Levora (Levonorgestrel / Ethinyl Estradiol) - Summary

LEVORA SUMMARY

WATSON PHARMA
Revised: May 2005
IN-5262/S
PHYSICIAN LABELING
Levora ^® 0.15/30-28
(levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg)
Rx only

Levora ^® 0.15/30-28 Tablets provide an oral contraceptive regimen consisting of 21 white tablets containing levonorgestrel 0.15 mg and ethinyl estradiol 0.03 mg followed by 7 peach tablets containing inert ingredients. Levonorgestrel is a totally synthetic progestogen with the chemical name (–)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen with the chemical name 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-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 Levora indications & dosage >>

NEWS HIGHLIGHTS

Clinical Trials Related to Levora (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.

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

Levora review by 31 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Birth Control Pill
Dosage & duration:		.15/.03 (dosage frequency: daily) for the period of 5 years
Other conditions:		Irregular Menstrual Cycles, Painful Menstruations
Other drugs taken:		none
		Reported Results
Benefits:		The pills regulated my menstrual cycle and reduced the occurance of cramps (so severe that I was often bed ridden). Other birth control pills that I had taken previously had undesirable side effects, such as weight gain, which I have not experienced with Levora.
Side effects:		I have headaches, and occasionally migraines, during my menstruation.
Comments:		One pill, once a day, preferably around the same time.

Levora review by 28 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Contraception
Dosage & duration:		one pill a day taken 4 months and then 1 week of placebo for the period of 1 year
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		protection against pregnancy.
Side effects:		decreased vaginal lubrication and sex drive
Comments:		I take the pill continuously, skipping the placebos and thus my period for four months, followed by one week of placebos. My mood, energy and hormonal balance remain constant, particularly compared to other pills but unfortunately so has my sex drive. The changes in sexual feelings are clearly related to the pill because as soon as I take the placebos I experience a huge elevation in sex drive. That is not much motivation to keep taking them but aside from spermicidal barrier methods that cause irritation and invasive procedures such as the IUD, I don't know what other options I have.