(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.
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)
Covered Metal Stent for Benign Biliary Stricture Caused by Chronic Pancreatitis [Recruiting]
Benign biliary strictures caused by chronic pancreatitis can be endoscopically treated with
covered self-expandable metal stents (cSEMS).The purpose of the prospective randomized study
is to define the optimal duration of stenting and the diameter of the cSEMS.
Effect of Actonel on Periodontal Health of Postmenopausal Women [Recruiting]
Hypothesis: Women who use Actonel (risedronate) for osteopenia will show beneficial
Study of Hsp90 Inhibitor, STA-9090 for Relapsed or Refractory Small Cell Lung Cancer [Active, not 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.
Effect of Consuming Food Cooked in Iron Utensils on Iron Status in Children With Iron Deficiency Anemia (IDA) [Completed]
Iron deficiency is a common problem in the world and more so in the developing countries
with a prevalence of 64 % (using WHO cut-off values of Hb <11. 0 g/dl) among children, 9-36
months of age. The Pediatric population is especially vulnerable to iron deficiency anemia
due to low intake of iron rich foods, rapid growth with high demand and losses of iron from
body especially with the commonly found worm infestations in children. Mild to moderate iron
deficiency is widely prevalent in children and can have several implications including
failure to thrive, poor scholastic performance, repeated infections etc. Dietary measures
along with therapeutic measures are recommended to combat Iron Deficiency Anemia (IDA).
However, iron rich foods alone cannot be relied upon as a sole step to counter IDA. The
utensil in which the food is cooked plays a major role in determining the final iron content
of food. Several studies have documented that most of the foods (90%) contained
significantly more iron when cooked in iron utensils depending on the acidity, moisture
content, and cooking time of food. The daily dietary intake could vary from 11 to 6 mg of
iron if iron utensil was used for cooking .
Food cooked in Aluminum (Al) utensils has a higher Al content which can be detrimental to
healthy individuals and particularly to patients with chronic renal failure. In healthy
persons, diseases of central nervous system, as well as of hematopoeitic system, skeletal
system and respiratory system are described due to excess of Aluminium consumption.
Aluminium utensils have fast replaced iron cooking pots from Indian kitchens, hence a study
to know the effectiveness of iron cooking pot as a measure to combat IDA is necessary.
Studies have shown the utility of cooking food in iron utensil in prevention of IDA but the
investigators did not come across a study to document the use of this modality in treatment
of IDA in children. Since the investigators anticipate that the improvement of iron status
will be a gradual process, so the investigators decided to evaluate the utility of cooking
food in iron utensils on iron status in children with non-severe IDA (Hb% < cutoff point for
age but > 5 gm %.
To test the following hypothesis "use of iron utensils for cooking food will result in
improvement in iron status in Pediatric patients with nonsevere Iron Deficiency Anemia."
Exercise Training in a Geriatric Hospital Ward [Not yet recruiting]
Page last updated: 2006-01-31