Leena (Norethindrone / Ethinyl Estradiol) - Summary

LEENA SUMMARY

WATSONPHARMA
IN-5264/S
PHYSICIAN LABELING
Leena ™
(Norethindrone and Ethinyl Estradiol Tablets USP)
Rx only

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Leena™ provides a continuous oral contraceptive regimen of 7 light blue tablets, 9 light yellow-green tablets, 5 more light blue tablets, and then 7 orange tablets. Each light blue tablet contains norethindrone 0.5 mg and ethinyl estradiol 0.035 mg, each light yellow-green tablet contains norethindrone 1 mg and ethinyl estradiol 0.035 mg, and each orange tablet contains inert ingredients.

Norethindrone is a potent progestational agent with the chemical name 17-Hydroxy-19-nor-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.

Oral contraceptive products such as Norinyl, which contain 50 mcg of estrogen, should not be used unless medically indicated.

See all Leena indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Leena (Norethindrone / Ethinyl Estradiol)

Millions Still Lack Access to Modern Contraception, Study Says
Source: MedicineNet Birth Control Specialty [2013.03.12]
Title: Millions Still Lack Access to Modern Contraception, Study Says
Category: Health News
Created: 3/11/2013 8:36:00 PM
Last Editorial Review: 3/12/2013 12:00:00 AM

Give Teens Access to Emergency Contraception, Pediatricians Say
Source: MedicineNet Miscarriage Specialty [2012.11.26]
Title: Give Teens Access to Emergency Contraception, Pediatricians Say
Category: Health News
Created: 11/26/2012 10:35:00 AM
Last Editorial Review: 11/26/2012 12:00:00 AM

Copper IUD Does Not Increase Period Pain
Source: Sexual Health / STDs News From Medical News Today [2013.05.10]
Previous scientific studies have suggested that women who use a copper IUD for contraception suffer from worse period pain, but a study at the Sahlgrenska Academy, University of Gothenburg, that followed 2,100 women over a 30-year period shows that this is not the case...

more news >>

Published Studies Related to Leena (Norethindrone / Ethinyl Estradiol)

Efficacy, cycle control, and safety of two triphasic oral contraceptives: Cyclessa (desogestrel/ethinyl estradiol) and ortho-Novum 7/7/7 (norethindrone/ethinyl estradiol): a randomized clinical trial. [2000.05]
The contraceptive efficacy, cycle control, and safety of a new low-dose, triphasic desogestrel/ethinyl estradiol oral contraceptive (CTR 77, Cyclessa(TM)) was compared to that of a marketed, triphasic norethindrone/ethinyl estradiol oral contraceptive (Ortho-Novum(R) 7/7/7).Cyclessa provides significantly improved cycle control with no weight gain.

Cycle control with oral contraceptives containing 20 micrograms of ethinyl estradiol. A multicenter, randomized comparison of levonorgestrel/ethinyl estradiol (100 micrograms/20 micrograms) and norethindrone/ethinyl estradiol (1000 micrograms/20 micrograms). [1999.03]
A randomized, open-label, multicenter study was undertaken to compare the effects of oral contraceptives (OC) containing 100 micrograms levonorgestrel (LNG)/20 micrograms ethinyl estradiol (EE) (Aless/Loette) and 1000 micrograms norethindrone acetate (NETA)/20 micrograms EE (Loestrin Fe 1/20) on menstrual cycle control over four cycles of use...

Multicenter randomized comparative trial of two low-dose triphasic combined oral contraceptives containing desogestrel or norethindrone. [1994.05]
OBJECTIVE: To compare a new triphasic oral contraceptive (OC) containing desogestrel and ethinyl estradiol (DSG/EE) with triphasic norethindrone/ethinyl estradiol (NE/EE) regarding effects on clinical efficacy, cycle control, and safety indices... CONCLUSION: Triphasic DSG/EE is an effective and safe OC with excellent acceptability and cycle control superior to that of triphasic NE/EE.

Pharmacokinetics of three bioequivalent norethindrone/mestranol-50 micrograms and three norethindrone/ethinyl estradiol-35 micrograms OC formulations: are "low-dose" pills really lower? [1989.09]
We have examined the pharmacokinetic parameters derived from the analysis of plasma ethinyl estradiol (EE) and norethindrone levels after administration of a single dose of three bioequivalent norethindrone-1mg/mestranol (ME)-50 micrograms formulations (Ortho-NovumR 1/50, NorinylR 1/50 and Norcept-MR 1/50) and three norethindrone-1mg/ethinyl estradiol-35 micrograms formulations (Ortho-Novum 1/35R, NorinylR 1/35, Norcept-ER 1/35) in a randomized crossover design involving 24 women for the 35 micrograms and 27 women for the 50 micrograms agents...

Bleeding patterns of women using Lunelle monthly contraceptive injections (medroxyprogesterone acetate and estradiol cypionate injectable suspension) compared with those of women using Ortho-Novum 7/7/7 (norethindrone/ethinyl estradiol triphasic) or other oral contraceptives. [2000.12]
Persistent and/or unpredictable bleeding is a common reason for discontinuation of hormonal contraceptive methods. An open-label, nonrandomized, parallel, controlled study compared the efficacy, safety, and cycle control of the new, highly efficacious monthly injectable contraceptive containing 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate (E(2)C) (MPA/E(2)C) (Lunelle Monthly Contraceptive Injection) with that of the frequently used norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum 7/7/7)...

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Clinical Trials Related to Leena (Norethindrone / Ethinyl Estradiol)

Study of Hsp90 Inhibitor, STA-9090 for Relapsed or Refractory Small Cell Lung Cancer [Recruiting]
STA-9090 blocks Heat Shock Protein-09 (Hsp90), which is thought to be involved in regulating apoptosis or cell death in small cell lung cancer.

In this research study, the investigators will look to see if STA-9090 has a therapeutic effect on small cell lung cancer. The investigators will also study the safety of STA-9090 and whether measuring circulating tumor cells may help in assessing response to treatment.

Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer [Recruiting]
Pazopanib is a drug that inhibits proteins thought to be important for new blood vessel formation. This drug has been used in other cancer research studies and information from those studies suggests that pazopanib may help block proteins that are important for the growth, invasion, and spread of cancer cells.

In this research study, the investigators are looking:

- To see if pazopanib can shrink participant's tumor(s)

- To find out if pazopanib causes changes in blood/urine proteins associated with small

cell lung cancer

- To assess the use of perfusion CT scans for determining the effect of pazopanib on the

blood flow to the tumor

Effect of Actonel on Periodontal Health of Postmenopausal Women [Recruiting]
Hypothesis: Women who use Actonel (risedronate) for osteopenia will show beneficial periodontal effects.

Treatment of Non-Gestational Acute Uterine Bleeding: A Randomized Trial [Completed]
To determine the relative efficacy of multidose medroxyprogesterone acetate (MPA, Provera) and a multidose, monophasic combination oral contraceptive in the treatment of hemodynamically stable women with non-gestational, acute uterine bleeding.

Study of Safety and Efficacy of an Oral Contraceptive [Active, not recruiting]
This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.

more trials >>