| CTRI Number |
CTRI/2018/12/016574 [Registered on: 10/12/2018] Trial Registered Prospectively |
| Last Modified On: |
24/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the sexual pleasure, performance, acceptability and safety of graphene incorporated natural rubber latex condoms and natural rubber latex condoms. |
Scientific Title of Study
Modification(s)
|
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. |
| Trial Acronym |
- |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ECTS/17/001, Version 02, Date: 29 SEP 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milan Satia |
| Designation |
Chief Executive Officer |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
4th Floor, Office No. 410 to 412, Block No. "G", Titanium City Center, Nr. Sachin Tower, 100 Ft. Road, Satellite.
-
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
- |
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milan Satia |
| Designation |
Chief Executive Officer |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
4th Floor, Office No. 410 to 412, Block No. "G", Titanium City Center, Nr. Sachin Tower, 100 Ft. Road, Satellite.
-
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
- |
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milan Satia |
| Designation |
Chief Executive Officer |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
4th Floor, Office No. 410 to 412, Block No. "G", Titanium City Center, Nr. Sachin Tower, 100 Ft. Road, Satellite.
-
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825585119 |
| Fax |
- |
| Email |
milansatia@ethicare-cro.com |
|
|
Source of Monetary or Material Support
|
| HLL Lifecare Limited, (A Government of India Enterprises) Corporate R & D Centre, Akkulum,
Sreekariyam, P.O Thiruvananthapuram-695017, Kerala, India |
|
|
Primary Sponsor
|
| Name |
HLL Lifecare Limited |
| Address |
Corporate R & D Centre, Akkulum, Sreekariyam-P.O.
Trivandrum-695017, Kerala, India |
| Type of Sponsor |
Other [A Government of India Enterprises] |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India
Nigeria
South Africa |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahil Farid |
Charak Hospital and Research Centre |
Ground Floor OPD, Hardoi Road, Dubbaga, Lucknow, Uttar Pradesh – 226003
Lucknow
UTTAR PRADESH |
8127899707
rahilfarid@yahoo.com |
| Dr Manpreet Kaur |
Deep Hospital |
Ground floor, Department of Gynaecology, 481 Model Town,
Ludhiana – 141002, Punjab, India
Ludhiana
PUNJAB |
9814304593
drmanpreetkaur1960@gmail.com |
| Dr Akash Khobragade |
Grant Medical College and Sir Jamshedjee Jeejeebhoy Group of Hospitals |
Department of Medical & Clinical Pharmacology,
J J Marg, Nagpada-Mumbai Central, Off Jijabhoy Road, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA |
9702658822
akash.khobragade@gmail.com |
| Dr Dnyanesh Morkar |
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre |
OPD no. 11, Civil Hospital Road, Nehru Nagar, Belgaum, Karnataka 590010
Belgaum
KARNATAKA |
09448231298
drdnyaneshmorkar@rediffmail.com |
| Dr Dinesh Agarwal |
Marwari Hospital & Research Centre, |
Department of Medicine, 1st floor,
Sati Jaimati Road, Athgaon, Guwahati, Assam 781008.
Kamrup
ASSAM |
9864061456
Drdinesh944@gmail.com |
| Dr Shalini Srivastava |
Om Surgical Centre and Maternity Home |
SA-17/3,P-4, Sri krishna Nagar, Paharia, Varanasi, UP 221007
Varanasi
UTTAR PRADESH |
9125679989
drshalinivns@gmail.com |
| Dr Sushma R Shah |
V.S. General Hospital |
Gynaecology department, 1st floor, Smt. NHL, Municipal Medical College, Ellisbridge, Ahmedabad – 380006, Gujarat, India
Ahmadabad
GUJARAT |
09824017877
arihantortho@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee Marwari Hospital & Research Centre |
Approved |
| Institutional Ethics committee Charak Hospital and Research Centre |
Approved |
| Institutional Ethics Committee Deep Hospital |
Approved |
| Institutional Ethics committee Om Surgical Center and Maternity Home |
Approved |
| Institutional Ethics Committee Smt. NHL Municipal Medical College |
Approved |
| Institutional Ethics committee, KLE University |
Approved |
| Institutionl Ethics Committee Grant Government Medical College & Sir J.J. Group of Hospitals |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Graphene incorporated natural rubber latex condoms. |
Few layers of graphene incorporated in the natural rubber latex condom |
| Comparator Agent |
Natural rubber latex condoms |
Normal natural rudder latex condom |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
6 Months |
|
|
Target Sample Size
|
Total Sample Size="304"
Sample Size from India="152"
Final Enrollment numbers achieved (Total)= "305"
Final Enrollment numbers achieved (India)="156" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
29/03/2019 |
| Date of Study Completion (India) |
29/06/2020 |
| Date of First Enrollment (Global) |
27/09/2019 |
| Date of Study Completion (Global) |
19/08/2020 |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |