| CTRI Number |
CTRI/2025/07/091883 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
PMCF study |
| Study Design |
Other |
|
Public Title of Study
|
PMCF study to evaluate the safety and performance of the Natural Latex Female Contraceptive Condom. |
|
Scientific Title of Study
|
A prospective, observational, multi-centric, non-randomized PMCF study to evaluate the safety and performance of the Natural Latex Female Contraceptive Condom. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roopa Kuchana |
| Designation |
DNB Obstetrician, Gynecologist |
| Affiliation |
Dr. Roopas women health and fertility center |
| Address |
Floor No.1,left side cabin- Gynecologist & Obstetrician
Dr. Roopas women health and fertility center
1st Floor, SMLR Complex, Mallampet Bus Stop, Mallampet. Hyderabad
Hyderabad
TELANGANA
502303
India |
| Phone |
917981970625 |
| Fax |
|
| Email |
drroopasmfc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Kuchana |
| Designation |
DNB Obstetrician, Gynecologist |
| Affiliation |
Dr. Roopas women health and fertility center |
| Address |
Floor No.1,left side cabin- Gynecologist & Obstetrician
Dr. Roopas women health and fertility center
1st Floor, SMLR Complex, Mallampet Bus Stop, Mallampet. Hyderabad
Hyderabad
TELANGANA
502303
India |
| Phone |
917981970625 |
| Fax |
|
| Email |
drroopasmfc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopa Kuchana |
| Designation |
DNB Obstetrician, Gynecologist |
| Affiliation |
Dr. Roopas women health and fertility center |
| Address |
Floor No.1,left side cabin- Gynecologist and Obstetrician
Dr. Roopas women health and fertility center
1st Floor, SMLR Complex, Mallampet Bus Stop, Mallampet. Hyderabad
Hyderabad
TELANGANA
502303
India |
| Phone |
917981970625 |
| Fax |
|
| Email |
drroopasmfc@gmail.com |
|
|
Source of Monetary or Material Support
|
| HLL Lifecare limited,
Plot No.16-A/1, Cochin Special Economic Zone,
Kakkanad, Cochin-682 037, Kerala, India. |
|
|
Primary Sponsor
|
| Name |
HLL Lifecare limited |
| Address |
Plot No.16-A/1, Cochin Special Economic Zone,Kakkanad, Cochin-682 037, Kerala, India. |
| Type of Sponsor |
Other [Medical device manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Roopa Kuchana |
Dr. Roopas women health and fertility center |
1st Floor, SMLR Complex, Mallampet Bus Stop, Mallampet. Hyderabad
Hyderabad
TELANGANA |
07981970625
drroopasmfc@gmail.com |
| Dr Lakshmi Prasanna |
Lotus Hospitals for women & Children Kukatpally |
15, JNTU – Hitech City Road, BHEL HIG Phase 2
Kukatpally Housing Board Colony, Kukatpally,
Hyderabad, Telengana
Hyderabad
TELANGANA |
9949132433
Lakshmiyadavalli2008@gmail.com |
| Dr Lakshmi Prasanna |
Sri Clinic Multi-speciality Clinic |
KPHB, Hyderabad
Lig-233-234, near Basket Ball ground, 7th Phase, Landmark: Basket Ball Court, Hyderabad
Hyderabad
TELANGANA |
9949132433
Lakshmiyadavalli2008@gmail.com |
| Dr Ramya K S |
Sunshine Healthcare Clinic |
Akshaya nagar, Bangalore
89, 14/2 & 14/3, 1 st Floor, Landmark: Above HDFC Bank., Bangalore
Bangalore
KARNATAKA |
8105839826
drramyarao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| S2J INDEPENDENTETHICS COMMITTEE (S2J IEC) |
Approved |
| S2J INDEPENDENTETHICS COMMITTEE (S2J IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnancy Prevention and STI Prevention |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Natural Latex Female Contraceptive
Condom |
Natural Latex Female Contraceptive Condom is a soft pliable rubber latex sheath, which lines the vagina. For Female Condom Type A has an inner ring which is used for insertion, and which holds the sheath in place, and an outer bead, which lies flat against the labia during the intercourse. It is designed for single use only. The sheath is pre-lubricated with a silicone-based lubricant. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
-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.
|
|
| ExclusionCriteria |
| Details |
-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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
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 Outcome
|
| Outcome |
TimePoints |
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. |
required sample size is 363. Each couple will use four condoms over one month.
The following month,they will come for a follow-up. |
|
|
Target Sample Size
|
Total Sample Size="363"
Sample Size from India="363"
Final Enrollment numbers achieved (Total)= "363"
Final Enrollment numbers achieved (India)="363" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objectives: Primary Objectives: The primary objective is 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. Secondary Objectives: 1.To observe any discomfort experienced by user/ partner 2.To monitor the presence of side effects/adverse events 3.Identifying and analyzing emerging risks 4.To observe clinical benefits and ensure continued acceptability of benefit- risk ratio 5.To identify contraindicated scenarios and possible systematic misuse or off-label use of the device 6.User acceptability – product experience and user satisfaction levels.
Study Population:Required sample size is 363 couple. Each couple will use 4 condoms within a period of one month. In total 1452 use cases will be considered for the final analysis.
Study type The study will be a prospective, observational, multi-centric, non-randomized, post-market clinical study.
Study design and data collection method -The subjects who met the inclusion/exclusion criteria and voluntarily agree to participate will be enrolled for the study. -The purpose and requirements of the study will be explained to the prospective couples and informed consent will be obtained from both the participant and their partner. -The safety and performance of the product will be assessed using the PMCF checklist to ensure its effective use. -During the study, more detailed information about sexual activity will be gathered than typically collected during family planning visits. -Each couple will use four condoms and after each use, a coital log has to be filled which is part of the PMCF checklist to document performance and safety of Natural Latex Female Contraceptive Condom. After using all four condoms, each couple will fill out an acceptability and satisfaction questionnaire, also part of the PMCF checklist, and submit the completed PMCF checklist to the study team. -Side effects, risks, contraindications or misuse/ off-label use of the product (if any) will be reported in the PMCF checklist. -In the event of an adverse event (AE) or serious adverse event (SAE) following the use of the product, subjects will be requested to report the event to the doctor immediately. The doctor will assess and report the event as an SAE/AE/ADE, completing the appropriate adverse event/adverse device effect report form. This will then be reported to the sponsor and notified body, if necessary.
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