BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
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SEASONIQUE SUMMARY
SEASONIQUETM
(levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg and
(ethinyl estradiol tablets) 0.01 mg
SeasoniqueTM (levonorgestrel/ethinyl estradiol combination tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol.
SeasoniqueTM tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Clinical Studies
PSE-301 was a randomized, multicenter, open-label study designed to evaluate the safety and efficacy of SeasoniqueTM for approximately 1 year (four 91-day SeasoniqueTM extended cycles). A total of 1,006 sexually active adult women of childbearing potential, 18 to 40 years of age, were treated and completed 2,488 SeasoniqueTM 91-day cycles. The principal cohort for efficacy included only patients 18 to 35 years of age who completed at least one 91-day cycle treatment cycle. Cycles in which another form of birth control was used (including condoms) were excluded from the efficacy analysis. The overall Pearl Index was 1.77, based on 7 pregnancies in 1,578 completed 91-day treatment cycles.
Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® Implant System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
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NEWS HIGHLIGHTSMedia Articles Related to Seasonique (Levonorgestrel / Estradiol / Estradiol)
US funding revamps African contraceptive drive (AFP)
Source: Y! Health News Search RSS Feed [2009.11.18]
AFP - A new 12 million dollar family planning drive launched here Wednesday highlights how Obama administration funding has revamped a contraception drive in Africa and developing states, UN officials said, noting a sharp turnaround from the Bush era.
Terrence Higgins Trust Welcomes Department Of Health Nursing Degree Announcement, UK
Source: HIV / AIDS News From Medical News Today [2009.11.15]
HIV and sexual health charity Terrence Higgins Trust has welcomed the announcement by the Department of Health that all new nurses will be educated to degree level from 2013. Terrence Higgins Trust (THT) currently employs nurses who work in Chlamydia screening programmes for young people, HIV testing clinics and clinics that offer contraception services and screening for sexually transmitted infections.
Clinical Trials Related to Seasonique (Levonorgestrel / Estradiol / Estradiol)
AZD6140 Oral Contraceptive Interaction Study [Recruiting]
A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens [Completed]
This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy,
reproductive-aged women using three different regimens of oral contraceptives (OCs). Two
extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0. 15/0. 03 mg for 84 days
followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0. 15/0. 03 mg
for 84 days followed by 7 days of ethinyl estradiol 0. 01 mg), and a 28-day regimen OC, Portia
(levonorgestrel/ethinyl estradiol 0. 15/0. 03 mg for 21 days followed by 7 days of placebo).
A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil. [Completed]
The purpose of the study was to compare the contraceptive efficacy and safety of the
transdermal patch to Triphasil.
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain [Completed]
This study is being conducted to evaluate the effects of treatment with Seasonique an
extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the
typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall
study duration will be approximately 9 months. Patients will be required to record menstrual
pain in a daily diary.
Study to Evaluate the Safety and Efficacy of Seasonale for Treatment of Low Bone Mineral Density [Withdrawn]
This is a randomized, multicenter, placebo-controlled study to evaluate the effects of
Seasonale, an extended-regimen oral contraceptive, on bone mineral density in adolescent
females who have had their menstrual period but now have secondary amenorrhea and also have
osteopenia. The duration of the study for each patient will be approximately two years.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 11 ratings/reviews, Seasonique has an overall score of 5.36. The effectiveness score is 8.73 and the side effect score is 5.64. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Seasonique review by 18 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | unregulated periods |
| Dosage & duration: | | 1 pill per day taken 1 pill per day for the period of few weeks |
| Other conditions: | | n/a |
| Other drugs taken: | | n/a | | |
Reported Results |
| Benefits: | | I was on YAZ for over a year, played on three soccer teams (two were for high school) and still gained 5 lbs. After i switched to seasonique a few weeks ago, i lost my appetite and lost weight. I dont eat nearly as much now. Im 5'0'' and before i switched i used to weigh roughly around 115... now im sticking around 105. i have no experience with the bad side effects with seasonique |
| Side effects: | | none |
| Comments: | | one pill a day at the same time |
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| | Seasonique review by 20 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | preventing pregnancy |
| Dosage & duration: | | 1 pill every day for 3 months taken 1 pill everyday for 3 months for the period of 9 months |
| Other conditions: | | N/A |
| Other drugs taken: | | N/A | | |
Reported Results |
| Benefits: | | Highly effective at preventing pregnancy. |
| Side effects: | | I am 20 years old and I have been usuing Seasonique for 9 months. The reason I have used it this long is because despite the side effects of continuous breakthrough bleeding, I have been away at school and unable to visit my doctor for anew prescription. I am sexually active and did not want to take myself off birth control. DO NOT TAKE SEASONIQUE. For the first two months everything was OK, minus occasional extreme cramps. But I am on my third month of my third pack, and I have had breakthrough bleeding for TWENTY FIVE DAYS now. This does not only scare me in health areas, but it is making me extremely depressed. |
| Comments: | | N/A |
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| | Seasonique review by 26 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | To prevent pregnancy |
| Dosage & duration: | | 1 pill a day taken 1 pill a day for the period of 4 weeks |
| Other conditions: | | nausea, breakouts, mood swings |
| Other drugs taken: | | the Pill, depo-provera | | |
Reported Results |
| Benefits: | | 4 periods a year |
| Side effects: | | The first week that I took this pill, I felt like I had the flu. I had to take a sick day off from work because I felt so sick: headache, constantly feeling hot and cold, extreme tiredness. I also started breaking out a lot and my skin started to be so dry. My husband also has said that I've had some mood swings as well. |
| Comments: | | I stopped taking the pills today. I hope this will stop all the symptoms. I will probably never take any birth control for the rest of my life. I was on Depo for about 2 years, which was fine--no major side effects except for the decreased sex drive. I was on Ortho Tri Cyclen for about a year before Depo, but I stopped because I definitely got lighter periods but the periods were longer (5 days) than when I was not on any BC (3 days).
I shouldn't have been on any BC to begin with. Afterall, I shouldn't complain--my periods are always on time like clock work. No cramps, only the occasional bloating. I started to be on BC to prevent pregnancy, but I'll just be more careful by using a condom instead. |
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Page last updated: 2009-11-18
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