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Ortho-Novum (Norethindrone / Mestranol) - 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.

 

ORTHO-NOVUM SUMMARY

ORTHO-NOVUM ® Tablets
(norethindrone/ethinyl estradiol)
and MODICON ® Tablets
(norethindrone/ethinyl estradiol)

The following product is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound mestranol: ORTHO-NOVUM® 1/50: Each yellow tablet contains 1 mg of norethindrone and 0.05 mg of mestranol.

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptive products such as ORTHO-NOVUM 1/50, which contains 50 mcg of estrogen, should not be used unless medically indicated.


See all Ortho-Novum indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ortho-Novum (Norethindrone / Mestranol)

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.
Medscape Ob/Gyn

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...

more news >>

Published Studies Related to Ortho-Novum (Norethindrone / Mestranol)

Effect of topiramate or carbamazepine on the pharmacokinetics of an oral contraceptive containing norethindrone and ethinyl estradiol in healthy obese and nonobese female subjects. [2003.04]
PURPOSE: To study the pharmacokinetics of a combination oral contraceptive (OC) containing norethindrone and ethinyl estradiol during OC monotherapy, concomitant OC and topiramate (TPM) therapy, and concomitant OC and carbamazepine (CBZ) therapy in order to comparatively evaluate the pharmacokinetic interaction, which may cause contraceptive failure... CONCLUSIONS: TPM, at daily doses of 50-200 mg, does not interact with an OC containing norethindrone and ethinyl estradiol. The lack of the TPM-OC interaction is notable when it is compared with the CBZ-OC interaction.

Efficacy, cycle control, and safety of two triphasic oral contraceptives: Cyclessa (desogestrel/ethinyl estradiol) and ortho-Novum 7/7/7 (norethindrone/ethinyl estradiol): a randomized clinical trial. [2000.05]
The contraceptive efficacy, cycle control, and safety of a new low-dose, triphasic desogestrel/ethinyl estradiol oral contraceptive (CTR 77, Cyclessa(TM)) was compared to that of a marketed, triphasic norethindrone/ethinyl estradiol oral contraceptive (Ortho-Novum(R) 7/7/7).Cyclessa provides significantly improved cycle control with no weight gain.

A multicenter randomized comparison of cycle control and laboratory findings with oral contraceptive agents containing 100 microg levonorgestrel with 20 microg ethinyl estradiol or triphasic norethindrone with ethinyl estradiol. [1999.11]
OBJECTIVE: This study was undertaken to compare the effects of 2 oral contraceptive regimens on menstrual cycle control and laboratory findings... CONCLUSIONS: Levonorgestrel (100 microg) with ethinyl estradiol (20 microg) provides menstrual cycle control equivalent to that obtained with triphasic norethindrone with ethinyl estradiol (75% higher estrogen dose) with similar safety and tolerability.

Effects of rifabutin and rifampicin on the pharmacokinetics of ethinylestradiol and norethindrone. [1998.11]
This open-label, randomized, three-way crossover study of 28 healthy premenopausal women was conducted to compare the impact of concomitant rifabutin and rifampicin on the safety, pharmacokinetics, and pharmacodynamics of the oral contraceptives ethinylestradiol and norethindrone (Ortho-Novum 1/35; Ortho Pharmaceutical, Raritan, NJ)...

Bioequivalence of two oral contraceptive drugs containing norethindrone and ethinyl estradiol. [1989.11]
Two oral contraceptive drugs, Formulation A and Formulation B, both of similar hormonal content, were compared with each other to determine if they were bioequivalent... The data support the hypothesis for bioequivalence of the two formulations with respect to total absorption.

more studies >>

Clinical Trials Related to Ortho-Novum (Norethindrone / Mestranol)

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.

A Pharmacokinetics (PK) and Safety Study to Determine the Effect of Repeat Dosing of Trametinib on Combined Oral Contraceptive (Norethindrone Plus Ethinyl Estradiol) in Female Subjects With Solid Tumors [Not yet recruiting]
This is a Phase I, open-label, non-randomized, sequential, two-period, repeat-dose study to evaluate the effect of trametinib 2 milligram (mg) once daily on the repeat-dose pharmacokinetic (PK) of an oral contraceptive (OC) containing norethindrone (NE) and ethinyl estradiol (EE) (ORTHO-NOVUM® tablets: 1 mg NE + 0. 035 mg EE) in female subjects with solid tumors. The study will determine PK interaction between trametinib and the components of combination oral contraceptives that would compromise the effectiveness of the contraceptives. The study will also evaluate the repeat dose PK of trametinib and its metabolite M5 using a validated assay. The study will enroll approximately 24 subjects. Each subject will participate in the study for approximately up to 13 to 15 weeks which will consist of a 30 day screening period, followed by 2 treatment periods (Period 1: 28 days and Period 2: ranging from 12 days to up to 21 days), and a transition visit or post-treatment follow-up visit. In Period 1, subjects will take one active tablet from the ORTHO-NOVUMĀ® tablet 1/35 dial-pack once daily at approximately the same time each day for 21 days (Days 1 through 21), followed by one inert (referred to as placebo) tablet once daily at approximately the same time each day for 7 days (Days 22 through 28). In addition, subjects will take trametinib 2 mg (1 tablet) once daily at approximately the same time each day for a total of 17 days (Days 12 through 28). In Period 2, subjects will take one active tablet from the ORTHO-NOVUMĀ® tablet 1/35 dial-pack once daily at approximately the same time each day for 11 days (Days 1 through 11). In addition, subjects will continue taking trametinib 2 mg (1 tablet) once daily at approximately the same time each day for 11 days (Days 1 through 11). ORTHO-NOVUMĀ® is a registered trademark of Ortho Pharmaceutical Corporation.

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.

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 satisfaction scores.

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.

more trials >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Ortho-Novum has an overall score of 7. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Ortho-Novum review by 28 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   birth control
Dosage & duration:   not sure (dosage frequency: daily) for the period of 10 years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   The prevention of pregnancy was the benefit in addition to almost completely eliminating a monthly menstrual cycle. Other than that, there were no other benefits involved in taking this medication. The benefits at the time that I was taking this drug outweighed the risks. However, at this time, the risks and side effects now outweigh the benefits.
Side effects:   After going off of the birth control pill, I noticed an elevation of mood. When I began taking the pill after being off of it for a while, I noticed the difference in my mood. My mood is much more consistently positive when not on the drug. In addition, now that I am older, I have no desire to take this medication as the potential side effects/risks are too high for women who are 30+. The risks that most concern me are risk of blood clots and stroke even though I have never been a smoker.
Comments:   I took the birth control pill for approximately 10 years fairly consistently. There were periods of time during those 10 years when I did not take the drug. I am no longer taking the birth control pill and do not currently see this as a viable option for me given my age and potential side effects.

 

Ortho-Novum review by 28 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   birth control
Dosage & duration:   not sure (dosage frequency: daily) for the period of 10 + years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   The only treatmenet benefits were the prevention of pregnancy and the near elimination of a monthly menstrual cycle --including the elimination of painful cramping during the monthly cyle. The benefits at the time I was taking this medication outweighed the risks/side effects, but now the risks/side effects outweigh the benefits.
Side effects:   The main side effect was moodiness/mood swings. I did not notice this so much while taking the medication. I noticed the moodiness/mood swings more after being off of the medication for an extended period of time. After being off of the medication I noticed a more stabe, hightened mood.
Comments:   The treatment continued off and on for approximately 10 years. During this time, I did go off of the medication for short intervals just due to the lack of necessity for the drug. The medication was taken on a daily basis, and was effective. Now, however, for me--the health risks involved in taking the drug (risk of heart attack, stroke, blood clots) far outweigh the benefits (I am a non smoker). In addition, the mood factor also played a part in not returning to taking this drug.

See all Ortho-Novum reviews / ratings >>

Page last updated: 2015-08-28

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