Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
ESTROSTEP FE SUMMARY
(Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*)
ESTROSTEP® Fe is a graduated estrophasic oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. ESTROSTEP Fe provides for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white triangle-shaped tablet contains 1 mg norethindrone acetate [(17 alpha)-17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17 alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol]; each white square-shaped tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each white round tablet contains 1 mg norethindrone acetate and 35 mcg ethinyl estradiol. Each tablet also contains calcium stearate; lactose; microcrystalline cellulose; and starch.
ESTROSTEP Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
ESTROSTEP Fe is indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. ESTROSTEP Fe should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least 6 months.
Published Studies Related to Estrostep Fe (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 Estrostep Fe (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.
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 2 ratings/reviews, Estrostep FE has an overall score of 9. The effectiveness score is 10 and the side effect score is 9. The scores are on ten point scale: 10 - best, 1 - worst.
Estrostep FE review by 29 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || contraceptive|
|Dosage & duration:|| || not sure (dosage frequency: daily) for the period of 8 years|
|Other conditions:|| || no conditions|
|Other drugs taken:|| || none|
|Benefits:|| || this drug claims 99.9% accuracy when administered daily with very little side effects, have been using for several years with no weight gain and no accidents. the packaging is simple, easy and convenient.|
|Side effects:|| || no side effects that i could recognize, pretty common.|
|Comments:|| || dosage is a daily administration, not complex. pretty convenient.|
Estrostep FE review by 27 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || oral contraceptive|
|Dosage & duration:|| || 1 pill a day taken everyday for the period of 4 years|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || this birth control pills helps your skin if u are someone who breaks out often |
|Side effects:|| || none really but i have increased pms symptoms around 2 weeks beforre my period etc.. certain food cravings, fatigue, muscle weakness. also lost weight from this pill as it suppresses my appetite|
|Comments:|| || one pill a day preferably at the same time every day|
Page last updated: 2008-08-10