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)
6 in 10 of America's Single Guys 'Take Responsibility' for Contraception
Source: MedicineNet Vasectomy Specialty [2017.08.31]
Title: 6 in 10 of America's Single Guys 'Take Responsibility' for Contraception
Category: Health News
Created: 8/31/2017 12:00:00 AM
Last Editorial Review: 8/31/2017 12:00:00 AM
Clinical Trials Related to Seasonique (Levonorgestrel / Estradiol / Estradiol)
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale [Completed]
This is a 4-arm study to evaluate and compare bleeding patterns between three different
doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants
will receive physical and gynecological exams, including Pap smear. During the study, all
participants will be required to complete a diary
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.
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 13 weeks of treatment with the option
to extend blinded therapy for an additional 13 weeks. The overall study duration will be
6-9 months. Patients will be required to record menstrual pain in a daily diary.
AZD6140 Oral Contraceptive Interaction Study [Completed]
Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects [Completed]
This open-label, fixed-sequence crossover study aims to evaluate the effect of GSK1265744
(744) oral administration on the pharmacokinetics (PK) and pharmacodynamics (PD) of a
commonly used oral contraceptive (OC) product (combination of ethinyl estradiol and
levonorgestrel), in 20 healthy female subjects. Each subject will participate in a Run-in
Period (if needed), followed by a single-sequence Treatment Period. Subjects will receive
oral contraceptive containing Levonorgestrel and Ethinyl Estradiol on Days 1 to 21 and be OC
free on Days 22 to 28, during which withdrawal menses should occur. Subjects will receive OC
alone on Days 1 to 10. Levonorgestrel (LNG) and ethinyl estradiol (EE) PK will be determined
on Day 10. Subjects will then co-administer 744 and OC on Days 11 to 21. Levonorgestrel
and ethinyl estradiol PK will be determined again on Day 21 to assess if co-administration
with 744 results in a significant change in OC exposure compared to OC alone. Subjects will
return to the study center for final follow-up evaluations 7 to 14 days after the last dose
of study medication (Days 28 to 35).
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: 2017-08-31
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