Table of Contents
Chapters
- The Long Road of Contraceptive Development
- Vaginal Rings
- Transdermal Contraception
- Contraceptive Implants
- Combined Injectables
- Condoms
- Fertility Awareness-Based Methods
- Oral Contraceptives
- Intrauterine Devices
- Transcervical Female Sterilization
- Male Hormonal Contraception
- Bibliography
- Web Supplements
Highlights
Published by the INFO Project, Center for Communication Programs, the Johns Hopkins Bloomberg School of Public Health, 111 Market Place, Suite 310, Baltimore, Maryland 21202, USA
April 2005
Series M, Number 19
Special Topics |
Oral Contraceptives
New Oral Contraceptives
Description: Tracking one’s fertility and avoiding unprotected sex on fertile days.
Stage of development: Included in some programs.
Effectiveness: Standard Days Method—12 pregnancies per 100 women per year as typically used. TwoDay Method—14 pregnancies per 100 women per year as typically used.
How they work: Avoiding unprotected intercourse during days identified as probably fertile.
What’s new? Provide simplified ways to track fertile days with the use of colored beads or secretion diary. |
Pharmaceutical companies periodically introduce new OC formulations, usually focused on reducing side effects and so increasing continuation, while maintaining high effectiveness. Recently introduced OCs include a dedicated continuous-use formulation, a combined OC containing a new progestin, and a new progestin-only OC.
Continuous-Use Oral Contraceptives
More and more reproductive health experts are questioning the necessity for the monthly withdrawal bleed, which OC users experience while taking the seven inactive pills or seven days without pills in each month’s cycle (124, 242). New research has found that women can safely and effectively use many monophasic OCs continuously for a few cycles in a row, skipping the inactive pills (8, 163, 237, 238). (“Monophasic” means that each active pill in the cycle contains the same amount of hormones.)
Barr Labs
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Seasonale, a new continuous-use OC, comes in a 3-month supply. Women take 1 active pill per day for 84 days and then take inactive pills for 7 days. Continuous-use OCs reduce the number of bleeding days and related side effects. |
The monthly regimen of 21 active pills containing estrogen and progestin, followed by 7 inactive pills, was created to promote monthly withdrawal bleeding and to mimic spontaneous menstrual cycles (58). Taking active pills continuously allows women to reduce the number of times they experience monthly bleeding per year and to reduce the number of bleeding days (162). Continuous-use OCs also significantly reduce the side effects associated with hormone withdrawal, including migraines, headaches, premenstrual syndrome, mood changes, and heavy or painful monthly bleeding, which women experience primarily on the days they take the inactive pills (237, 238).
Women taking OCs continuously are about twice as likely as women using the conventional regimen to have breakthrough bleeding between periods, which leads many to discontinue use. Breakthrough bleeding and spotting diminish after about eight or nine months of use, however (8, 162). Researchers have studied a few different OCs for continuous use with different results in controlling breakthrough bleeding and other side effects (50, 163, 211).
One formulation, Seasonale®, is packaged specifically for continuous-use and is US FDA approved. It contains 150 µg of the progestin levonorgestrel and 30 µg of the estrogen ethinyl estradiol. Seasonale users take a pill every day for 84 days (12 weeks) and then take hormone-free pills for 7 days. Only 10 months after Seasonale became available, more than 260,000 prescriptions for it had been written in the US (73). Its developer, Barr Laboratories plans to apply for approval in other countries (60).
Drospirenone Combined
Oral Contraceptive
Drospirenone is the new progestin in the combined OC Yasmin®, developed by Schering AG. Yasmin contains 3 mg of drospirenone and 30 µg of the estrogen ethinyl estradiol (EE). Yasmin received US FDA approval in 2001 and is now available in Australia, the US, and Europe.
Drospirenone/EE pills are about as effective as other combined OCs in the first year of use (108, 182). The unique progestin drospirenone provides several benefits for some women in addition to preventing pregnancy (211, 243). For women who already experience acne and excess hair growth, clinical trials suggest that drospirenone/EE could reduce these conditions. Some clinical trials have found that drospirenone/EE causes less water retention and thus less fluid-related weight gain than other combined OCs (108, 177). Other trials have found that some users have an improved sense of well-being (13, 149, 201).
Side effects of drospirenone/EE are similar to those of other combined OCs and include headache, breast pain, nausea, and abdominal pain (108). Reports of several cases of venous thromboembolism (VTE) in the UK raised concerns about drospirenone increasing the risk of VTE (208). There is no epidemiological evidence, however, to suggest that users of combined OCs containing drospirenone have any greater risk of VTE than users of other combined OCs (103).
Desogestrel Progestin-Only
Oral Contraceptive
Desogestrel is the progestin in the new pill Cerazette®, developed by Organon. It is available primarily in Brazil, Ecuador, Hong Kong, Mexico, and some countries of Western Europe (114). Organon has not decided whether to apply for US FDA approval for Cerazette (138).
Users take a daily pill containing 75 µg of desogestrel. Unlike other progestin-only pills that work mainly by making cervical mucus thicker so that sperm cannot reach the egg, desogestrel works primarily by preventing ovulation (78, 132). Also, desogestrel is unique among progestin-only pills in that a woman can take a pill as much as 12 hours late without reducing effectiveness (132). In contrast, the effectiveness of other progestin-only pills may be compromised if pills are taken as few as three hours late (based on hormone levels) (33).
In clinical trials there were about 0.2 pregnancies per 100 women (2 pregnancies per 1,000 women) using desogestrel correctly in the first year of use, a rate similar to that of combined OCs (51). Some researchers, however, question whether there is enough evidence to say that desogestrel is as effective as combined OCs, because sufficient clinical trials directly comparing desogestrel and combined OC have not been completed (72).
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