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Alesse (Levonorgestrel / Ethinyl Estradiol) - Summary

 
 



BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular side effects from oral-contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

 

ALESSE SUMMARY

IMPORTANT POINTS TO REMEMBER

21 pink active tablets each containing 0.10 mg of levonorgestrel, d(-)-13(beta)-ethyl-17(alpha)-ethinyl-17(beta)-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17(alpha)-ethinyl-1,3,5(10)-estratriene-3, 17(beta)-diol.

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.


See all Alesse indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Alesse (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...

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Clinical Trials Related to Alesse (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

AZD6140 Oral Contraceptive Interaction Study [Completed]

Observational Trial With Leios/Alesse [Completed]
A prospective, observational study (Anwendungsbeobachtung [AWB]) of the prescribing and administration practices of German gynecologists with Leios® Dragées.

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.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Alesse has an overall score of 8.50. The effectiveness score is 10 and the side effect score is 9. The scores are on ten point scale: 10 - best, 1 - worst.
 

Alesse review by 24 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   PREVENT PREGNANCY
Dosage & duration:   1 PILL taken once a day for 28 days for the period of 2 YEARS
Other conditions:   HPV
Other drugs taken:   NONE
  
Reported Results
Benefits:   THE PILL WORKED VERY WELL WITH MY BODY. IT DIDN'T HAVE ANY SIDE EFFECTS ON ME LIKE SOME OTHER BIRTH CONTRACEPTION PILLS
Side effects:   I DID NOT HAVE ANY NOTICEABLE SIDE EFFECTS
Comments:   TAKE THE PILL ONCE A DAY ABOUT THE SAME TIME FOR 28 DAYS AND THEN STOP TAKING IT FOR A WEEK TO START MY MENSTRUAL CYCLE.

 

Alesse review by 20 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   pregnancy prevention
Dosage & duration:   1 pill taken daily for the period of 1 1/2 years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Pregnancy prevention, regulation of menstrual cycle.
Side effects:   nausea, headache, dizziness, blurred vision, decreased libido. not severe, but also not enjoyable. The symptoms seem to be getting very gradually more noticeable, but it could be due to other things, such as increased stress.
Comments:   Take an active pill at the same time each day for 21 days, and take no pills for 7 days, during which your period should arrive. Resume the next pack after 7 days of no pills.

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Page last updated: 2011-12-09

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