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.
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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.
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NEWS HIGHLIGHTS
Published Studies Related to Ortho TRI-Cyclen (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.
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.
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)...
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.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 14 ratings/reviews, Ortho TRI-Cyclen has an overall score of 7.21. The effectiveness score is 8.71 and the side effect score is 7.57. 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 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. |
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| | Ortho TRI-Cyclen review by 25 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | birth control |
| Dosage & duration: | | standard hormone dose (dosage frequency: daily) for the period of 4 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | With proper administration I never feel too many side effects associated with hormonal imbalances. I also use it as my primary source of birth control have never become pregnant. Even during months that I failed to take it at the same time every day, I did not become pregnant. The pill is super tiny and easy to swallow. |
| Side effects: | | You have to be careful to take the appropriate dose (one pill per day at the same time). You MUST keep it on you at all times so that you are able to do so. Missing a dose would often induce my period which would linger for weeks. I also noticed a dramatic difference in the quality of my hair. Over the last few years of taking the medication I have lost over 75 percent of the super thick head of hair I once had. |
| Comments: | | The treatment is relatively simple and safe. It is also supposed to decrease your chance of cervical cancer. Take one pill each day and there is a 99 percent chance of not getting pregnant. However, you can increase your risk of blood clotting if you are a smoker. You highly advised to be smoke free throughout treatment. Once treatment stops you must seek another form of birth control. |
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| | Ortho TRI-Cyclen review by 19 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Birth Control |
| Dosage & duration: | | 1 pill taken each day for the period of 2 years |
| Other conditions: | | N/A |
| Other drugs taken: | | N/A | | |
Reported Results |
| Benefits: | | Prevented pregnancy, completely cleared up my (moderate) acne. |
| Side effects: | | Taking Ortho TRI-Cyclen had a dramatic impact on my moods. I felt slow, distant, and complacent. I felt like a dumbed-down, watered-down version of myself. The physical effects were also disturbing: I developed a dark brown discharge and grew black hairs around my nipples. But the most extreme side effects actually occurred when I went OFF the pill, which I had to attempt twice before I could get through it: I experienced the most severe depression of my life, several week-long, heavy periods, hair loss, and very bad acne. |
| Comments: | | Typical: 1 pill per day. |
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Page last updated: 2007-02-12
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