None listed
Conditions
Interventions
Intervention1: Graphene incorporated natural rubber latex condoms.: Few layers of graphene incorporated in the natural rubber latex condom
Control Intervention1: Natural rubber latex condoms: Normal n
Sponsors
HLL Lifecare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy sexually active mutually monogamous heterosexual couples 2. Subject at least 18 years of age, able to provide informed consent. 3. 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. 4. Subjects are in good health as confirmed by medical history, physical and gynecological examination. 5. Male partner must have used at least one condom during the 12 months prior to the study. 6. 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Performance assessment: -Pregnancy rate due to device failure during the 6-month period -Clinical breakage, Nonclinical breakage, -Total breakage, -Complete slippage, -Total failure 2.Acceptability assessment: -Acceptability questionnaire 3.Safety endpoints -Physical examination -Gynecological examination of female and male genital examination -Adverse events, including irritation, sensitization etc. to vaginal mucous and penis -Serious adverse event Timepoint: 6 Months | — |
Countries
India, Nigeria, South Africa
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Services
Outcome results
None listed