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Ortho TRI-Cyclen (Norgestimate / 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.

 

SUMMARY

ORTHO TRI-CYCLEN® TABLETS
ORTHO-CYCLEN® TABLETS
(norgestimate/ethinyl estradiol)

Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.

ORTHO-CYCLEN and ORTHO TRI-CYCLEN Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

ORTHO TRI-CYCLEN 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 contraception, have achieved menarche and are unresponsive to topical anti-acne medications.


See all Ortho TRI-Cyclen indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Ortho TRI-Cyclen (Norgestimate / Ethinyl Estradiol)

Effect of raltegravir on estradiol and norgestimate plasma pharmacokinetics following oral contraceptive administration in healthy women. [2011.04]
AIMS: Oral contraceptives such as norgestimate-ethinyl estradiol (Ortho Tri-Cyclen(R)) are commonly prescribed in the HIV-infected patient population. A placebo-controlled, randomized, two-period crossover study in healthy HIV-seronegative subjects was conducted to assess the effect of raltegravir on the pharmacokinetics of the estrogen and progestin components of norgestimate-ethinyl estradiol [ethinyl estradiol (EE) and norelgestromin (NGMN), an active metabolite of norgestimate (NGT)]... CONCLUSIONS: Raltegravir has no clinically important effect on EE or NGMN pharmacokinetics. Co-administration of raltegravir and an oral contraceptive containing EE and NGT was generally well tolerated; no dose adjustment is required for oral contraceptives containing EE and NGT when co-administered with raltegravir. (c) 2011 The Authors. British Journal of Clinical Pharmacology (c) 2011 The British Pharmacological Society.

Effect of laropiprant, a PGD2 receptor 1 antagonist, on estradiol and norgestimate pharmacokinetics after oral contraceptive administration in women. [2009.11]
Laropiprant is a prostaglandin D2 receptor 1 antagonist that is being developed in combination with niacin for the treatment of dyslipidemia. This randomized clinical study evaluated the effect of laropiprant on the pharmacokinetics of ethinyl estradiol (EE) and norelgestromin (NGMN), the principal circulating metabolite of norgestimate, in healthy women receiving 3 or more months of an oral contraceptive (Ortho Tri-Cyclen; Ortho-McNeil Pharmaceutical, Raritan, NJ), which contains EE and norgestimate.

Effects of an oral contraceptive (norgestimate/ethinyl estradiol) on bone mineral density in adolescent females with anorexia nervosa: a double-blind, placebo-controlled study. [2006.12]
PURPOSE: To evaluate the effect of an oral contraceptive (OC) on bone mineral density (BMD) in adolescent females with anorexia nervosa (AN) or eating disorder not otherwise specified (EDNOS)... CONCLUSIONS: In a group of adolescent females with AN or EDNOS, treatment with a triphasic OC for 13 cycles did not have a statistically significant effect on LS or hip BMD.

Effects of an oral contraceptive (norgestimate/ethinyl estradiol) on bone mineral density in women with hypothalamic amenorrhea and osteopenia: an open-label extension of a double-blind, placebo-controlled study. [2005.09]
OBJECTIVE: The effects of long-term triphasic oral contraceptive administration on bone mineral density (BMD) were investigated in premenopausal women with hypothalamic amenorrhea (HA) and osteopenia... CONCLUSIONS: Long-term administration of triphasic NGM/EE to osteopenic women with HA may increase total lumbar spine BMD.

Superiority of a combined contraceptive containing drospirenone to a triphasic preparation containing norgestimate in acne treatment. [2004.08]
This double-blind study compared the efficacy and tolerability of a combined oral contraceptive containing 30 microg ethinyl estradiol and 3 mg drospirenone (EE/DRSP; Yasmin) with a triphasic preparation containing 35 microg EE and 0.180, 0.215, 0.250 mg norgestimate (EE/NGM; Pramino, also known as Ortho Tri-Cyclen) in the treatment of acne vulgaris.

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Clinical Trials Related to Ortho TRI-Cyclen (Norgestimate / Ethinyl Estradiol)

TBTC Study 27/28 PK: Moxifloxacin Pharmacokinetics During TB Treatment [Completed]
This substudy of TBTC Studies 27 and 28 compares 1) the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the pharmacokinetics of moxifloxacin among patients with tuberculosis being treated with multidrug therapy (isoniazid or ethambutol, rifampin, and pyrazinamide) to those of healthy volunteers receiving moxifloxacin plus rifampin. It also evaluates the association between polymorphisms of MDR1 genotype (P-glycoprotein) and rifampin pharmacokinetic parameters, the effect of polymorphisms of MDR1 genotype and/or rifampin pharmacokinetics on isoniazid pharmacokinetic parameters adjusted for N-acetyltransferase genotype (NAT2), and determines by multivariate regression analyses the associations between moxifloxacin or rifampin pharmacokinetic parameters and markers of tuberculosis disease severity including the covariates of two-month culture positivity, cavitary lung disease, Body Mass Index, weight, duration of study treatment prior to PK, co-morbidities and C-reactive protein. Healthy volunteers and TB patients receive frequent scheduled blood draws during a 24 hour period after ingesting a dose of TB drugs.

A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease [Recruiting]
A prospective, randomized, double dummy, double blind, multi-center multinational trial comparing the efficacy and safety of moxifloxacin 400 mg PO QD 24 hours for 14 days to that of levofloxacin 500 mg PO QD 24 hours plus metronidazole 500 mg BID for 14 days in subjects with an uncomplicated pelvic inflammatory disease. Moxifloxacin, Metronidazole, and Levofloxacin in Asia (MONALISA Study).

Prospective Randomized Comparison of Zymar(Gatifloxacin) and Vigamox (Moxifloxacin) in Killing Conjunctival Bacterial Flora Following a One-Hour Application [Recruiting]
Topical ophthalmic antibiotics are common prescribed just prior to eye surgery to lower the risk of infection. Previous studies have suggested that antibiotics containing a preservative (Zymar) kill bacteria much quicker than those without a preservative (Vigamox). The purpose of this research is to compare how quickly to the two commonly prescribed antibiotics eliminate bacteria from the eye surface.

Effectiveness Study of Zymar Versus Vigamox for Preoperative Sterilization of the Ocular Surface After Loading Dose [Active, not recruiting]
The purpose of this study is to analyze the effect of Zymar and Vigamox on ocular surface bacteria. We believe that Zymar will eradicate more ocular surface bacteria than Vigamox.

Pharmacokinetic Issues of Moxifloxacin Plus Rifapentine [Active, not recruiting]
The purpose of this study is to determine the pharmacokinetics (how a drug is absorbed, distributed, and eliminated by the body) of moxifloxacin alone versus moxifloxacin given with rifapentine. Researchers believe that understanding how these tuberculosis drugs interact when given together may help to determine the best drug treatment plan for use in future studies. Volunteers will take moxifloxacin daily by mouth for the first part of the study and then moxifloxacin in combination with rifapentine during the second part of the study. Sixteen healthy men and women will be recruited from Johns Hopkins University School of Medicine to volunteer for this study. They will be required to stay in the inpatient unit twice, each time for 84 hours. Study procedures will include having a tube placed in a vein to draw several blood samples over time. Volunteers will participate in the study for a maximum of 48 days, including screening and follow-up visits.

more trials >>

Reports of Suspected Ortho TRI-Cyclen (Norgestimate / Ethinyl Estradiol) Side Effects

Pregnancy ON Oral Contraceptive (8)Maternal Exposure During Pregnancy (8)Pulmonary Embolism (5)Thrombosis (3)Abortion Spontaneous (3)Adverse Event (3)Nausea (3)Metrorrhagia (3)Deep Vein Thrombosis (3)Drug Dose Omission (2)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 22 ratings/reviews, Ortho TRI-Cyclen has an overall score of 7.36. The effectiveness score is 9.09 and the side effect score is 7.27. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Ortho TRI-Cyclen review by 26 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Birth Control
Dosage & duration:   Medium (dosage frequency: once daily) for the period of 5 years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   No undesired pregnancies, lighter period
Side effects:   none
Comments:   One pill daily.

 

Ortho TRI-Cyclen review by 18 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   Birth Control
Dosage & duration:   Standard (dosage frequency: once a day) for the period of It's been 7 months
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   Highly effective in birth control, actually stopped my daily headaches, made me regular
Side effects:   Extreme mood swings, unpredictable periods of depression/anger. Not only have I experience these drastic out-lashes of extreme anger onto others for no logical reason, my friend, also on the pill, experienced the same effect. She's stopped taking it, but I can't for fear of being unprotected.
Comments:   One pill a day for 21 days before a 7 day placebo.

 

Ortho TRI-Cyclen review by 18 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Birth prevention
Dosage & duration:   Medium (dosage frequency: once everyday) for the period of 5 1/2 Months
Other conditions:   N/A
Other drugs taken:   N/A
  
Reported Results
Benefits:   Although this type of birth control has more cons than pros, it did help with my cramps. It's also effective with the prevention of pregnancy. (Along with use of condoms as well)
Side effects:   Heavy Cycle, Cramps, Hot Flashes, Fatigue, Long Lasting Cycles. It's only been 5 1/2 months, but i'm concidering changing to a different bc. This is my first time using any kind of bc, unfortunately due to the constant hassel, i'm not happy with the results.
Comments:   I Hate This Birth Control, I Would Not Suggest This To Anyone.

See all Ortho TRI-Cyclen reviews / ratings >>

Page last updated: 2011-12-09

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