Cupid Female Condom as the contraception for the prevention of pregnancy.

Not Applicable

• Conditions: Health Condition 1: Z309- Encounter for contraceptive management, unspecified

• Registration Number: CTRI/2022/06/043309
• Lead Sponsor: Cupid Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified