Contraceptive Products Research Articles

Documented short-term continuation rates for combined hormonal contraceptives in an indigent population with ready access to contraceptive supplies

One problem women have successfully using combined hormonal contraception is the limited supplies they are dispensed. Patients at the Women's Health Care Clinic at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center have virtually no barriers to method switching, so it is possible to estimate the impacts that more generous prescribing policies have on short-term continuation rates. Anonymous chart review of all women who initiated hormonal contraception between Jan. 1 and June 30, 2005. Only 40.4% of women had documented use for at least 3 months. Women dispensed supplies for 3 or more cycles at the initial visit were more likely to continue use for 3 months (47.8%) than were women dispensed fewer cycles (31.9%) (P < .0001). More liberal dispensing policies may increase the wastage of combined hormonal contraceptive product, but they significantly increase at least intermediate term use of those methods.

10th Summit Meeting consensus: recommendations for regulatory approval for hormonal male contraception

The investigators at the 6th Summit Meeting on Hormonal Male Contraception Petersberg Germany held on July 7-9 2002 recognized the need for standardized clinical trials to develop a hormonal male method and drafted several recommendations. At the 9th Summit Meeting on Hormonal Contraception Nyon Switzerland held on October 9-11 2005 the group of experts reviewed the status of clinical development projects for male hormonal contraception and discussed the need to update the recommendations. The following revised recommendations are the result of this discussion and present the consensus statement confirmed at the 10th Summit Meeting New York October 22-23 2006: It is stressed that the following recommendations are valid exclusively for hormonal methods for which the mechanism of action is based on the inhibition of sperm production. Methods with a different mode of action are outside the scope of these recommendations. The goal of hormonal male contraception is the reversible suppression of spermatogenesis to a level compatible with infertility. In principle this can be achieved by using an androgen alone or an androgen in combination with a gestagen or a GnRH antagonist. The success of this principle in terms of lowering sperm counts in semen to azoospermia or to severe oligozoospermia has been demonstrated in multiple studies. Some trials demonstrated the contraceptive efficacy of this approach when couples used no other method of contraception. Investigators agree that information gained from preliminary studies on male contraception have reached a stage that hormonal contraceptive products for men should now be proposed for development for general use. (excerpt)

The cost of unintended pregnancy in the United States

Introduction Despite the many contraceptive options available in the United States, nearly half (49%) of the 6.4 million pregnancies each year are unintended; these represent a significant cost to the health care system. Methods The total number of unintended pregnancies and their outcomes were obtained from the literature. Direct medical costs were estimated for each unintended pregnancy outcome. Results The direct medical costs of unintended pregnancies were US$5 billion in 2002. Direct medical cost savings due to contraceptive use were US$19 billion. Discussion Unintended pregnancies are a costly problem in the United States. Contraceptive use can reduce direct and indirect costs; hence, payers may realize cost savings by providing coverage of contraceptive products.

Health literacy and contraception: A readability evaluation of contraceptive instructions for condoms, spermicides and emergency contraception in the USA

Objective To assess readability of over-the-counter (OTC) contraceptive product instructions currently available, compare the results with previous studies from a decade ago, and review the implications for health care providers, in particular pharmacists counseling on OTC contraceptives.Methods A sample of contraceptive instructions was submitted to a readability analysis using four standard readability formulas. Products included condoms, spermicides, and emergency contraception instruction pamphlets.Results Reading grade levels for condoms ranged from 6th to 12th grade. The average reading levels for the spermicides were 9th–10th grade and for the emergency contraceptives 10th–12th grade. These results were consistent with those of similar studies performed a decade ago.Conclusions Consumers need to have at least a high school reading level in order to comprehend current product instructions. Very little has changed in the past decade regarding readability of OTC contraceptive patient instructions, despite calls to simplify written instructions. Healthcare providers, in particular pharmacists, must be aware of these disparities to enhance patient education and advocate for simpler reading materials.

Current Issues in Emergency Contraception: An Overview for Providers

Emergency contraception has the potential to greatly reduce the number of unintended pregnancies occurring each year in the United States. Emergency contraception is a safe and effective intervention to which all women should have easy access in the event of an act of unprotected intercourse. Methods of emergency contraception include combined hormone oral contraceptive pills, progestin-only oral contraceptive pills, a dedicated progestin-only emergency contraceptive product, and insertion of a copper intrauterine device. Barriers exist to the increased use of emergency contraception, including the prescription-only status of all of the methods and lack of accurate knowledge on the part of health care providers and consumers. This article provides an overview of the clinical management of emergency contraception.

P-171: Use of parallel searches in the FDA spontaneous report database to assist in safety monitoring of hormonal contraceptives

To characterize the reporting of thromboembolic adverse events across three contraceptive products (ORTHO EVRA, a transdermal patch; NUVARING, an intravaginal ring; and YASMIN, an oral pill with a new progestin) using the Food and Drug Administration’s Adverse Event Reporting System (AERS). Parallel searches of the AERS were used to calculate reporting frequency and proportional reporting rates. Cumulative data from the AERS were analyzed through the end of the first quarter (1Q) of 2005, with the search limited to domestic, United States health care professional reports, excluding application site and/or allergic reactions. Thromboembolic events (cerebrovascular accident, deep vein thrombosis, pulmonary embolism, myocardial infarction, and death) were evaluated. Data were retrieved via WebVDME (version 5.1, Lincoln Technologies, Inc.). For the same time period, IMS data were used to estimate total exposure to each product. The number of adverse events reported, reporting rate and proportional reporting rate were determined. ORTHO EVRA had the greatest number of reports within the AERS database. Thromboembolic events were reported for all three products. The number of thromboembolic events was comparable for both ORTHO EVRA and YASMIN. The reporting rate and proportional reporting rate were in the same order of magnitude across products. These data indicate that thromboembolic adverse event reports are to be expected in populations exposed to combined hormonal contraceptives, regardless of the formulation (transdermal patch, pill, or ring) or route of administration.

Drospirenone

Drospirenone (DRSP) is a compound with mingled identities having been viewed as a diuretic,1 a progestational agent,2 and/or an antimineralocorticoid agent with an ability to reduce blood pressure (BP).3–6 The multiple personalities of this compound can be seen by examining the position adopted by the United States Anti-Doping Agency on its use as a diuretic in athletes. Until January 2005, athletes were prohibited from using the fixed-dose combination contraceptive product (3-mg DRSP/0.03-mg ethinylestradiol [EE]) in or out of competition specifically because it contained the diuretic DRSP, albeit a compound with very weak diuretic properties.1 This restriction on DRSP use in athletes has been lifted, although the use of spironolactone is still outlawed. More recently, DRSP has gained some momentum as an antihypertensive agent.3–6 All along, DRSP has been a progestational agent used in combination with estrogen for birth control or treatment of vasomotor symptoms relating to menopause.2 DRSP, formerly called dihydrospirorenone, is chemically related to 17α- spironolactone. It is a synthetic progestogen, which more closely resembles natural progesterone than conventional synthetic progestogens. As such, it possesses clinically recognizable antimineralocorticoid activity and is estimated to be 8 times more potent than spironolactone (3 mg of DRSP=25 mg of spironolactone).7 DRSP pharmacokinetics are such that it has an oral bioavailability of &80%, a half-life of 30 to 35 hours, and is without active metabolites, a characteristic that distinguishes it from spironolactone.7 In early studies, administration of 2 mg of DRSP daily for 6 days …

Emergency Contraception: In Reply

In Reply.—The American Academy of Pediatrics (AAP) Committee on Adolescence welcomes Dr Gold's letter and the opportunity to correct the dose and product recommendations of readily available emergency contraceptive (EC) products. Although the position paper1 was current at the time it was written and approved by the AAP, she is correct in noting that the availability of products has changed.Drs Stanford and Mikolajczyk identify several additional references that selectively address the lack of evidence for reductions in abortion rates for populations for which EC is available. However, whether populations in Scotland and China are reasonably extrapolated to the United States is not clear; in addition, recent studies suggesting that EC is associated with responsible sexual behavior in Scotland were not reviewed in our article or in the letter.Their reading of the policy also somewhat misses the point. It is appropriate for primary care organizations to judge the available evidence and make recommendations for best clinical practices even when extensive efficacy data are not available. The AAP believes that “[e]mergency contraception has the potential to further decrease the rate of unintended teen pregnancies in the United States.”

“More Than Just Boots! The Eugenic and Commercial Concerns behind A. R. Kaufman’s Birth Controlling Activities”

A. R. Kaufman (1885-1979), founder of the Kitchener-based Kaufman Rubber Company, was nicknamed "Canada's Mr. Birth Control" because he established the Parents' Information Bureau (PIB)-a birth control information centre that functioned out of his factory office. Besides creating mail order/home visiting services, Kaufman also funded birth control clinics. Because he was a rubber manufacturer, it was widely believed that commercial concerns were behind his activities. This article examines recently archived material, local newspaper accounts, and court transcripts to connect A. R. Kaufman and the PIB with the manufacture of contraceptive products. It also outlines Kaufman's involvement with the eugenics movement, especially his dealings with medical practitioners who carried out sterilization procedures for the PIB.

PIII-49Comparison of ethinyl estradiol exposure among approved contraceptive products in the U.S.

PIII-49Comparison of ethinyl estradiol exposure among approved contraceptive products in the U.S.

Wildlife Contraceptives: A Regulatory Hot Potato

Changing cultural values and increasing urbanization in the United States are curtailing traditional wildlife management tools used to effectively manage conflicts between human and wildlife populations. Because of this trend, the USDA Wildlife Services, National Wildlife Research Center (NWRC) began developing wildlife contraceptives in 1991. Since that time, NWRC scientists have steadily worked toward the goal of developing and registering contraceptive products that are practical to use, safe for the treated animal, and present little risk to humans, nontarget animals, and the environment. Working cooperatively with Innolytics, LLC, OvoControl G™ was recently registered for reducing the hatchability of Canada goose eggs. Another product developed by the NWRC, the single-shot GonaCon™ Immunocontraceptive Vaccine is poised to begin the registration process. A third product, DiazaCon™, soon will be tested for field efficacy and should begin the registration process within the year. Between 1996 and the present, the regulatory agency responsible for wildlife contraceptives has been the Food and Drug Administration, Center for Veterinary Medicine (CVM). Working under this premise, the NWRC has progressed toward fulfilling CVM’s regulatory requirements by conducting field efficacy studies and a target animal safety study. NWRC explored various registration options with the CVM, and also with the USDA APHIS Center for Veterinary Biologics (CVB). Through this process, it became clear that wildlife contraceptives were incompatible with CVM’s regulatory process, and outside the regulatory authority of CVB. In response, CVM and the U.S. Environmental Protection Agency (EPA) negotiated an agreement on contraceptive uses. The EPA will assume regulatory authority of contraceptives used for wildlife and feral animals. The CVM will retain authority over all uses in captive animals including livestock, companion animals, and zoo animals.

Do Participant Characteristics Influence the Effectiveness of Behavioral Interventions? Promoting Condom Use to Women

This study assessed whether participant baseline characteristics modified the effects of a skill-based intervention promoting condom use. The randomized, controlled trial enrolled 427 women from a sexually transmitted disease clinic in Birmingham, Alabama. The main outcome measures: consistent (100%) and problem-free (correct, no breakage or slippage) condom use were verified by sexual diary self-report and contraceptive product counts. The enhanced intervention group had a 60% higher consistent condom use rate compared to the basic group (risk ratio [RR], 1.6; 95% confidence interval [CI], 1.4-1.8). There was no statistically significant difference between groups in relationship to problem-free, consistent use (RR, 1.0; 95% CI, 0.9-1.1). A binomial regression analysis identified the following factors as significant modifiers of intervention effectiveness on consistent condom use: intention to use condoms next time, early-age sexual debut, marital status combined with place of intercourse, and substance use before sex. The results suggest that participant baseline characteristics can be modifiers of intervention effectiveness.

Current Contraceptive Research and Development

The approval of various new contraceptive products in recent years has resulted in broadening the options available to women. Trends in contraceptive research for hormonal products include variations in dose and dosing regimens, introduction of novel compounds, evaluation of products for noncontraceptive indications, and development of nonoral delivery systems and male contraceptives. Nonhormonal areas of research include microbicidal products, dual protection methods, and contraceptive vaccines. For each of these categories, contraceptive products currently in development and the potential implications for adolescents are discussed. Ongoing contraceptive research and development activity is robust and should ensure the continued availability of various new products for adolescents.

Progestin Only Contraceptives and Their Use in Adolescents: Clinical Options and Medical Indications

Some adolescents use progestin only contraceptive products because of an underlying medical condition; others simply prefer them. Current options include pills, a long -acting intramuscular injection, an implant, and a progestin-releasing intrauterine device. Also available is Plan B, a progestin only emergency contraceptive option. Although these products vary in efficacy, they are generally safe and well tolerated by adolescents. The implants and intramuscular injections are particularly well suited for adolescent use because of their need for little compliance, well-tolerated adverse effect profile, and excellent efficacy rates.

A Review of the Physical and Chemical Properties of Human Semen and the Formulation of a Semen Simulant

A fluid medium was developed to simulate the salient physical and chemical properties of human semen. The composition of the medium was based upon an extensive review of the literature on constituents of human semen. In choosing the ingredients for this medium, the goal was to emphasize properties that influence interactions of human semen with topical contraceptive, prophylactic, or therapeutic products. Among these properties, pH and buffering capacity, osmolarity, ionic strength, and rheological properties play dominant roles in the physico-chemical processes that govern drug release kinetics and delivery vehicle distribution.

Vaginal delivery of contraceptives

Although a steady increase in contraceptive use has been observed both in developed and less-developed countries, the large number of unplanned pregnancies may indicate that the contraceptive needs of a significant percentage of couples have so far not been met. Several new contraceptive products have reached the market during the last 2 years. Among these is a new contraceptive vaginal ring, which has become available for prescription. This new female method has been developed to expand the contraceptive choices available to couples. This review will address the specifics of the vaginal route for delivering contraceptive steroids and describe the various systems available or under evaluation.

Embodied expertise: women’s perceptions of the contraception consultation

This research, based on qualitative interviews and non-participant observation, emerges from a larger study investigating what factors influence the 'contraceptive careers' of British women in their 30s. The women informants recognized that contraceptive products often impacted on their health, but viewed them as distinct from 'medical matters'. Rather than doctors being seen as having expertise, it was women health professionals, be they nurses, midwives, health visitors or doctors, who were perceived as the ones who 'know' about contraception, through an assumption that they are contraception users. This embodied knowledge is valued by the women above their formal medical training. I will also show how general practice surgeries and family planning clinics were viewed as gendered spaces, which altered the expectations and experiences of the women during contraceptive consultations. This study found that as 'real' expertise over contraception stems from embodied rather than textual knowledge, the women's choices were grounded by a gendered sense of trust.

Patient Survey Data from a Prospective Randomized Controlled Trial Comparing the Use of Nuvaring® to Desogen® in In Vitro Fertilization Cycles with Ganirelix Acetate

Background and Significance: NuvaRing® is a relatively new contraceptive product that provides drug delivery of 15 μg ethinyl estradiol and 120 μg etonogesterol via a vaginal ring. This product provides contraceptive users with several advantages, such as low ethinyl estradiol level, and one time administration of the ring for up to 3 weeks. NuvaRing® has not been yet been utilized in scheduling IVF cycles.

Book review

Book review

What women want and what their doctors need – how do women evaluate the quality of contraceptive methods and products introduced by their gynaecologist? A different perspective

Is a doctor really aware of women's expectations and needs when choosing their contraceptive? When faced with making a decision about which contraceptive to chose, women often turn to their doctor for information and guidance. This is particularly the case with oral hormonal contraceptives. Nowadays women often demand more than just a pill that will provide reliable contraception – they expect additional benefits such as good cycle control, improvement in dysmenorrhoea and if possible a beneficial effect on hair and skin. The increased choice of available oral contraceptives places additional pressure on doctors to fully understand the products they are prescribing, in terms of both the physiological and the psychological effects they may have on their patients. Clinical guidelines need to be in place in order to manage any day-to-day problems that may arise. In addition doctors need to re-evaluate their relationship with their patients in order to provide what women really want.