(Norethindrone and Ethinyl Estradiol Tablets USP)
Tri-Norinyl ® provides a continuous oral contraceptive regimen of 7 blue tablets, 9 yellow-green tablets, 5 more blue tablets, and then 7 orange tablets. Each blue tablet contains norethindrone 0.5 mg and ethinyl estradiol 0.035 mg, each 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 Tri-Norinyl (Norethindrone / Estradiol / Norethindrone / Estradiol)
LARC versus SARC: Major study demonstrates clear benefits of long-acting reversible contraception compared to short-acting reversible contraception
Source: Sexual Health / STDs News From Medical News Today [2016.09.22]
Benefits of increased voluntary uptake of LARC may extend to wider populations than previously thought, according to a major study in the American Journal of Obstetrics and Gynecology.
LARC Study: More Consistent Use, Lower Pregnancy Rate
Source: MedPage Today OB/Gyn [2016.09.22]
(MedPage Today) -- Advantages of long-acting reversible contraception affirmed
Published Studies Related to Tri-Norinyl (Norethindrone / Estradiol / Norethindrone / Estradiol)
Combined continuous ethinyl estradiol/norethindrone acetate does not improve forearm blood flow in postmenopausal women at risk for cardiovascular events: a pilot study. [2007.09]
OBJECTIVE: This study sought to determine whether combined continuous ethinyl estradiol and norethindrone acetate, a postmenopausal hormone therapy (HT) combination designed to have fewer side effects than cyclical therapies and therapies using medroxyprogesterone acetate (MPA), could improve vascular endothelial function in postmenopausal women with risk factors for cardiovascular disease (CVD)... CONCLUSIONS: In this older postmenopausal population with at least one cardiovascular risk factor, treatment with combined continuous ethinyl estradiol and norethindrone acetate failed to improve vascular endothelial function. The agent's proinflammatory effect or subclinical atherosclerosis in this population may have contributed to this finding.
Cycle control, tolerability, and satisfaction among women switching from 30-35 microg ethinyl estradiol-containing oral contraceptives to the triphasic norgestimate/25 microg ethinyl estradiol-containing oral contraceptive Ortho Tri-Cyclen LO. [2003.07]
OBJECTIVE: To determine cycle control, tolerability, and satisfaction among women (aged 18-45) switching from oral contraceptives (OCs) containing 30-35 microg ethinyl estradiol (EE) to Ortho Tri-Cyclen LO (norgestimate 180/215/250 microg/EE 25 microg) and Loestrin Fe 1/20 (norethindrone acetate 1 mg/EE 20 microg)...
Comparison of a novel norgestimate/ethinyl estradiol oral contraceptive (Ortho Tri-Cyclen Lo) with the oral contraceptive Loestrin Fe 1/20. [2001.06]
This multicenter study compared the contraceptive efficacy, cycle control, and safety of a new triphasic norgestimate (180/215/250 microg)/ethinyl estradiol 25 microg regimen (Ortho Tri-Cyclen Lo) (n = 1,723) with that of norethindrone acetate 1 mg/ethinyl estradiol 20 microg (Loestrin Fe 1/20) (n = 1,171)...
Comparative clinical evaluation of the effect on carbohydrate and lipid metabolism of two norethisterone-containing hormonal contraceptives: Mesigyna and TriNovum. [1997.05]
The effect on carbohydrate and lipid metabolism of two hormonal contraceptive preparations containing norethisterone (commercially known as Mesigyna and TriNovum) was studied in a total of 60 women, before and after 6 months of treatment. Carbohydrate metabolism was evaluated by means of a euglycemic glucose clamp test; lipid metabolism was monitored by measuring total cholesterol, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol, and triglycerides...
A triphasic oral contraceptive pill, CTR-05: clinical efficacy and safety. [1996.09]
CONCLUSION: Desogestrel, with little estrogenic activity and only minimal androgenic activity, leads to lipoprotein changes, resulting in a favorable cardiovascular profile, as well as minimal androgen-related effects, such as hirsutism and acne.
Clinical Trials Related to Tri-Norinyl (Norethindrone / Estradiol / Norethindrone / Estradiol)
Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone [Completed]
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.
Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills) [Completed]
The purpose of this research study is to assess hormone withdrawal symptoms in women while
taking an oral contraceptive in the novel 24/4 (24 days of "real" pills) manner in
comparison to taking pills in the standard 21/7 (21 "real" pills) manner.
It is hypothesized that the 24/4 method will reduce common hormone withdrawal symptoms
compared to the standard 21/7 regimen.
It is further hypothesized that women using the 24/4 regimen will report greater
Gender Disparity and Hormones in Cystic Fibrosis [Recruiting]
The objective of this study is to investigate the impact of hormones on lung disease in
Cystic Fibrosis (CF) patients. Due to improved therapies, CF patients are living longer and
healthier lives than they did 20 years ago. However, females have been shown to have a
survival disadvantage. The median life expectancy is 33 in women and 37 in men with CF. The
hypothesis is that estrogen and/or progesterone negatively impact lung health in CF.
Therefore, understanding the impact of sex hormones (including the use of birth control
pills) on the disease process is increasingly important. The purpose of this study is to
determine if lung function, respiratory symptoms, or various markers of lung health change
during different phases of the natural ovulatory cycle in order to understand if estrogen or
progesterone hormones are impacting the disease relative to fluctuations in men with stable
testosterone levels. The research objectives of this project are to:
- Determine if lung function, respiratory symptoms, or various markers of lung health
change during different hormonal phases of the ovulatory cycle in women.
- Determine if men change lung function, respiratory symptoms, or various markers of lung
health over time.
- Determine if oral contraceptive pills in women stabilize fluctuations in symptoms and
improve lung health.
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions [Completed]
The purpose of this study was to evaluate the relative bioavailability of a test formulation
of norethindrone/ethinyl estradiol 0. 4 mg/0. 035 mg chewable tablets (Teva Pharmaceuticals,
USA) compared to the reference listed product, FEMCON® Fe (norethindrone/ethinyl estradiol
and ferrous fumarate) 0. 4 mg/0. 035 mg Chewable tablets (Warner Chilcott) under fed
conditions in healthy, non-tobacco using, adult female subjects.
A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis [Completed]
This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on
the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female
patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child
bearing age. The RA patients received OC in combination with TCZ, whereas the healthy
volunteers received OC only. The RA patients received OC in 3 cycles of 21 days each; TCZ 8
mg/kg was administered once as an intravenous infusion on the first day of Cycle 2. The
healthy volunteers received OC for only one 21-day cycle.