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Ortho Tri-Cyclen Lo (Norgestimate / Ethinyl Estradiol) - Summary

 
 



Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

 

SUMMARY

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

ORTHO TRI-CYCLEN Lo Tablets is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.

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

In an active controlled clinical trial 1,673 subjects completed 11,003 cycles of ORTHO TRI-CYCLEN Lo use and a total of 20 pregnancies were reported in ORTHO TRI-CYCLEN Lo users.99 This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 2.36 per 100 women-years of use.


See all Ortho Tri-Cyclen Lo indications & dosage >>

NEWS HIGHLIGHTS

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

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.

Effects of a triphasic combination oral contraceptive containing norgestimate/ethinyl estradiol on biochemical markers of bone metabolism in young women with osteopenia secondary to hypothalamic amenorrhea. [2003.08]
This multicenter, double-blind, placebo-controlled, randomized study of 45 patients evaluated the short-term effects of an oral contraceptive [Ortho Tri-Cyclen, 180-250 micro g of norgestimate (NGM) and 35 microg of ethinyl estradiol (EE)] on biochemical markers of bone resorption, formation, and osteoprotegerin in young women (mean age +/- SD, 26.5 +/- 6.3 yr) with hypothalamic amenorrhea and osteopenia...

Cycle control, tolerability, and satisfaction among women switching from 30-35 microg ethinyl estradiol-containing oral contraceptives to the triphasic norgestimate/25 microg ethinyl estradiol-containing oral contraceptive Ortho Tri-Cyclen LO. [2003.07]
OBJECTIVE: To determine cycle control, tolerability, and satisfaction among women (aged 18-45) switching from oral contraceptives (OCs) containing 30-35 microg ethinyl estradiol (EE) to Ortho Tri-Cyclen LO (norgestimate 180/215/250 microg/EE 25 microg) and Loestrin Fe 1/20 (norethindrone acetate 1 mg/EE 20 microg)...

Efficacy, safety and cycle control of five oral contraceptive regimens containing norgestimate and ethinyl estradiol. [2003.06]
This randomized, multicenter, parallel group study evaluated four new oral contraceptive regimens of norgestimate (NGM) and ethinyl estradiol (EE) relative to ORTHO TRI-CYCLEN (NGM 180/215/250 microg/EE 35 microg). Healthy women (50/group) received three cycles of either ORTHO TRI-CYCLEN Lo (NGM 180/215/250 microg/EE 25 microg), one of three cyclophasic regimens (NGM cycling 180-250 microg/EE 35 microg or 25 microg) or ORTHO TRI-CYCLEN.

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Clinical Trials Related to Ortho Tri-Cyclen Lo (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.

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

Pulmonary Embolism (5)Inappropriate Schedule of Drug Administration (5)OFF Label USE (4)Metrorrhagia (4)Paget-Schroetter Syndrome (3)Pregnancy ON Oral Contraceptive (3)Maternal Exposure During Pregnancy (3)Convulsion (3)Syncope (3)Cardiac Arrest (3)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 7 ratings/reviews, Ortho TRI-Cyclen LO has an overall score of 6.86. The effectiveness score is 8.57 and the side effect score is 6.57. 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 LO review by 35 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   contraception
Dosage & duration:   white - 0.180 mg norgestimate taken once a day for the period of 4 years
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   the medicine was for contraceptive purposes, which it achieved. The medicine also regulated the periods and made them on a more regular basis. It also cleared my skin and helped with acne.
Side effects:   The only side effects included breast tendiness and a slight headache during the first 2-3 days of the period. After stopping taking the contraceptive, headaches stopped, too.
Comments:   I took one pill a day for 28 days, starting on the first day of the period. I tried to take the pill at approximately the same time each day, to improve the effectiveness of the medication.

 

Ortho TRI-Cyclen LO review by 25 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Pregnancy prevention
Dosage & duration:   Lo (dosage frequency: 1 pill per day) for the period of 4 months
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   Prevented pregnancy, acne was lighter, predictable periods
Side effects:   Extreme nausea for first 3 months, migraines during 4th month, contact lense use was disrupted, some weight gain (about 3-5 pounds) after the 3rd month, moodiness, lethargic, increased appetite, breast tenderness and enlargement
Comments:   The side effects were very severe. Sometimes I thought I was pregnant because the side effects are similar to those of pregnant women. However, during the placebo pills, my period always came. I spoke with my pharmacist and she said if I have such side effects with this lower dosage I might get more severe effects with the higher dose. I am still taking this hoping to ride out the side effects as the severity seems to lessen over time.

 

Ortho TRI-Cyclen LO review by 19 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   Heavy menstrual bleeding
Dosage & duration:   1 pill taken once a day for the period of a couple months
Other conditions:   Anxiety, depression, PTSD, hyperthyroidism
Other drugs taken:   Zoloft, PTU (Anti-thyroid medicine)
  
Reported Results
Benefits:   None... did not make my periods any lighter
Side effects:   Weight gain... I gained 10-15 pounds while on the pill and because I'm only 4'10, that 10-15 pounds REALLY SHOWS. I've tried other oral contraceptives for my heavy menstrual bleeding and all of them do the same thing... they don't help regulate my menstrual bleeding but they do make me gain weight. In the future, when I need to use a method of birth control, I will not be using oral contraceptives... EVER!
Comments:   My sister is also on this pill (for birth control) and she has experienced many side affects from it, too.

See all Ortho TRI-Cyclen LO reviews / ratings >>

Page last updated: 2007-02-12

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