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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)

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 research shows a statistical significant association between increased LARC usage and reduction in teenage pregnancy and abortion rates in England
Source: Abortion News From Medical News Today [2014.11.27]
New findings, published in the International Journal of Women's Health, show increased long-acting reversible contraception (LARC) usage in England was significantly associated with decreased...

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 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)

Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills) [Active, not recruiting]
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.

A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen [Recruiting]
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 (administered once a day) on the steady-state pharmacokinetics of ethinylestradiol and norethindrone (administered once a day) and on the levels of progesterone, luteinizing hormone and follicle-stimulating hormone, in healthy female participants. Ethinlyestradiol and norethindrone are synthetic hormones, which constitute the oral contraceptive Ovysmen. Also the short-term safety and tolerability of the co-administration of TMC435 and Ovysmen will be studied. Steady-state is a term that means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. A contraceptive is a method that prevents pregnancy.

TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women. [Recruiting]
The purpose of this study is to investigate the pharmacokinetic interaction between the combination of ethinylestradiol and norethindrone and TMC278 25 mg once daily. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. Furthermore the short-term safety and tolerability (how well the body tolerates the drug) of co-administration of TMC278 and ethinylestradiol and norethindrone, in healthy women, will be assessed.

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.

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: 2014-11-27

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