Seasonale (Levonorgestrel / Ethinyl Estradiol) - Summary

SEASONALE SUMMARY

Seasonale® (levonorgestrel/ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 white inert tablets (without hormones). The chemical formula of levonorgestrel USP is 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17(alpha))-, (-)-, and the chemical formula of ethinyl estradiol USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17(alpha))-.

Seasonale® tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

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NEWS HIGHLIGHTS

Published Studies Related to Seasonale (Levonorgestrel / Ethinyl Estradiol)

A 1-year randomized study to evaluate the effects of a dose reduction in oral contraceptives on lipids and carbohydrate metabolism: 20 microg ethinyl estradiol combined with 100 microg levonorgestrel. [2005.02]
OBJECTIVES: To evaluate the impact on lipid and carbohydrate variables of a combined one-third ethinyl estradiol (EE)/levonorgestrel (LNG) dose reduction in oral contraceptives... CONCLUSION: Similar effects on the lipid and carbohydrate profiles were found for both preparations. The balanced one-third EE dose reduction in this new oral contraceptive caused slightly lower, but insignificant, changes in the lipid and carbohydrate variables compared with the reference treatment.

Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel: a randomized trial. [2005.02]
BACKGROUND: This trial was conducted to compare cycle control with vaginal ring a combined contraceptive vaginal ring, and a combined oral contraceptive (COC) delivering 30 mug ethinylestradiol (EE) and 150 mug levonorgestrel... CONCLUSIONS: Cycle control with vaginal ring was excellent and superior to that of a COC containing 30 mug EE.

A comparative study of monophasic oral contraceptives containing either drospirenone 3 mg or levonorgestrel 150 microg on premenstrual symptoms. [2005.01]
This open-label randomized study compared the effects of two combined oral contraceptives (OCs) containing 3 mg drospirenone (DRSP)/30 microg ethinyl estradiol (EE) with 150 microg levonorgestrel (LNG)/30 microg EE on the prevalence and changes from baseline of premenstrual symptoms after six cycles...

Double-blind, randomized study comparing the effects of two monophasic oral contraceptives containing ethinylestradiol (20 microg or 30 microg) and levonorgestrel (100 microg or 150 microg) on lipoprotein metabolism. [2004.02]
The effects of two monophasic oral contraceptives containing ethinylestradiol 20 microg in combination with levonorgestrel 100 microg (EE20/LNG100) or 30 microg and 150 microg (EE30/LNG150), respectively, on lipoprotein metabolism was investigated in a double-blind, randomized study of 12 treatment cycles in healthy female volunteers...

The effect of low dose nylestriol-levonorgestrel replacement therapy on bone mineral density in women with postmenopausal osteoporosis. [2003.05]
OBJECTIVE: Recently our studies have shown that nylestriol in combination with levonorgestrel prevented bone loss, decreased bone turnover rate and increased the maximal loading of bone without obvious side effects in retinoic acid (RA) induced osteoporotic rats. In addition to the animal experiments, we evaluate the effect of Compound Nylestriol Tablet (CNT) on bone mineral density (BMD) in women with postmenopausal osteoporosis. Compound Nylestriol Tablet, which contains 0.5 mg of nylestriol (cyclopentylethinyl estriol) and 0.15 mg of levonorgestrel per tablet, was authorized as a new anti-osteoporotic agent for clinical trial in postmenopausal osteoporosis... CONCLUSION: These data suggested that CNT is effective, safe and convenient in treating postmenopausal osteoporosis.

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Clinical Trials Related to Seasonale (Levonorgestrel / Ethinyl Estradiol)

A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale. [Active, not recruiting]
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

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.

AZD6140 Oral Contraceptive Interaction Study [Recruiting]

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 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).

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PATIENT REVIEWS / RATINGS / COMMENTS

Seasonale review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		birth control
Dosage & duration:		1/day (dosage frequency: daily for 91 days) for the period of 3 years
Other conditions:		none
Other drugs taken:		zoloft
		Reported Results
Benefits:		you take the pills for 90 days, daily. You only get your period 4 times/year. Some people have breakthough bleeding but I didn't have any bleeding. I didn't take the placebos, I started the next 90 day pack of pills and skipped my period.
Side effects:		I really didn't have any side effects other than no getting my period.
Comments:		1 pill per day for 90 days then 7 days of placebo

Seasonale review by 27 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		irregular cycles
Dosage & duration:		1 pill per day taken once per day for the period of ~1.5 years
Other conditions:		Raynaud's
Other drugs taken:		none
		Reported Results
Benefits:		No irregular cycles right now, very little cramping or other PMS symptoms.
Side effects:		Cannot take a birth control pill for more than ~24 months without side effects arising (i.e. mood swings, bowel change, spotting which was not present when I first started the medication, etc.) Seasonale is just the next medication to take until I can save enough money and/or convince my insurance company to pay for a hysterectomy. I have been on birth control for 12 years to control irregular cycles (imagine 50 day cycle followed by 15 day cycle) and intense PMS symptoms. I have recently developed Raynaud's and am increasingly worried about my fibrinogen levels due to birth control (specifically contraceptives containing estrogen such as Seasonale and every other birth control pill I've ever been on). I should also mention, I eat well at least 85% of the time (fast food/greasy take-out maybe once every other week) and exercise (combo of yoga, pilates, cardio, weightlifting) at least three days a week.
Comments:		Pill once a day at the same time every day avoiding grapefruit juice for at least 4 hours before and after dosing.

Seasonale review by 34 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		birth control
Dosage & duration:		as prescribed (dosage frequency: 2 years) for the period of 2 years
Other conditions:		depression
Other drugs taken:		prozac
		Reported Results
Benefits:		Premenstral syndrome was diminished.
Side effects:		Weight gain. I wonder if there is a connection to developing ovarian cysts because of the reduced number of periods.
Comments:		I take it at night before I sleep.