Brevicon ® Tablets provide a continuous oral contraceptive regimen consisting of 21 blue tablets containing norethindrone 0.5 mg and ethinyl estradiol 0.035 mg and 7 orange tablets containing inert ingredients.
Norinyl ® 1+35 Tablets provide a continuous oral contraceptive regimen consisting of 21 yellow-green tablets containing norethindrone 1 mg and ethinyl estradiol 0.035 mg and 7 orange tablets containing inert ingredients.
Norinyl ® 1+50 Tablets provide a continuous oral contraceptive regimen consisting of 21 white tablets containing norethindrone 1 mg and mestranol 0.05 mg and 7 orange tablets containing 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. Mestranol is an estrogen with the chemical name 3-Methoxy-19-nor-17α-pregna-1,3,5(10)-trien-20-yn-17-ol.
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 1+50, which contain 50 mcg of estrogen, should not be used unless medically indicated.
Media Articles Related to Brevicon (Norethindrone / Estradiol)
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
Plan B: Obama Administration to Drop Age Limits on OTC Sales
Source: MedPage Today OB/Gyn [2013.06.10]
WASHINGTON (MedPage Today) -- The Obama administration signaled its intent late Monday to stand down in the emergency contraception fray, announcing that it was dropping plans to appeal a Federal judge's decision to allow broad access to Plan B One-Step.
Published Studies Related to Brevicon (Norethindrone / Estradiol)
Effect of the bile acid sequestrant colesevelam on the pharmacokinetics of pioglitazone, repaglinide, estrogen estradiol, norethindrone, levothyroxine, and glyburide. [2010.05]
The purpose of this study was to assess effects of colesevelam on the pharmacokinetics of glyburide, levothyroxine, estrogen estradiol (EE), norethindrone (NET), pioglitazone, and repaglinide in healthy volunteers. Six drugs with a potential to interact with colesevelam were studied in open-label, randomized clinical studies.
Does hormone therapy improve age-related skin changes in postmenopausal women? A randomized, double-blind, double-dummy, placebo-controlled multicenter study assessing the effects of norethindrone acetate and ethinyl estradiol in the improvement of mild to moderate age-related skin changes in postmenopausal women. [2008.09]
BACKGROUND: In postmenopausal women, declining estrogen levels are associated with a variety of skin changes, many of which are reportedly improved by estrogen supplementation. OBJECTIVE: A study was conducted to assess the effects of continuous combined norethindrone acetate (NA) and ethinyl estradiol (EE) in the control of mild to moderate age-related skin changes in postmenopausal women... CONCLUSION: Low-dose hormone therapy for 48 weeks in postmenopausal women did not significantly alter mild to moderate age-related facial skin changes.
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.
Impact of combined estradiol and norethindrone therapy on visuospatial working memory assessed by functional magnetic resonance imaging. [2006.11]
CONTEXT: Hormones regulate neuronal function in brain regions critical to cognition; however, the cognitive effects of postmenopausal hormone therapy are controversial. OBJECTIVE: The goal was to evaluate the effect of postmenopausal hormone therapy on neural circuitry involved in spatial working memory... CONCLUSIONS: Hormone therapy was associated with more effective activation of a brain region critical in primary visual working memory tasks. The data suggest a functional plasticity of memory systems in older women that can be altered by hormones.
Effects of low-dose norethindrone acetate plus ethinyl estradiol (0.5 mg/2.5 microg) in women with postmenopausal symptoms: updated analysis of three randomized, controlled trials. [2006.06]
BACKGROUND: Based on the potential risks of post-menopausal hormone therapy (HT) found by the Women's Health Initiative, guidelines for HT now recommend use of the lowest effective dose and shortest treatment duration consistent with individual treatment goals. Current (2003) guidance established by the US Food and Drug Administration (FDA) recommends that clinical assessments of HT include women with more frequent and more intense vasomotor symptoms than previously studied. Therefore, this analysis was conducted to further assess the efficacy of a low-dose combination of norethindrone acetate and ethinyl estradiol (NA/EE) previously assessed in dose-ranging studies, while meeting conservative FDA trial design and analysis criteria. OBJECTIVES: The aim of this post hoc analysis and overview was to present data on the efficacy and tolerability of a low-dose combination-NA/EE 0.5 mg/2.5 microg-in the treatment of postmenopausal symptoms, based on data from previously published studies of NA/EE. In addition, the effects of low-dose NA/EE on bone and endometrium are briefly reviewed... CONCLUSIONS: The results from this post hoc analysis and overview of 3 previously published studies suggest that NA/EE 0.5 mg/2.5 microg was associated with decreased frequency and intensity of vasomotor symptoms. This dose of NA/EE was also associated with maintenance of BMD over 24 months, a significant positive effect on BMD compared with placebo. Low-dose NA/EE was also associated with cumulative amenorrhea rates comparable to those of placebo and was not associated with endometrial hyperplasia. This dose was well tolerated, with rates of adverse events generally similar to those of placebo.
Clinical Trials Related to Brevicon (Norethindrone / Estradiol)
Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills) [Active, not recruiting]
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 satisfaction
A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen [Recruiting]
The purpose of this study is to investigate the effect of steady-state concentrations of
TMC435 (administered once a day) on the steady-state pharmacokinetics of ethinylestradiol
and norethindrone (administered once a day) and on the levels of progesterone, luteinizing
hormone and follicle-stimulating hormone, in healthy female participants. Ethinlyestradiol
and norethindrone are synthetic hormones, which constitute the oral contraceptive Ovysmen.
Also the short-term safety and tolerability of the co-administration of TMC435 and Ovysmen
will be studied. Steady-state is a term that means that the drug has been given long enough
so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is
being investigated for the treatment of chronic hepatitis C virus (HCV) infection.
Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in
the body and eliminated from the body. A contraceptive is a method that prevents pregnancy.
Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation [Recruiting]
The purpose of this research study is to gain a better understanding of the changes that may
occur in the breast when a woman uses an oral contraceptive (birth control pill). Some
research indicates that women who use birth control pills with lower amounts of estrogen (a
hormone in the birth control pill) may have lower breast cell growth than women who use
birth control pills with a higher amount of estrogen; this research will examine that in
detail. This research will also test whether the results found in HS-07-00269 can be
TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women. [Recruiting]
The purpose of this study is to investigate the pharmacokinetic interaction between the
combination of ethinylestradiol and norethindrone and TMC278 25 mg once daily.
Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body
and eliminated from the body. Furthermore the short-term safety and tolerability (how well
the body tolerates the drug) of co-administration of TMC278 and ethinylestradiol and
norethindrone, in healthy women, will be assessed.
Randomized Trial of Induction Therapies in High Immunological Risk Kidney Transplant Recipients [Recruiting]
The purpose of this research study is to find out the effects of adding B lymphocyte
modulating agents in patients at risk for rejection receiving an anti-rejection
(immunosuppressive) regimen of Thymoglobulin® induction with Prograf®, Cellcept® and