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Ortho TRI-Cyclen (Norgestimate / Ethinyl Estradiol) - Summary



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.



(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 >>


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.

more studies >>

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

The Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA� in Healthy Women [Completed]
The purpose of this study is to assess the bioequivalence of the contraceptive hormones of ORTHO EVRA when the patch is applied with and without an adhesive overlay.

Postmarketing Study of ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) in Relation to Venous Thromboembolism (Blood Clots), Stroke and Heart Attacks [Active, not recruiting]
The purpose of the study is to assess the occurrence of venous thromboembolism (blood clots), stroke, and heart attack in current users of ORTHO EVRA compared to current users of norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol with special attention to duration of use. The study uses data from the PharMetrics Patient-Centric Database, which is a medical claims database.

Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen� in Healthy Female Subjects [Completed]

Discontinuation of Lens Wear in New Ortho-k Children (DOEE2) [Active, not recruiting]

Continuous Use of the Contraceptive Patch and the Personal Economic Impact. [Withdrawn]
Dr. Eleanor Drey in the Department of Obstetrics, Gynecology and Reproductive Sciences UCSF is conducting a study to examine the personal and economic impact of continuous use of ORTHO EVRA, the contraceptive patch, on menstrual related symptoms for women who report having severe menstrual related symptoms.

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 >>


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

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

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

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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