Ortho-Novum (Norethindrone / Mestranol) - Summary

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.

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NEWS HIGHLIGHTS

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

US funding revamps African contraceptive drive (AFP)
Source: Y! Health News Search RSS Feed [2009.11.18]
AFP - A new 12 million dollar family planning drive launched here Wednesday highlights how Obama administration funding has revamped a contraception drive in Africa and developing states, UN officials said, noting a sharp turnaround from the Bush era.

Terrence Higgins Trust Welcomes Department Of Health Nursing Degree Announcement, UK
Source: HIV / AIDS News From Medical News Today [2009.11.15]
HIV and sexual health charity Terrence Higgins Trust has welcomed the announcement by the Department of Health that all new nurses will be educated to degree level from 2013. Terrence Higgins Trust (THT) currently employs nurses who work in Chlamydia screening programmes for young people, HIV testing clinics and clinics that offer contraception services and screening for sexually transmitted infections.

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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.

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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.

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.

Drug Interactions Between Lopinavir/Ritonavir and Oral or Patch Contraceptives in HIV Infected Women [Active, not recruiting]
The purpose of this study is to examine the drug interactions between a protease inhibitor (PI)-based regimen including lopinavir/ritonavir (LPV/r) and two forms of contraceptive medications in HIV infected women.

Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women [Recruiting]
The goal of this three-armed randomized controlled trial is to establish the relative roles of treatment of hyperandrogenism versus obesity (as the largest modifiable factor contributing to insulin resistance) in treating infertility and improving pregnancy outcomes among obese PCOS women. The investigators hypothesize that the key to restoring ovulation leading to live birth is to correct hyperandrogenism with oral contraceptive pills, but the key to avoiding later pregnancy complications is to improve insulin sensitivity with weight loss.

Safety of Estrogens in Lupus: Birth Control Pills [Completed]

Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test

whether women with systemic lupus erythematosus (SLE or lupus) can safely use estrogen. We will determine this by looking at the effects of oral contraceptives (birth control pills, also known as "the pill") on disease activity and severity in women with SLE. The results of the study will show whether it is safe for women with SLE to use the pill.

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