Agree not to wear any genital piercing jewellery while using study condoms -Willing and capable of following requirements of protocol,including willingness to respond to questions about reproductive and contraceptive history and use of condoms during interviews and on self-administered questionnaires.
排除标准
- •He/she is allergic or sensitive to the material(s) of the condoms.
- •Female partner is pregnant or desires to become so while participating in study.
- •Subject knowingly has a sexually transmitted infection.
- •Itinerant persons who cannot be able to complete the study, e.g., Migrant farm workers.
- •Male partner has known erectile or ejaculatory dysfunction.
- •Either partner is using any medications or preparation applied topically or intravaginally to the genitalia other than that supplied for the study.
- •Either partner is an employee of study sponsor or affiliated with clinical research center.
结局指标
主要结局
To confirm the performance of the Natural Latex Female Contraceptive Condom by assessing the total female condom failure, including both clinical and non-clinical failures. Additionally, the goal is to monitor the occurrence of each type of failure event.
时间窗: required sample size is 363. Each couple will use four condoms over one month. | The following month,they will come for a follow-up.
Clinical breakage, clinical slippage, clinical misdirection, clinical invagination are considered to assess the clinical failure events and non-clinical breakage is considered to assess the non-clinical failure events.
时间窗: required sample size is 363. Each couple will use four condoms over one month. | The following month,they will come for a follow-up.
次要结局
- 1.To observe any discomfort experienced by user/ partner(-Burning)
研究者
Dr Roopa Kuchana
Dr. Roopas women health and fertility center