(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.
Media Articles Related to Nortrel 7 / 7 / 7 (Norethindrone / Estradiol / Norethindrone / Estradiol / Norethindrone / Estradiol)
Teens and Women Aged 35+ Least Likely to Use Contraception
Source: Medscape Headlines [2015.08.28]
Dr Peter Kovacs says that a new analysis of factors associated with nonuse of contraception can be used to identify women at risk for unplanned pregnancy.
Domestic violence deters contraception
Source: Abortion News From Medical News Today [2015.04.02]
Domestic violence takes many forms. The control of a woman's reproductive choices by her partner is one of them.
'15 million unwanted pregnancies' created by low contraception in 35 poorer countries
Source: Abortion News From Medical News Today [2015.02.05]
Some 90% of the 16.7 million unwanted pregnancies across a third of the world's population every year are due to a failure to use modern contraception, study suggests.
Research reveals more than half of young women who have abortions were using contraception when they fell pregnant
Source: Abortion News From Medical News Today [2014.04.30]
Reproductive health charity Marie Stopes UK has launched the findings of the first research in the UK into the contraceptive use of women aged 16-24 having one or more abortions.
Female cystic fibrosis patients need more contraceptive guidance, study finds
Source: Cystic Fibrosis News From Medical News Today [2015.05.11]
As life span for once-deadly disease increases, unplanned and mistimed pregnancies are commonOnly half of women with cystic fibrosis (CF) report using contraception and frequently apt to become...
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. 
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. 
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.
Clinical Trials Related to Nortrel 7 / 7 / 7 (Norethindrone / Estradiol / 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.