Trivora (Levonorgestrel / Ethinyl Estradiol / Levonorgestrel / Ethinyl Estradiol / Levonorgestrel / Ethinyl Estradiol) - Summary

TRIVORA SUMMARY

PHYSICIAN LABELING
Trivora^®
(levonorgestrel and ethinyl estradiol tablets USP)
triphasic regimen
Rx only

Each Trivora cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 blue tablets, each containing 0.050 mg of levonorgestrel (d (-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 white tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 pink tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 peach inert tablets.

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

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NEWS HIGHLIGHTS

Media Articles Related to Trivora (Levonorgestrel / Estradiol / Levonorgestrel / Estradiol / Levonorgestrel / Estradiol)

LARC versus SARC: Major study demonstrates clear benefits of long-acting reversible contraception compared to short-acting reversible contraception
Source: Sexual Health / STDs News From Medical News Today [2016.09.22]
Benefits of increased voluntary uptake of LARC may extend to wider populations than previously thought, according to a major study in the American Journal of Obstetrics and Gynecology.

LARC Study: More Consistent Use, Lower Pregnancy Rate
Source: MedPage Today OB/Gyn [2016.09.22]
(MedPage Today) -- Advantages of long-acting reversible contraception affirmed

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Clinical Trials Related to Trivora (Levonorgestrel / Estradiol / Levonorgestrel / Estradiol / Levonorgestrel / 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]

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.

Quartet Lead and Resynchronization Therapy Options III [Not yet recruiting]
The purpose of the study is to assess prospectively at 6 months the percentage of responder patients implanted with a Cardiac Resynchronization Therapy (CRT-D) device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated.

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