Health Condition 1: Z309- Encounter for contraceptive management, unspecified
Conditions
Interventions
Intervention1: CUPID Female Condom version 3: Week 0, week 3 and week 6
Control Intervention1: NA: NONE
Sponsors
Cupid Ltd
Eligibility
Inclusion criteria
Inclusion criteria: The following is a list of recommended criteria for the selection of study women: 1. Women in mutually monogamous; current relationship >= 3 months; 2. Women fulfil CDC criteria (annexure 2)and thereby considered by the investigator as reasonably non-pregnant 3. Already protected from pregnancy, e.g. oral contraceptive, intrauterine device, subdermal implant, injectable, patch, male or female sterilisation; 4. 18 years to 45 years of age; 5. Sexually active, sufficient to meet Clinical Investigation plan requirements; agree to have penile-vaginal intercourse with a frequency sufficient to meet Clinical Investigation plan requirements; 6. Agree to use only study female condoms during the study participation; 7. Female whose male partner agrees not to use a male condom while using the study female condom (by female) in a single sex act; 8. Agree not to use drugs or non-study devices that can affect sexual performance; 9. Able to understand instructions for the correct use of female condoms; 10. No known sexually transmitted infections, including HIV/AIDS; 11. Agree not to wear any genital piercing jewellery while using study condoms; 12. Willing and capable of following requirements of the Clinical Investigation plan, including a willingness to respond to questions about reproductive and contraceptive history and use of condoms during interviews and on self-administered diary; 13. Available for follow-up. 14. The study subjects should have an adequate level of literacy commensurate with the self-administered diary 15. Subjects who can read, write and understand the vernacular languages should be part of this study. 16. Subjects whom Investigator has administered study product as part of the standard of care (SOC) practice and consent has been provided by subject followed by administration of study product on the same day.
Exclusion criteria
Exclusion criteria: The female is excluded from the study if she or her partner has one of the following conditions: 1. He/she is allergic or sensitive to the material(s) of the test or control condoms, 2. The female partner is pregnant or desires to become so while participating in the study, 3. Either partner knowingly has a sexually transmitted infection, 4. An itinerant person who might not be able to complete the study, e.g. migrant workers, 5. The male partner has known erectile or ejaculatory dysfunction, 6. Either partner is using any medications or preparation applied topically or intravaginally to the genitalia, 7. Either partner is an employee of study sponsor or affiliated with a clinical research centre, 8. Commercial Sex Workers (CSWs) 9. Anal sex 10. Active SARS-CoV-2 infection known to patient at the time of enrolment in the study/ patients having signs and symptoms of SARS-CoV-2 infection at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Clinical Failures which is defined as number of female condoms with at least one acute failure event (clinical breakage, slippage, misdirection, invagination, or failure event(s) identified in the risk assessment) that results in potential vaginal exposure to semen and other penile discharge will be the primary endpoint of the study. Any condom that experiences multiple clinical failure events) only counts as a single clinical failure.Timepoint: Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Jatin Soni
Eupraxia Centre For Clinical Excellence LLP
Outcome results
None listed