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Nordette (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.

 

NORDETTE SUMMARY

NORDETTE®-28 TABLETS
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS)

21 light-orange Nordette tablets, each containing 0.15 mg of levonorgestrel, (d (-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and 7 pink inert tablets.

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

Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.


See all Nordette indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Nordette (Levonorgestrel / Estradiol)

Teens and Women Aged 35+ Least Likely to Use Contraception
Source: Medscape Headlines [2015.08.28]
Dr Peter Kovacs says that a new analysis of factors associated with nonuse of contraception can be used to identify women at risk for unplanned pregnancy.
Medscape Ob/Gyn

Domestic violence deters contraception
Source: Abortion News From Medical News Today [2015.04.02]
Domestic violence takes many forms. The control of a woman's reproductive choices by her partner is one of them.

'15 million unwanted pregnancies' created by low contraception in 35 poorer countries
Source: Abortion News From Medical News Today [2015.02.05]
Some 90% of the 16.7 million unwanted pregnancies across a third of the world's population every year are due to a failure to use modern contraception, study suggests.

Research reveals more than half of young women who have abortions were using contraception when they fell pregnant
Source: Abortion News From Medical News Today [2014.04.30]
Reproductive health charity Marie Stopes UK has launched the findings of the first research in the UK into the contraceptive use of women aged 16-24 having one or more abortions.

Female cystic fibrosis patients need more contraceptive guidance, study finds
Source: Cystic Fibrosis News From Medical News Today [2015.05.11]
As life span for once-deadly disease increases, unplanned and mistimed pregnancies are commonOnly half of women with cystic fibrosis (CF) report using contraception and frequently apt to become...

more news >>

Published Studies Related to Nordette (Levonorgestrel / Estradiol)

Effect of ticagrelor on the pharmacokinetics of ethinyl oestradiol and levonorgestrel in healthy volunteers. [2011.08]
BACKGROUND: Cytochrome P450 3 A is involved in ticagrelor and ethinyl oestradiol/levonorgestrel metabolism; so a potential drug-drug interaction may occur. OBJECTIVES: To assess: ticagrelor effects on ethinyl oestradiol/levonorgestrel pharmacokinetics, endogenous sex hormone levels; ethinyl oestradiol/levonorgestrel effects on ticagrelor pharmacokinetics; tolerability of ticagrelor + ethinyl oestradiol/levonorgestrel... CONCLUSIONS: Ticagrelor co-administration with ethinyl oestradiol/levonorgestrel increased ethinyl oestradiol exposure by approximately 20%, with no effect on levonorgestrel pharmacokinetics. No clinically relevant effect on contraceptive efficacy is expected with ethinyl oestradiol/levonorgestrel and ticagrelor co-administration.

Comparative effects of a contraceptive vaginal ring delivering a nonandrogenic progestin and continuous ethinyl estradiol and a combined oral contraceptive containing levonorgestrel on hemostasis variables. [2006.07]
OBJECTIVE: This study aimed to compare the effects on hemostasis variables of a contraceptive vaginal ring with those of an oral contraceptive... CONCLUSION: The contraceptive vaginal ring affected some measured hemostasis variables and sex hormone-binding globulin differently from the oral contraceptive, most likely because of difference in androgenicity of the progestins. The results suggest that the contraindications for oral contraceptive use would also apply to the tested contraceptive vaginal ring.

Effect of two oral contraceptives with different ethinyl estradiol and levonorgestrel concentrations on the urinary excretion of biochemical vasoactive markers. [2001.12]
In the present study the effect on the urinary excretion of vasoactive markers of two oral contraceptives (OCs), i.e., Leios, containing 0.02 mg ethinyl estradiol and 0.1 mg levonorgestrel, and Stediril 30, containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel, was investigated... Levonorgestrel may elicit no impact on these estrogen-induced changes that, however, seem only to be manifested after a longer treatment period.

A prospective randomized study comparing the clinical effects of a norethisterone and a levonorgestrel containing low dose oestrogen oral contraceptive pills. [1993.02]
The two types of low dose oral contraceptives one containing levonorgestrel the other containing norethisterone have been compared in a randomized prospective study. We have found that cycle control was much poorer with the norethisterone pill and would therefore recommend that if the norethisterone-containing pill needs to be prescribed then either the 1 mg or the 'synphasic' preparation should be considered..

A clinical comparison of two triphasic oral contraceptives with levonorgestrel or norethindrone: a prospective, randomized, single-blind study. [1993.01]
Menstrual bleeding patterns were investigated in young women taking either a levonorgestrel triphasic, Triquilar, or a norethindrone triphasic, Ortho 7/7/7, two commonly prescribed low-dose oral contraceptives. The levonorgestrel triphasic contains ethinyl estradiol (EE) 30 micrograms + levonorgestrel (LNG) 50 micrograms for the first six days, EE 40 micrograms + LNG 75 micrograms for the following five days, and EE 30 micrograms + LNG 125 micrograms for the last ten days...

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Clinical Trials Related to Nordette (Levonorgestrel / Estradiol)

AZD6140 Oral Contraceptive Interaction Study [Completed]

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

Evaluation Of The Product Ciclo® 21 Pharmacodynamics (Levonorgestrel + Ethinyl Estradiol), Marketed By União Química Farmacêutica Nacional S / A, Compared To Nordette® Product To The Lab Wyeth Pharmaceutical Industries Ltd. [Not yet recruiting]
Assessment of the pharmacodynamic profile of the drug Ciclo 21 ®, marketed by União Química Farmacêutica Nacional S / A, compared to the drug Nordette ® Laboratory Wyeth Pharmaceutical Ltda. Through the modulation of hormonal response (inhibition of the pituitary) evidenced by measurement serum LH and FSH for 28 days, as well as by the absence of follicle formation demonstrated by transvaginal ultrasound examinations

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 1 ratings/reviews, Nordette has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
 

Nordette review by 46 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   pregnancy avoidance
Dosage & duration:   1 pill taken daily for the period of 8 years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   pregnancy avoidance, worked perfectly, did not get pregnant until stopped taking the meidaction, then 3 months later conceived
Side effects:   none - no apparent side effects whatsoever. periods were normal when on inert pills. Periods came like clockwork
Comments:   basic - took nordette before and after bearing children. switched to mirena iud after child bearing years

See all Nordette reviews / ratings >>

Page last updated: 2015-08-28

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