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Estrostep Fe (Norethindrone Acetate / Ethinyl Estradiol / Norethindrone Acetate / Ethinyl Estradiol / Norethindrone Acetate / Ethinyl Estradiol) - Summary

 
 



BOX WARNING

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

ESTROSTEPFe
(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.


See all Estrostep Fe indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Estrostep Fe (Norethindrone / Estradiol / Norethindrone / Estradiol / Norethindrone / Estradiol)

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.

New study finds that the probability of unprotected intercourse in hookups doubles between freshman
Source: Sexual Health / STDs News From Medical News Today [2014.10.20]
An article released by Social Forces titled, "Casual Contraception in Casual Sex: Life-Cycle Change in Undergraduates' Sexual Behavior in Hookups" by Jonathan Marc Bearak (New York University)...

Free birth control reduces teen pregnancies and abortions
Source: Abortion News From Medical News Today [2014.10.03]
Teens who received free contraception and were educated about the pros and cons of various birth control methods were dramatically less likely to get pregnant, give birth or get an abortion compared...

more news >>

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. [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 Estrostep Fe (Norethindrone / Estradiol / Norethindrone / Estradiol / Norethindrone / Estradiol)

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 confirmed.

Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448) [Recruiting]
The purpose of this study is to assess the contraceptive efficacy of a nomegestrol acetate + 17-estradiol (NOMAC-E2) combined oral contraceptive (COC) in healthy, sexually-active American women at risk for pregnancy. Vaginal bleeding patterns of women taking NOMAC-E2 will be assessed and compared to those of women taking a norethisterone acetate + ethinyl estradiol (NETA-EE) COC. The safety of NOMAC-E2 will also be assessed.

Participants will be randomized to receive either NOMAC-E2 or NETA-EE in a 3: 1 ratio.

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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

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   contraceptive
Dosage & duration:   not sure (dosage frequency: daily) for the period of 8 years
Other conditions:   no conditions
Other drugs taken:   none
  
Reported Results
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

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
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
  
Reported Results
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

See all Estrostep FE reviews / ratings >>

Page last updated: 2014-10-20

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