None listed
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Natural Latex Female Contraceptive
Condom: Natural Latex Female Contraceptive Condom is a soft pliable rubber latex sheath, which lines the vagina. For Female Co
Sponsors
HLL Lifecare limited
Eligibility
Inclusion criteria
Inclusion criteria: -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.
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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.Timepoint: required sample size is 363. Each couple will use four condoms over one month. The following month,they will come for a follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To observe any discomfort experienced by user/ partner -Burning -Vaginal/Penile Irritation -Itching -Rashes -Allergy 2.To monitor the presence of side effects/adverse events -Urinary tract infection -Mild bleeding or spotting due to improper insertion -Vaginal/Penile infection -Irritation in the genital area 3.Identifying & analyzing emerging risks 4.To observe clinical benefits & ensure continued acceptability of benefit- risk ratio 5.To identify contraindicated scenarios & possible systematic misuse or off-label use of the device 6.User acceptability - product experience & user satisfaction levels.Timepoint: required sample size is 363. Each couple will use four condoms over one month. The following month,they will come for a follow-up. | — |
Countries
India
Contacts
Public ContactDr Roopa Kuchana
Dr. Roopas women health and fertility center
Outcome results
None listed