Application Nr Approved Date Route Status External Links
NDA020130 1996-10-09 None DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage 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. Oral Contraceptives Are Highly Effective For Pregnancy Prevention. Table 2 Lists The Typical Accidental Pregnancy Rates For Users Of Combination Oral Contraceptives And Other Methods Of Contraception. The Efficacy Of These Contraceptive Methods, Except Sterilization, Depends Upon The Reliability With Which They Are Used. Correct And Consistent Use Of Methods Can Result In Lower Failure Rates. Table 2. Percentage Of Women Experiencing An Unintended Pregnancy During The First Year Of Typical Use And The First Year Of Perfect Use Of Contraception And The Percentage Continuing Use At The End Of The First Year. United States. % Of Women Experiencing An Unintended Pregnancy Within The First Year Of Use % Of Women Continuing Use At One Yearamong Couples Attempting To Avoid Pregnancy, The Percentage Who Continue To Use A Method For 1 Year. Method Typical Useamong Typical Couples Who Initiate Use Of A Method (not Necessarily For The First Time), The Percentage Who Experience An Accidental Pregnancy During The First Year If They Do Not Stop Use For Any Other Reason. Perfect Useamong Couples Who Initiate Use Of A Method (not Necessarily For The First Time) And Who Use It Perfectly (both Consistently And Correctly), The Percentage Who Experience An Accidental Pregnancy During The First Year If They Do Not Stop Use For Any Other Reason. (1) (2) (3) (4) Chancethe Percentages Becoming Pregnant In Columns (2) And (3) Are Based On Data From Populations Where Contraception Is Not Used And From Women Who Cease Using Contraception In Order To Become Pregnant. Among Such Populations, About 89% Become Pregnant Within One Year. This Estimate Was Lowered Slightly (to 85%) To Represent The Percent Who Would Become Pregnant Within One Year Among Women Now Relying On Reversible Methods Of Contraception If They Abandoned Contraception Altogether. 85 85 Spermicidesfoams, Creams, Gels, Vaginal Suppositories, And Vaginal Film. 26 6 40 Periodic Abstinence 25 63 Calendar 9 Ovulation Method 3 Symptothermalcervical Mucus (ovulation) Method Supplemented By Calendar In The Pre-Ovulatory And Basal Body Temperature In The Post-Ovulatory Phases. 2 Post-Ovulation 1 Capwith Spermicidal Cream Or Jelly. Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 20 6 56 Withdrawal 19 4 Condomwithout Spermicides. Female (reality) 21 5 56 Male 14 3 61 Pill 5 71 Progestin Only 0.5 Combined 0.1 Iud Progesterone T 2.0 1.5 81 Copper T380a 0.8 0.6 78 Lng 20 0.1 0.1 81 Depo-Provera® 0.3 0.3 70 Norplant® And Norplant-2® 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Emergency Contraceptives Pills: Treatment Initiated Within 72 Hours After Unprotected Intercourse Reduces The Risk Of Pregnancy By At Least 75%.the Treatment Schedule Is One Dose Within 72 Hours After Unprotected Intercourse, And A Second Dose 12 Hours After The First Dose. The Food And Drug Administration Has Declared The Following Brands Of Oral Contraceptives To Be Safe And Effective For Emergency Contraception: Ovral® (1 Dose Is 2 White Pills), Alesse® (1 Dose Is 5 Pink Pills), Nordette® Or Levlen® (1 Dose Is 4 Light-Orange Pills), Lo/ovral® (1 Dose Is 4 White Pills), Triphasil® Or Tri-Levlen® (1 Dose Is 4 Yellow Pills). Lactational Amenorrhea Method: Lam Is A Highly Effective, Temporary Method Of Contraception.however, To Maintain Effective Protection Against Pregnancy, Another Method Of Contraception Must Be Used As Soon As Menstruation Resumes, The Frequency Or Duration Of Breastfeeds Is Reduced, Bottle Feeds Are Introduced, Or The Baby Reaches 6 Months Of Age. Source: Trussell J, The Essentials Of Contraception. In Hatcher Ra, Trussell J, Stewart F, Cates W, Stewart Gk, Kowel D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York Ny: Irvington Publishers, 1998. Estrostep Fe Was Evaluated For The Treatment Of Acne Vulgaris In Two Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3, Six (28-Day) Cycle Studies. A Total Of 296 Patients Received Estrostep Fe And 295 Received Placebo. Mean Age At Enrollment For Both Groups Was 24 Years. At Six Months Each Study Demonstrated A Statistically Significant Difference Between Estrostep Fe And Placebo For Mean Change From Baseline In Lesion Counts (see Table 3 And Figure 2). Each Study Also Demonstrated Overall Treatment Success In The Investigator’s Global Evaluation. Patients With Severe Androgen Excess Were Not Studied. Table 3. Acne Vulgaris Indication Pooled Data 376-403 And 376-404 Observed At Six Months And At Baselinenumbers Rounded To Nearest Integer Intent To Treat Population Estrostep Fen = 296 Placebon = 295 Difference In Counts Between Estrostep Fe And Placebo At Six Months (95% Ci)limits For 95% Confidence Interval; Not Adjusted For Baseline Differences Number Of Lesions Counts % Reduction Counts % Reduction Inflammatory Lesions Baseline Mean 29 29 Six Month Mean 14 52% 17 41% 3 (±2) Non-Inflammatory Lesions Baseline Mean 44 43 Six Month Mean 27 38% 32 25% 5 (±3.5) Total Lesions Baseline Mean 74 72 Six Month Mean 42 43% 49 32% 7 (±5) Estrostep Fe Users Who Started With About 74 Acne Lesions Had About 42 Lesions After 6 Months Of Treatment. Placebo Users Who Started With About 72 Acne Lesions Had About 49 Lesions After The Same Duration Of Treatment. Figure 2. Mean Percent Reduction In Total Lesion Counts From Baseline To Each 28-Day Cycle And Mean Total Lesion Counts At Each Cycle Following Administration Of Estrostep Fe And Placebo (statistically Significant Differences Were Not Found In Both Studies Individually Until Cycle 6) Graph Showing Mean Percent Reduction In Total Lesion Counts From Baseline To Each 28-Day Cycle And Mean Total Lesion Counts At Each Cycle Following Administration Of Estrostep Fe And Placebo (statistically Significant Differences Were Not Found In Both Studies Individually Until Cycle 6)

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