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.

See all Seasonale indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Seasonale (Levonorgestrel / Ethinyl Estradiol)

Haemostatic effects of a new combined oral contraceptive, nomegestrol acetate/17beta-estradiol, compared with those of levonorgestrel/ethinyl estradiol. A double-blind, randomised study. [2011.03]
Use of oral contraceptives (OC) that combine a progestogen with synthetic ethinyl estradiol (EE) is associated with increased risk of venous thromboembolism. NOMAC/E2 is a new monophasic OC that combines nomegestrol acetate (NOMAC), a highly selective progestogen, with 17beta-estradiol (E2)...

Continuous, daily levonorgestrel/ethinyl estradiol vs. 21-day, cyclic levonorgestrel/ethinyl estradiol: efficacy, safety and bleeding in a randomized, open-label trial. [2009.12]
BACKGROUND: This Phase 3, randomized, open-label, multicenter study conducted at 44 sites in Europe evaluated the safety and efficacy of a continuous, daily regimen of levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg compared with a 21-day, cyclic LNG 100 mcg/EE 20 mcg regimen... CONCLUSIONS: Continuous LNG 90 mcg/EE 20 mcg was shown to be a safe and effective OC in this direct comparison to a cyclic OC. Suppression of menses and the potential for no bleeding requiring sanitary protection may be provided by this continuous, low-dose OC.

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...

more studies >>

Clinical Trials Related to Seasonale (Levonorgestrel / Ethinyl 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

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 [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).

Quartet Lead and Resynchronization Therapy Options [Completed]
The purpose of this Clinical Trial is to determine the percentage of patients whose hemodynamic response improves with the different configurations offered by the new Quartet® left ventricular lead, as a result of its four electrodes, with respect to the configurations offered by a standard bipolar lead. Furthermore, the optimal stimulation configuration will be determined from a comparison with traditional configurations.

more trials >>

Reports of Suspected Seasonale (Levonorgestrel / Ethinyl Estradiol) Side Effects

Pain (2),  Pulmonary Embolism (2),  Drug Effect Decreased (2),  Product Substitution Issue (1),  Thrombosis (1),  Haemorrhage (1),  Medication Error (1),  Abdominal Distension (1),  Muscle Spasms (1),  Cardiolipin Antibody Positive (1), more >>

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 48 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		birth control
Dosage & duration:		1 pill per day taken once a day for the period of 2 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The benefits of Seasonale is that you only have your period once every three months.
Side effects:		In my situation, I continually have spot bleeding towards the end of every 30 day cycle which should not occur. My doctor advised that this would lessen the longer I stay on this medication however, it only improved slighty and I never can make it through the entire 90 days, my period always starts a few days before I've finished the last few pills.
Comments:		You take one pill every day for 90 days, wait 7 days, and then begin the cycle again.

Seasonale review by 19 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		birth control
Dosage & duration:		n/a (dosage frequency: everyday) for the period of 1 year
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		only 4 periods a year
Side effects:		had spot bleeding all the time, everyday. my period was light though. had clear skin before and have bad acne once i started taking them. get severe headaches and stomach aches. usto take depo shot and would much rather take it than seasonale. am only taking seasonale because you can only take the depo for 2 years then you have to take a one year break. so far have gained 25 plus pounds, when was on depo i lost weight.
Comments:		efective against pregnancy.. thats about all.