Comparative Study of the Contraceptive Efficacy of the Cupid, Cupid 2 and FC2 Female Condom

NCT04233632 | Completed

• 1 other identifier: CoCo
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Prevention

Keywords

Female condom; Pregnancy Prevention; Sexually transmitted infection prevention; Condom acceptability; FC2; Cupid

Outcome Measures

Primary Outcomes (1)

• Pregnancy

  The main outcome measure of the study is the occurrence of pregnancy, which will be used to estimate the overall effectiveness of the method. For the overall pregnancy rate all pregnancies will be counted regardless of the reason(s) for the failure. Pregnancy rates will be computed using life table techniques. If the pregnancy rates are reasonably constant with time, then the Pearl index (pregnancies per 100 years of use) will be used and confidence intervals estimated from the Poisson distribution. Discrete time life-table methods will be used to explore patterns of failures associated with correct, incorrect and non-use of condoms (in each interval subjects will be classified according to the type or pattern of condom use and the life-table or Pearl rates computed for each stratum). Failure modes associated with the use of the female condoms per act of intercourse in which a FC was used.

  6-7 months

Secondary Outcomes (8)

• Clinical breakage

  6-7 months

• Non-clinical breakage

  6-7 months

• Total breakage

  6-7 months

• Slippage

  6-7 months

• Misdirection

  6-7 months

Study Arms (3)

FC2 Condom

ACTIVE COMPARATOR

Participants will be randomized to either of the 3 groups and provided with their randomized method at enrolment and at each follow up visit until the final visit.

Device: FC2 Condom

Cupid Condom

ACTIVE COMPARATOR

Participants will be randomized to either of the 3 groups and provided with their randomized method at enrolment and at each follow up visit until the final visit

Device: Cupid Condom

Cupid 2 Condom

ACTIVE COMPARATOR

Participants will be randomized to either of the 3 groups and provided with their randomized method at enrolment and at each follow up visit until the final visit

Device: Cupid 2 Condom

Interventions

FC2 Condom DEVICE

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

FC2 Condom

Cupid Condom DEVICE

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 Condom

Cupid 2 Condom DEVICE

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

Cupid 2 Condom

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Participants must be female as female condoms inserted vaginally are being evaluated
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy sexually active women who have ever used an FC and using condoms (male or female) as their current method of contraception.
• Be 18 to 40 years at enrolment (inclusive).
• Have a negative urine pregnancy test at enrolment visit.
• Is HIV negative
• Have a history of regular cyclic menses (usual length of 21 to 35 days) when not using hormonal contraception.
• Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that ended at 14 or more weeks gestation.
• Have at least one cycle (two menses) after an abortion at less than 14 weeks gestation.
• Be willing to accept a risk of pregnancy.
• Reporting to have at least four acts of heterosexual vaginal intercourse per month for a period of 6 months.
• Be willing to only use the study product (Cupid or FC2 female condom) as the primary method of contraception over the course of the study.
• Be capable of using the study product properly and agree to observe all study directions and requirements.
• Be willing to keep a daily diary to record menstrual pattern, acts of intercourse, and details of condom use and any condom failures.
• Be willing to state that, to her best knowledge, her sexual partner:
• Has not had a vasectomy or been previously diagnosed as infertile.
• Is HIV negative

You may not qualify if:

• Have a history of allergy or sensitivity to rubber latex or water-based /silicone lubricants
• Have evidence of sexually transmitted infections on syndromic assessment and / or vaginal examination
• Be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study.
• Have a history of infertility or pelvic inflammatory disease without a subsequent spontaneous intrauterine pregnancy.
• Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent intrauterine pregnancy.
• Be in a monogamous relationship of less than 4 months with their partner.
• Have any contraindications to pregnancy (medical condition) or regularly use medications that are unsafe to use in pregnancy
• Have shared injection drug needles in the past unless has a negative HIV test at least 6 weeks since last use.
• HIV positive.
• Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within 3 months prior to screening or have clinical evidence of HSV on exam.
• Be lactating or breastfeeding.
• Have any clinically significant abnormal vaginal bleeding or spotting within the month prior to screening.
• Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to screening.
• Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to screening or enrollment.
• Have received a Depo-Provera® injection in the 6 months prior to enrolment or Nur-Isterate in the last 4 months prior to enrolment

Sponsors & Collaborators

• Prof Mags Beksinska: lead

Study Sites (1)

MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit]

Durban, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (20)

• Warren M. Condoms: the multipurpose prevention technologies that already exist. BJOG. 2014 Oct;121(Suppl 5):9-11. doi: 10.1111/1471-0528.12913. No abstract available.

  PMID: 25335833 BACKGROUND

• Peters A, Jansen W, van Driel F. The female condom: the international denial of a strong potential. Reprod Health Matters. 2010 May;18(35):119-28. doi: 10.1016/S0968-8080(10)35499-1.

  PMID: 20541090 BACKGROUND

• Reproductive Health Supplies Coalition. Caucus on new and underused reproductive health technologies. Product brief: female condom. Reproductive Health Supplies Coalition; 2013. [Online]. [Cited: 19th Dec 2016]. URL: https://www.rhsupplies.org/fileadmin/uploads/rhsc/Working_Groups/New_Underused_RH_Technologies_Caucus/Documents/Technical_Briefs/rhsc-brief-female-condom_A4.pdf

  BACKGROUND

• United Nations Population Fund. HIV prevention gains momentum. New York: UNFPA, 2011. 978-0-89714-933-4.

  BACKGROUND

• Center for Health and Gender Equity. Female condoms and US foreign assistance: an unfinished imperative for women's health. Washington, DC; 2011. https://www.unfpaprocurement.org/documents/10157/37547/UNFPA+Female+Cond om+Prequalification+List/05feba45-4893-474a-81d4-7b61e4f68ae7

  BACKGROUND

• Beksinska M, Smit J, Joanis C, Potter W. New female condoms in the pipeline. Reprod Health Matters. 2012 Dec;20(40):188-96. doi: 10.1016/S0968-8080(12)40659-0.

  PMID: 23245425 BACKGROUND

• Mqhayi M,Beksinska M,Smit J,Mqoqi N,Tshukudu D,NutleyT,Hatzell T,Wesson J,Marumo E.Introduction of the female condom in SA: Programmeme activities and performances 1998-2000.Durban: RHRU,FHI,NDoh,2003

  BACKGROUND

• Mantell JE, Scheepers E, Karim QA. Introducing the female condom through the public health sector: experiences from South Africa. AIDS Care. 2000 Oct;12(5):589-601. doi: 10.1080/095401200750003770.

  PMID: 11218545 BACKGROUND

• Farr G, Gabelnick H, Sturgen K, Dorflinger L. Contraceptive efficacy and acceptability of the female condom. Am J Public Health. 1994 Dec;84(12):1960-4. doi: 10.2105/ajph.84.12.1960.

  PMID: 7998637 BACKGROUND

• Bounds W, Guillebaud J, Newman G B. Female Condom (Femidom). A clinical study of its use-effectiveness and patient acceptability. The British Journal of Family Planning 1992; 18:3641.

  BACKGROUND

• Trussel J. Contraceptive efficacy of the Reality female condom. Contraception 1998;58: 148.

  BACKGROUND

• Trussell J, Sturgen K, Strickler J, Dominik R. Comparative contraceptive efficacy of the female condom and other barrier methods. Fam Plann Perspect. 1994 Mar-Apr;26(2):66-72.

  PMID: 8033980 BACKGROUND

• Steiner M, Trussell J, Glover L, Joanis C, Spruyt A, Dorflinger L. Standardized protocols for condom breakage and slippage trials: a proposal. Am J Public Health. 1994 Dec;84(12):1897-900. doi: 10.2105/ajph.84.12.1897.

  PMID: 7998626 BACKGROUND

• Beksinska M, Joanis C, Manning J, Smit J, Callahan M, Deperthes B, Usher-Patel M. Standardized definitions of failure modes for female condoms. Contraception. 2007 Apr;75(4):251-5. doi: 10.1016/j.contraception.2006.10.003. Epub 2007 Feb 7.

  PMID: 17362701 BACKGROUND

• Frezieres RG, Walsh TL, Nelson AL, Clark VA, Coulson AH. Evaluation of the efficacy of a polyurethane condom: results from a randomized, controlled clinical trial. Fam Plann Perspect. 1999 Mar-Apr;31(2):81-7.

  PMID: 10224546 BACKGROUND

• Beksinska M, Nkosi P, Mabude Z, Smit J, Zulu B, Phungula L, Greener R, Kubeka M, Milford C, Lazarus N, Jali Z, Mantell JE. Twenty years of the female condom programmeme in SA: past, present and future. SAn Health Review, 2017. Chapter 14. In: Padarath A, Barron P, editors. SAn Health Review 2017. Durban: Health Systems Trust; 2017. URL: http://www.hst.org.za/publications/south-african-health-review-2017. Pg 147

  BACKGROUND

• Beksinska ME, Piaggio G, Smit JA, Wu J, Zhang Y, Pienaar J, Greener R, Zhou Y, Joanis C. Performance and safety of the second-generation female condom (FC2) versus the Woman's, the VA worn-of-women, and the Cupid female condoms: a randomised controlled non-inferiority crossover trial. Lancet Glob Health. 2013 Sep;1(3):e146-52. doi: 10.1016/S2214-109X(13)70054-8. Epub 2013 Aug 23.

  PMID: 25104263 BACKGROUND

• Joanis C, Beksinska M, Hart C, Tweedy K, Linda J, Smit J. Three new female condoms: which do South-African women prefer? Contraception. 2011 Mar;83(3):248-54. doi: 10.1016/j.contraception.2010.08.002. Epub 2010 Sep 17.

  PMID: 21310287 BACKGROUND

• Beksinska M, Greener R, Kleinschmidt I, Pillay L, Maphumulo V, Smit J. A randomized noninferiority crossover controlled trial of the functional performance and safety of new female condoms: an evaluation of the Velvet, Cupid2, and FC2. Contraception. 2015 Sep;92(3):261-7. doi: 10.1016/j.contraception.2015.05.008. Epub 2015 May 20.

  PMID: 26002805 BACKGROUND

• Farley TM. Life-table methods for contraceptive research. Stat Med. 1986 Sep-Oct;5(5):475-89. doi: 10.1002/sim.4780050512.

  PMID: 3538263 BACKGROUND

Study Officials

• Mags E Beksinska, PhD

  MatCH Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The three condoms in the trial are distinctly different and so condom specific training is required and so cannot be blinded. The statistician analysing the data will be blinded to female condom type.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Executive Director

Model Details: This research study will be a parallel randomized controlled trial to assess the effectiveness of three female condoms (Cupid, Cupid 2 and FC2) for the prevention of pregnancy among women choosing the female condom as their method of fertility regulation

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: November 27, 2019
• Primary Completion: November 10, 2021
• Study Completion: November 10, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)