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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.



(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 >>


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)

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.

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]

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.

Drug Interaction Oral Contraceptive Pill (OCP) [Completed]

more trials >>

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 >>


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

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

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

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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