NEWS HIGHLIGHTS
Published Studies Related to Levlite (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...
Clinical Trials Related to Levlite (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]
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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