Frequent use may alter the vaginal flora, possibly leading to an increased risk of urinary tract infection ( Scholes 2000 ). It can also damage the epithelium, possibly facilitating infection with HIV among female sex workers ( WHO 2002 ). The World Health Organization considers spermicides a category 4 method (contraindicated) for women at high risk of HIV infection and those already infected ( WHO 2004 ). The probability of pregnancy with spermicide alone varies widely. Gel may be a more acceptable spermicide formulation than film or vaginal suppository ( Raymond 2004 ). In general use outside of research settings, spermicides fall into the bottom tier of contraceptive effectiveness ( Steiner 2003 ). On the other hand, advantages of spermicides for women at low risk of HIV infection include easy availability, moderate cost, absence of systemic effects, and control by the woman. “Nonoxynol-9 spermicide for prevention of vaginally acquired HIV and other sexually transmitted infections: systematic review and meta-analysis of randomised controlled trials including more than 5000 women”. 33 But a 2002 systemic review and meta-analysis of nine randomized controlled trials of vaginal nonoxynol-9 for HIV and STI prevention involving more than 5,000 women (predominantly sex workers) found no statistically significant reduction in risk of HIV and STIs, but found a small statistically significant increase in genital lesions among nonoxynol-9 spermicide users. Up-to-date pricing and reviews for contraceptive gels on the market can be found at the many weeks pregnant website.
Trials had to focus on a spermicide used alone for birth control The product could be compared to a different spermicide, the same spermicide used with a barrier method, another dose of the same spermicide, a different base for the same product, or another type of birth control Each study must have had data on pregnancy. Spermicides and vaginal sponges are two over-the-counter birth control methods used during sex to prevent pregnancy. Some women report that the lubrication provided by spermicide improved intercourse for them ( Vandebosch 2004 ). Although protection against some sexually‐transmitted infections had been reported in the past, primarily with in vitro studies, more recent clinical trials have not confirmed this benefit ( Cates 2007 ; Roddy 1998 ; Roddy 2002 ; Van Damme 2002 ). Spermicides with nonoxynol‐9 are not effective as microbicides, and may increase susceptibility to HIV if used more than twice a day ( Cates 2007 ).
BufferGel® was safe and well tolerated in women 8 – 10 and reduced the prevalence of bacterial vaginosis (BV) when applied twice daily for 2 weeks 9 However, it did not alter the risk of HIV infection in a large-scale effectiveness trial 10 When combined with a diaphragm, BufferGel® was as effective as N-9 for contraception; the 6-month pregnancy rate per hundred women was 10.1% (95% confidence interval CI 7.1-13.1%) for BufferGel® and 12.3 (95% CI 7.7-16.9) for N-9 spermicide users 11 However, no reduction in pregnancy rate was observed when BufferGel® was used alone and dosed pericoitally 10. As with female contraceptive trials with self-administration methods, nonadherence with daily gel application in some subjects may contribute to the lower spermatogenesis suppression rate as well as sperm rebound after suppression observed in this study. We included all randomized controlled trials in any language that compared any spermicide used alone for contraception with another method; pregnancy must have been reported as an outcome.
Several epidemiological studies indicate that systemic hormonal contraception, particularly progesterone-containing injectables, may be associated with an increased risk of both HIV acquisition and transmission 1 – 3 Moreover, nonoxynol-9 (N-9), approved in the United States as a vaginal contraceptive, provides no protection against HIV or other sexually transmitted infections 4 , 5 and frequent use was shown to be associated with an increased risk of HIV acquisition 6 Thus, the development of safe and effective alternative contraceptives is a major global health priority. Couples are being recruited to take part in a groundbreaking trial of a male contraceptive gel that could allow men and women to take equal responsibility for birth control in future. Spermicides and vaginal sponges do not work as well at preventing pregnancy as some other forms of birth control.
Raymond EG, et al. Contraceptive effectiveness and safety of five nonoxynol-9 spermicides: a randomized trial. About 500,000 American women are thought to use vaginal spermicidal products containing nonoxynol-9 for contraception, but data on the effectiveness of these agents are limited. This is because the success of male contraception depends on near complete suppression of sperm production while maintaining healthy testosterone levels to maintain a man’s sexual drive (libido).
Despite this, the discontinuation rates for women participating in self-administration contraceptive methods such as spermicide averaged 44%, vaginal rings 32%; and female condom 49% at 6 months (personal communication with D. L. Blithe, Ph.D., NIH NICHD). A recent 2-yr study using monthly T undecanoate injections in more than 1000 healthy Chinese men showed efficacy rates similar to female hormonal contraceptives ( 5 ). However, monthly injections are inconvenient and contraceptive regimens using T alone are not as effective in non-Asian men ( 8 , 10 , 11 ). Addition of progestins to exogenous T enhances the rate and extent of suppression of spermatogenesis in men of all races with few short-term side effects ( 11 – 24 ). Male hormonal contraceptive strategies to date have relied on combining injections, patches, or pellets of T (or its esters) with injectable, oral, or implants of progestins in two delivery forms. We searched computerized databases for randomized controlled trials of spermicides for contraception: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, POPLINE, LILACS, and EMBASE.
The pregnancy probabilities varied widely in reported trials, but have been as high as 28% over six months of use ( Raymond 1999 ). Few important differences emerged between products, although a gel containing nonoxynol‐9 52.5 mg was inferior to two other products tested in one trial ( Raymond 2004 ). Aside from this one product, personal characteristics and behavior of users may be more important than characteristics of the spermicide products themselves in determining the likelihood of pregnancy. We did computer searches for randomized trials of spermicides used for birth control. We searched the following computerized databases for randomized controlled trials of spermicides for contraception: CENTRAL, MEDLINE, POPLINE, LILACS, EMBASE, , and ICTRP.
The World Health Organization recently ended a trial of a male-birth-control injection early , after participants complained about acne and mood swings (both of which are common side effects for women who take the pill). The male gel keeps other tissues in the body functioning at normal testosterone loads, so it won’t chemically castrate the men , which has been a concern in the past with some male-birth-control-pill trials. The road to market for Amphora, the Evofem gel, shows how long and winding it can be for contraceptives. About 20 years ago, Rush University’s labs in Chicago developed a version of the gel at a time of surging interest in products that could tackle both birth control and sexually transmitted diseases such as HIV.
In August 2013, we searched the following computerized databases for randomized controlled trials of spermicides for contraception: CENTRAL, MEDLINE , POPLINE, LILACS, EMBASE , , and ICTRP. A gel containing nonoxynol-9 52.5 mg was inferior to two other products tested in the largest trial Aside from this finding, personal characteristics and behavior of users may be more important than characteristics of the spermicide products in determining the probability of pregnancy. In August 2013, we did computer searches for randomized trials of spermicides used for birth control We have not found any new trials since the initial review For the initial review , we also wrote to researchers to find other trials.
Most contraceptive vaginal gels are surfactant-based spermicides that contain the active ingredient nonoxynol-9, which kills sperm by destroying the cell membrane. The women in the trial will also use a form of female birth control for about the first four months their male partners are using the contraceptive gel. More than a decade in the making, the male birth control that’s furthest along in clinical trials is a gel called Nestorone-Testosterone.
Spermicides are not as effective as many other birth control methods , such as birth control pills or intrauterine devices (IUDs). • N-9 contraceptive products designed exclusively for vaginal use remain an important option for pregnancy prevention for women who have sex infrequently and are at low risk of HIV infection; removing these products from the market is unwarranted. Contraceptive effectiveness and safety of five nonoxynol-9 spermicides: A randomized trial.
Vaginal douching is not considered a birth control method even if it is done with spermicides. This means that in 1 year, 28 out of 100 women who use spermicide as their only method of birth control get pregnant. Using spermicide alone is not recommended because it offers poor pregnancy prevention and does not protect against sexually transmitted infections (STIs) In fact, the nonoxynol-9 in most spermicides may increase the risk of getting HIV/AIDS from an infected partner.
In August 2013, we searched the following computerized databases for randomized controlled trials of spermicides for contraception: CENTRAL, MEDLINE, POPLINE, LILACS, EMBASE, , and ICTRP. When Lisa Rentz decided she’d had enough of birth control pills, she walked into her local drug store and picked up something different: a vaginal contraceptive film that contains the spermicide nonoxynol-9, or N-9. Study participants were asked to engage in at least 4 acts of vaginal sexual intercourse per month, use the study product as the primary method of contraception, and keep a diary of coital activity, product use, use of other vaginal products, and adverse events.
We conducted a multicenter, randomized, double-masked, controlled trial to assess whether a gel containing the spermicide C31G was non-inferior to a commercially available product containing nonoxynol-9. A safe, highly effective and reversible method of male contraception would fill an important public health need,” study investigator Diana Blithe, PhD, chief of NICHD’s Contraceptive Development Program, said in a news release. “Expanding male contraceptive options could help make familyplanning more of a shared responsibility between women and men,”says Regine Sitruk-Ware, co-director of the trial, explaining theurgent need to develop an effective male contraceptive treatment.”Safe, effective, and reversible tools for men to control their ownfertility gives new meaning and significance to the term ‘familyplanning.’ No matter the challenge, we must continue to innovateand develop new products to improve lives.”
Contraceptive gels are a form of chemical contraception which act as a birth control method. Using spermicides along with other methods, such as male or female condoms or the diaphragm, will reduce the chance of pregnancy even more. If spermicides are not used correctly, the risk of pregnancy is more than 25 for every 100 women each year.
The success of a reversible contraceptive for men requires an approach that reduces the production of sperm without impacting a man’s testosterone levels or ability to produce sperm at a later date,” said Christina Wang, Los Angeles Biomedical Research Institute lead researcher and a study principal investigator. More than 400 couples are anticipated to enroll in the Phase IIb trial, which is the first to test the gel product for contraceptive efficacy, or pregnancy prevention, in the female partner. Previous clinical studies conducted with the Clinical Trial Network of the NICHD indicate that the use of the Nestorone®/Testosterone gel reduced sperm production to a level considered to indicate successful sperm suppression while maintaining healthy testosterone levels, and thereby minimizing side effects such as lower libido, acne, weight gain, and altered cholesterol levels.
They are not 100% effective for pregnancy protection and may be used in combination with contraceptive gels and foams which are sold over the counter for women. Health Canada warns that N9 in vaginal contraceptives and spermicides may irritate the lining of the vagina or rectum. In prior, less burdensome contraceptive clinical trials conducted at our two centers in which suppression of spermatogenesis is the end point, the discontinuation rate ranged from 10 to 25% ( 19 , 23 , 36 , 38 ). In contraceptive clinical trials in women, subjects are motivated to participate due to a small reimbursement and a desire to avoid pregnancy.
This is the first study of a transdermal male hormonal contraceptive regimen showing effective suppression of spermatogenesis using T gel combined with the nonandrogenic progestin NES gel. A pilot study using T and NES transdermal gels in healthy men for 20 d showed effective gonadotropin suppression without any significant adverse events ( 26 ), prompting us to evaluate this gel-gel combination for potential use as a male hormonal contraceptive. Progestins used in prior male contraceptive clinical trials, including 19-nortestosterone derivatives (levonorgestrel, etonogestrel, and norethisterone enanthate) or pregnane-derived medroxyprogesterone acetate, show significant androgenic activity in vitro and in vivo ( 25 ). Nestorone (NES; 16-methylen-17α-acetoxy-19-norpregn-4-ene-3, 20-dione) is the first 19-norprogesterone-derived progestin to be used for male contraception.
At enrollment, potential participants received posttest counseling, were tested for pregnancy with a urine test, were informed further about the nonoxynol-9 gel study, gave a second consent, provided an oral mucosal transudate specimen (OraSure, Epitope Inc, Beaverton, Ore) for HIV testing (Wellcozyme HIV 1 and 2 GACELISA gamma antibody capture enzyme-linked immunosorbent assay, Murex, Oxford, England), and gave a urine specimen for testing for N gonorrhoeae and C trachomatis by ligase chain reaction. The participants could not have a history of an adverse reaction to products containing latex or nonoxynol-9, be using a spermicide, be pregnant, or have a seropositive HIV test result. Five randomized placebo-controlled trials of nonoxynol-9 for STI prevention have compared 4 products: 2 gels, 9 , 10 a sponge, 11 and a film.
Four trials performed a blinded comparison of vaginal foaming tablets with either nonoxynol‐9 100 mg or menfegol 60 mg as the active agent ( Chompootaweep 1990 ; Ghunney 1987 ; Klufio 1988 ; Ruoff 1988 ). Pregnancy rates among users of the two products were comparable over 6 and 12 months of use. (((spermicides OR spermatocidal agents) AND contracept) AND (clinical trials OR comparative trials)) NOT (stds/aids/hiv infection). Trials using spermicides for prevention of sexually‐transmitted infections were excluded.
Although vaginal spermicides have been used as contraceptives for millennia, only recently have these methods received scientific scrutiny. Because of the limited appeal and effectiveness of spermicides, recruitment to recent trials has been difficult. Randomized controlled trials of spermicides pose daunting challenges for investigators.
The product could be compared to a different spermicide, the same spermicide used with a barrier method, another dose of the same spermicide, a different base for the same product, or another type of birth control. Trials had to focus on a spermicide used alone for birth control. Currently available spermicides containing nonoxynol-9 are ineffective as microbicides, in particular as HIV-preventive measures.17 Thus, spermicides used alone are not recommended to prevent HIV or other STIs. Be sure to visit many weeks pregnant for the best contraceptive gels on the market to buy.
Especially after the prohibition of contraception in the U.S. by the 1873 Comstock Act , spermicides—the most popular of which was Lysol —were marketed only as “feminine hygiene” products and were not held to any standard of effectiveness.