CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 400 enrolled
Drug / intervention
FC2 Condom +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04233632
NCT04233632N/ACompleted
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Randomized Comparative Study of the Contraceptive Efficacy of the Cupid, Cupid 2 and FC2 Female Condom

Prof Mags Beksinska·interventional·Posted Jan 18, 2020·Updated Jan 19, 2022

In Brief

A clinical study evaluating FC2 Condom, Cupid Condom, and 1 other intervention for Pregnancy Prevention. Completed, enrolled 400 participants across 1 site.

Detailed Summary

This research study aims to assess the effectiveness of three female condoms \[Cupid, Cupid 2 and Female Condom 2(FC2)\] for the prevention of pregnancy among women choosing the female condom (FC) as their method of fertility regulation. Participants will be followed-up monthly for up to seven months. A daily diary will be used to record menstrual pattern, acts of intercourse and details of condom usage.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy Prevention
CountriesSouth Africa
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 18, 2020
Enrollment StartNov 27, 2019
Primary CompletionNov 10, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.5 years ago

Interventions

FC2 Condomdevice

FC2: FC2 is composed of a synthetic nitrile rubber latex and 170mm in length. It has a flexible inner ring as the internal retention mechanism and a circular ring as the outer retention mechanism at the open end of the condom. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and is available in clear and other colors/scents. It is manufactured by Female Health Company, USA and has USFDA, World Health Organisation (WHO)/United Nations Populations Fund (UNFPA) and South African Bureau of Standards (SABS) approval

Cupid Condomdevice

Cupid is composed of a Natural rubber latex and is 155mm in length. It has a Medical grade sponge as the internal retention mechanism and an octagonal outer frame as the outer retention mechanism. It is pre-lubricated with silicone oil. It has a shelf-life of 3 years and is available in clear and red color, vanilla scented variety. It is manufactured by Cupid Ltd, India and has WHO)/UNFPA, India Drug Control Authority, Conformitè Europëenne (CE) Mark of the European Union (EU) and SABS approval

Cupid 2 Condomdevice

Cupid2 is composed of a Natural rubber latex and is 125mm in length. It has a Medical grade sponge as the internal retention mechanism and an octagonal outer frame as the outer retention mechanism. It is pre-lubricated with silicone oil. It has a shelf-life of 3 years and is available in Clear and purple color, vanilla scented variety. It is manufactured by Cupid Ltd, India and has WHO)/UNFPA, India Drug Control Authority, CE Mark of the EU and SABS approval