Nortrel 7 / 7 / 7 (Norethindrone / Ethinyl Estradiol / Norethindrone / Ethinyl Estradiol / Norethindrone / Ethinyl Estradiol) - Summary

SUMMARY

Nortrel™ 7/7/7
(norethindrone and ethinyl estradiol tablets, USP
0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg)

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

COMBINATION ORAL CONTRACEPTIVES:

Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol:

Nortrel™ 7/7/7 (norethindrone and ethinyl estradiol tablets, USP 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) (21 Day Regimen and 28 Day Regimen): Each light yellow tablet contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol and the inactive ingredients include D&C yellow #10, lactose monohydrate, magnesium stearate and pregelatinized starch. Each blue tablet contains 0.75 mg of norethindrone and 0.035 mg of ethinyl estradiol and the inactive ingredients include FD&C blue no. 1 (aluminum lake), lactose monohydrate, magnesium stearate and pregelatinized starch. Each peach tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol and the inactive ingredients include FD&C yellow no. 6 (aluminum lake), lactose monohydrate, magnesium stearate and pregelatinized starch. Each white tablet in the (28) package contains only inert ingredients as follows: lactose monohydrate, magnesium stearate, and pregelatinized starch.

Nortrel™ 7/7/7 (norethindrone and ethinyl estradiol tablets, USP 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) (21 Day Regimen and 28 Day Regimen) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

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NEWS HIGHLIGHTS

Media Articles Related to Nortrel 7 / 7 / 7 (Norethindrone / Estradiol / Norethindrone / Estradiol / Norethindrone / Estradiol)

US funding revamps African contraceptive drive (AFP)
Source: Y! Health News Search RSS Feed [2009.11.18]
AFP - A new 12 million dollar family planning drive launched here Wednesday highlights how Obama administration funding has revamped a contraception drive in Africa and developing states, UN officials said, noting a sharp turnaround from the Bush era.

Terrence Higgins Trust Welcomes Department Of Health Nursing Degree Announcement, UK
Source: HIV / AIDS News From Medical News Today [2009.11.15]
HIV and sexual health charity Terrence Higgins Trust has welcomed the announcement by the Department of Health that all new nurses will be educated to degree level from 2013. Terrence Higgins Trust (THT) currently employs nurses who work in Chlamydia screening programmes for young people, HIV testing clinics and clinics that offer contraception services and screening for sexually transmitted infections.

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Published Studies Related to Nortrel 7 / 7 / 7 (Norethindrone / Estradiol / 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.

HT update: spotlight on estradiol/norethindrone acetate combination therapy. [2008]
Abstract: The goal ofpostmenopausal hormone therapy is to alleviate the symptoms that are associated with the loss of estrogen. Many formulations of estrogen and progestin are available, depending on the needs and circumstances of each individual woman... The purpose of this review is to describe the risks and benefits of hormonal therapy, focusing on estradiol/norethindrone acetate combination therapy.

A multicenter, open-label study to evaluate satisfaction and menopausal quality of life in women using transdermal estradiol/norethindrone acetate therapy for the management of menopausal signs and symptoms. [2005]
AIM: This multicenter, open-label, single-arm study evaluated subject satisfaction and improvements in menopausal quality of life among menopausal women using the CombiPatch transdermal system consisting of 17beta-estradiol 0.05 mg plus norethindrone acetate 0.14 mg in a matrix patch formulation... CONCLUSIONS: The results of this study compare favorably with previous placebo-controlled studies of transdermal hormone therapy in managing menopausal signs and symptoms. Furthermore, quality of life was significantly improved by the transdermal hormone therapy system, and both subjects and physicians reported high levels of satisfaction. Copyright 2005 S. Karger AG, Basel

Pharmacokinetic interaction between nevirapine and ethinyl estradiol/norethindrone when administered concurrently to HIV-infected women. [2002.04.15]
OBJECTIVE: To determine the effects of nevirapine (NVP), a nonnucleoside reverse-transcriptase inhibitor of HIV-1 and P450 inducer, on the pharmacokinetics (PK) of ethinyl estradiol (EE)/norethindrone (NET), a widely used oral contraceptive, and to assess the effects of EE/NET on the steady-state PK of NVP... CONCLUSION: Oral contraceptives should not be the primary method of birth control in women of child-bearing potential who are treated with NVP.

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Clinical Trials Related to Nortrel 7 / 7 / 7 (Norethindrone / Estradiol / Norethindrone / Estradiol / 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 scores.

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.

Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women [Recruiting]
The goal of this three-armed randomized controlled trial is to establish the relative roles of treatment of hyperandrogenism versus obesity (as the largest modifiable factor contributing to insulin resistance) in treating infertility and improving pregnancy outcomes among obese PCOS women. The investigators hypothesize that the key to restoring ovulation leading to live birth is to correct hyperandrogenism with oral contraceptive pills, but the key to avoiding later pregnancy complications is to improve insulin sensitivity with weight loss.

Drug Interactions Between Lopinavir/Ritonavir and Oral or Patch Contraceptives in HIV Infected Women [Active, not recruiting]
The purpose of this study is to examine the drug interactions between a protease inhibitor (PI)-based regimen including lopinavir/ritonavir (LPV/r) and two forms of contraceptive medications in HIV infected women.

A Study of the Effects of GSK189075 on PK Profiles of an Oral Contraceptive Pill When Given to Healthy Female Volunteers [Active, not recruiting]

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