Lea's Shield®: A study of the safety and efficacy of a new vaginal barrier contraceptive used with and without spermicide

Mauck, Christine; Glover, Lucinda; Miller, Eric A.; Allen, Susan; Archer, David F.; Blumenthal, Paul D.; Rosenzweig, Bruce A.; Dominik, Rosalie; Sturgen, K; Cooper, Jay S.; Fingerhut, Fred; Peacock, Lisa M.; Gabelnick, Henry L.

doi:10.1016/0010-7824(96)00081-9

Cited by 44 publications

(22 citation statements)

References 3 publications

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“…Instead, we designed a sheep study that parallels the human post-coital test (PCT) [34][35][36][37][38] , which assesses the reduction of PM sperm in the FRT given that PM sperm is required for fertilization. Clinical PCT studies have proven to be highly predictive of contraceptive efficacy in contraceptive effectiveness clinical trials [38][39][40][41][42][43] . The sheep vagina is physiologically and anatomically very similar to the human vagina 44,45 , making it the gold standard for assessing vaginal products.…”

Section: Fif and Ffiff Effectively Reduce Pm Sperm In Sheep Vaginamentioning

confidence: 99%

Engineering highly multivalent sperm-binding IgG antibodies for potent non-hormonal female contraception

Shrestha

Schaefer

Saada

et al. 2020

Preprint

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Many women risk unintended pregnancy due to dissatisfaction with available hormonal contraceptive methods. This led us to pursue topical sperm-binding monoclonal antibodies as a strategy for safe, non-hormonal contraception. Motivated by the greater agglutination potencies of polymeric immunoglobulins such as IgM and the exceptional bioprocessing ease in manufacturing IgG, we engineered IgGs possessing 6-10 Fabs against a unique surface antigen universally present on human sperm. These highly multivalent IgGs (HM-IgGs) are at least 10-to 16-fold more potent and faster than the parent IgG at agglutinating sperm, while preserving Fc-mediated trapping of individual spermatozoa in mucus. The increased potencies translate to effective (>99.9%) reduction of progressively motile sperm in the sheep vagina using 33 micrograms of the 10 Fab HM-IgG. HM-IgGs produce at comparable yields and possess identical thermal stability to the parent IgG, with greater homogeneity. HM-IgGs represent not only promising biologics for non-hormonal contraception but also a promising platform for generating potent agglutinating mAb for diverse medical applications.

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Section: Fif and Ffiff Effectively Reduce Pm Sperm In Sheep Vaginamentioning

confidence: 99%

Engineering highly multivalent sperm-binding IgG antibodies for potent non-hormonal female contraception

Shrestha

Schaefer

Saada

et al. 2020

Preprint

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“…A single study (Mauck et al, 1996) of pregnancy rates in women using Lea’s Shield with and without spermicide demonstrated an overall failure rate of 14%. A total of 84% were multiparous.…”

Section: Lea’s Shieldmentioning

confidence: 99%

New Options for Barrier Contraception

Yranski

Gamache

2008

Journal of Obstetric, Gynecologic & Neonatal Nursing

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“…Data on the efficacy and acceptability of Lea's Shield are limited to results of one 6‐month clinical trial conducted as part of the FDA new device application process 14 . The study compared the efficacy of Lea's Shield with and without spermicide use in 146 volunteers.…”

Section: Common Characteristics Of Cervical Barrier Contraceptive Metmentioning

confidence: 99%

“…The estimated 12‐month failure rate in the spermicide group would be about 15/100 users. This estimated rate assumes that in the second 6 months, the failure rate is 75% of the calculated 6‐month rate 14 . Eight‐four percent of subjects were parous; all pregnancies occurred in parous women.…”

Section: Common Characteristics Of Cervical Barrier Contraceptive Metmentioning

confidence: 99%

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Women's Barrier Contraceptive Methods: Poised for Change

Narrigan

2006

J Midwife Womens Health

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Over the past 20 years, the number of women in the United States choosing a cervical barrier contraceptive method has dramatically declined. By 2002, fewer than 3% of women reported using any woman-initiated barrier method, including the diaphragm, female condom, or cervical cap. At the same time, however, research in infectious diseases indicates that cervical barriers may effectively prevent the transmission of several sexually transmitted infection. This possibility has fueled the recent development of two novel devices. This article examines the seven devices currently available in the United States, comparing their characteristics, efficacy, benefits, and drawbacks. Compared to the diaphragm, the new devices do not offer improved odds of pregnancy prevention, and evidence for their efficacy is sparse. Reasons for the limited acceptance of these methods as contraceptives on one hand-and for interest in their potential for limiting sexually transmitted infections on the other-will also be reviewed. Despite the limited acceptance of cervical barrier methods, midwives and other clinicians should promote their availability as an alternative to other reversible contraceptives.

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Lea's Shield®: A study of the safety and efficacy of a new vaginal barrier contraceptive used with and without spermicide

Cited by 44 publications

References 3 publications

Engineering highly multivalent sperm-binding IgG antibodies for potent non-hormonal female contraception

Engineering highly multivalent sperm-binding IgG antibodies for potent non-hormonal female contraception

New Options for Barrier Contraception

Women's Barrier Contraceptive Methods: Poised for Change

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