(Norethindrone and Ethinyl Estradiol Tablets USP)
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.
Media Articles Related to Leena (Norethindrone / Ethinyl Estradiol)
Many women seeking medical care have experienced reproductive coercion and intimate partner violence
Source: Pregnancy / Obstetrics News From Medical News Today [2014.03.01]
Enough women experience reproductive coercion - male behavior to control contraception and pregnancy outcomes - that a research team now recommends health care providers address the subjects with their patients and tailor family planning discussions and recommendations accordingly.
Research shows women trying hard to avoid unwanted pregnancy
Source: Abortion News From Medical News Today [2014.02.04]
Most women experiencing unwanted pregnancy report they used a contraceptive at the time they conceived, data released by the British Pregnancy Advisory Service (bpas) shows. Older women undergoing abortion were less likely to have used contraception than women under 30, which may reflect their belief they are no longer fertile.
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)...
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
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.