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)
Millions Still Lack Access to Modern Contraception, Study Says
Source: MedicineNet Birth Control Specialty [2013.03.12]
Title: Millions Still Lack Access to Modern Contraception, Study Says
Category: Health News
Created: 3/11/2013 8:36:00 PM
Last Editorial Review: 3/12/2013 12:00:00 AM
Give Teens Access to Emergency Contraception, Pediatricians Say
Source: MedicineNet Miscarriage Specialty [2012.11.26]
Title: Give Teens Access to Emergency Contraception, Pediatricians Say
Category: Health News
Created: 11/26/2012 10:35:00 AM
Last Editorial Review: 11/26/2012 12:00:00 AM
Copper IUD Does Not Increase Period Pain
Source: Sexual Health / STDs News From Medical News Today [2013.05.10]
Previous scientific studies have suggested that women who use a copper IUD for contraception suffer from worse period pain, but a study at the Sahlgrenska Academy, University of Gothenburg, that followed 2,100 women over a 30-year period shows that this is not the case...
Clinical Trials Related to Seasonique (Levonorgestrel / Estradiol / Estradiol)
Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects [Recruiting]
A crossover study to assess the effect of repeated doses of fostamatinib on the levels of
oral contraceptive (Microgynon® 30) in the blood of healthy female subjects. The study will
consist of a screening period of up to 35 days, followed by 2 treatment periods (28 days
each) of an oral contraceptive (Microgynon® 30) in the absence and presence of fostamatinib.
The study will also evaluate the safety and tolerability of fostamatinib in combination
with an oral contraceptive
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 to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female Subjects [Recruiting]
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.
Reports of Suspected Seasonique (Levonorgestrel / Estradiol / Estradiol) Side Effects
Pain (3),
Hot Flush (3),
Night Sweats (2),
Endometriosis (2),
Pulmonary Embolism (2),
Menstruation Irregular (2),
Fatigue (2),
Dizziness (2),
Anaemia (2),
Bile Duct Obstruction (1), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 28 ratings/reviews, Seasonique has an overall score of 5.07. The effectiveness score is 8.43 and the side effect score is 5.21. 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 25 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Preventing Pregnancy |
| Dosage & duration: | | 3 month dose (dosage frequency: since june 2009) for the period of Since June 2009 |
| Other conditions: | | No Sex Drive |
| Other drugs taken: | | n/a | | |
Reported Results |
| Benefits: | | preventing pregnancy |
| Side effects: | | This pill was great b/c i didn't have any periods and also prevented pregnancy, but that doesn't help you don't have ANY sex drive. I didn't have any sex drive at all... not decreased. none at all. horrible. switching back to Ortho-Tricyclene lo. I'd been on that since 2002. |
| Comments: | | n/a |
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| | Seasonique review by 18 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | ovarian cysts. |
| Dosage & duration: | | N/A (dosage frequency: everyday.) for the period of 3 months. |
| Other conditions: | | none. |
| Other drugs taken: | | none. | | |
Reported Results |
| Benefits: | | To reduce pain during periods. |
| Side effects: | | High depression, anxiety attacks, heart palpitations. |
| Comments: | | The pill was nice to keep you off your period, i took my pill everyday at different times, but the side effects were effecting the way i was living. I couldn't handle the depression, and anxiety. I felt like i was losing it. During the pill use, i was getting dizzy spells, after a while i just felt like i couldn't handle going through a day. |
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Page last updated: 2013-05-10
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