Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201902647164097 Date of Approval: 01/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A study to compare the sexual pleasure, performance, acceptability and safety of graphene incorporated natural rubber latex condoms and natural rubber latex condoms.
Official scientific title 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.
Brief summary describing the background and objectives of the trial This is a multicentre, double blind, randomized 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. This is a global study. Total 330 healthy, adult, sexually active, heterosexual couples who are fulfilling inclusion criteria will be enrolled in the study. Visit 1 will be screening and randomization day visit at day -5 to 1. Visit 2 will be interim visit at First five-act of intercourse or Day 30± 2 days whichever earlier. Visit 3 will be follow up visit at Day 90 ± 10 days. Visit 4 will be End of Visit: Day 180 ± 10 days. Primary endpoint assessment will be increase in sexual pleasure assessed by 7-point Likert Scale following the use. Secondary endpoints assessment will be performance assessment, acceptability assessment, safety endpoint. Primary objective: To evaluate the sexual pleasure of graphene incorporated natural rubber latex condoms during vaginal intercourse in comparison with natural rubber latex condoms. Secondary objective: To assess the device performance, acceptability and safety of graphene incorporated natural rubber latex condoms.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Performance, acceptability and safety of male condom
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/04/2019
Actual trial start date
Anticipated date of last follow up 14/02/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL Not Applicable
Secondary Ids Issuing authority/Trial register
CTRI201812016574 Clinical Trial Registry - India
ECTS17001 Protocol Number
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Graphene incorporated natural rubber latex condoms Everytime during vaginal intercourse for 6 months Few layers of graphene incorporated in the natural rubber latex condom 77
Control Group Natural rubber latex condoms everytime during vaginal intercourse for 6 months Normal natural rubber latex condom 77 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Healthy sexually active mutually monogamous heterosexual couples. 2. Subjects at least 18 years of age, able to provide informed consent. 3. Subjects 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-monthstudy period. 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. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/03/2019 National Health Research Ethics Committee NHREC
Ethics Committee Address
Street address City Postal code Country
Federal Ministry of Health, Federal Secretariat Complex Shehu Shagari Way, Garki, Abuja P.M.B. 083, Garki-Abuja Abuja 900110 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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. baseline, 30 days, 90 days and 120 days
Secondary Outcome 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 Baseline, 30 days, 90 days and 120 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
HICI Healthcare Limited 73A, Lafiaji Way, Dolphin Estate 101222, Ikoyi, Lagos. Lagos 101222 Nigeria
Nigerian Institute of Medical Research NIMR 6, Edmund Crescent, Yaba, Lagos Lagos Nigeria
Center for Bioethics and Research 102, Basorun Road, Ashi, Ibadan, Oyo state. Oyo Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
HLL Lifecare Limited India Corporate R and D Centre Akkulam, Sreekariyam P.O Thiruvananthapuram- 695 017 Kerala, India Thiruvananthapuram 695017 India
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor HLL Lifecare Limited Corporate R and D Centre Akkulam, Sreekariyam P.O Thiruvananthapuram 695 017 Kerala, India Thiruvananthapuram 695017 India Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr.Telufusi Adebukunola Xcene Research, 90b Opebi Road,Ikeja, Lagos, Nigeria, Wonderwheels Lagos 100281 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Clement Adebamowo director@bioethicscenter.net +2348033520571 102, Basorun Road, Ibadan, Oyo State
City Postal code Country Position/Affiliation
Ibadan 200223 Nigeria Principle Investigator
Role Name Email Phone Street address
Scientific Enquiries Milan Satia milansatia@ethicare-cro.com +917940069486 410 to 412, G - Block, Titanium City Centre, 100 Feet Road, Nr. Sachin Tower, Satellite, Ahmedabad - 380015, Gujarat, India
City Postal code Country Position/Affiliation
Ahmedabad 380015 India CEO
Role Name Email Phone Street address
Public Enquiries Telufusi Adebukunola ATELUFUSI@xceneresearch.com +2348090723870 90b Opebi Road,Ikeja, Lagos, Nigeria Wonderwheels
City Postal code Country Position/Affiliation
Lagos 100281 Nigeria Executive Director
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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