TRIPHASIL SUMMARY
Each Triphasil cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 brown tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17(alpha)-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 white tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 light-yellow tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 light-green inert tablets.
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
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NEWS HIGHLIGHTS
Published Studies Related to Triphasil (Levonorgestrel / Ethinyl Estradiol)
Haemostatic effects of a new combined oral contraceptive, nomegestrol acetate/17beta-estradiol, compared with those of levonorgestrel/ethinyl estradiol. A double-blind, randomised study. [2011.03]
Use of oral contraceptives (OC) that combine a progestogen with synthetic ethinyl estradiol (EE) is associated with increased risk of venous thromboembolism. NOMAC/E2 is a new monophasic OC that combines nomegestrol acetate (NOMAC), a highly selective progestogen, with 17beta-estradiol (E2)...
Continuous, daily levonorgestrel/ethinyl estradiol vs. 21-day, cyclic levonorgestrel/ethinyl estradiol: efficacy, safety and bleeding in a randomized, open-label trial. [2009.12]
BACKGROUND: This Phase 3, randomized, open-label, multicenter study conducted at 44 sites in Europe evaluated the safety and efficacy of a continuous, daily regimen of levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg compared with a 21-day, cyclic LNG 100 mcg/EE 20 mcg regimen... CONCLUSIONS: Continuous LNG 90 mcg/EE 20 mcg was shown to be a safe and effective OC in this direct comparison to a cyclic OC. Suppression of menses and the potential for no bleeding requiring sanitary protection may be provided by this continuous, low-dose OC.
Comparative effects of a contraceptive vaginal ring delivering a nonandrogenic progestin and continuous ethinyl estradiol and a combined oral contraceptive containing levonorgestrel on hemostasis variables. [2006.07]
OBJECTIVE: This study aimed to compare the effects on hemostasis variables of a contraceptive vaginal ring with those of an oral contraceptive... CONCLUSION: The contraceptive vaginal ring affected some measured hemostasis variables and sex hormone-binding globulin differently from the oral contraceptive, most likely because of difference in androgenicity of the progestins. The results suggest that the contraindications for oral contraceptive use would also apply to the tested contraceptive vaginal ring.
A 1-year randomized study to evaluate the effects of a dose reduction in oral contraceptives on lipids and carbohydrate metabolism: 20 microg ethinyl estradiol combined with 100 microg levonorgestrel. [2005.02]
OBJECTIVES: To evaluate the impact on lipid and carbohydrate variables of a combined one-third ethinyl estradiol (EE)/levonorgestrel (LNG) dose reduction in oral contraceptives... CONCLUSION: Similar effects on the lipid and carbohydrate profiles were found for both preparations. The balanced one-third EE dose reduction in this new oral contraceptive caused slightly lower, but insignificant, changes in the lipid and carbohydrate variables compared with the reference treatment.
Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel: a randomized trial. [2005.02]
BACKGROUND: This trial was conducted to compare cycle control with vaginal ring a combined contraceptive vaginal ring, and a combined oral contraceptive (COC) delivering 30 mug ethinylestradiol (EE) and 150 mug levonorgestrel... CONCLUSIONS: Cycle control with vaginal ring was excellent and superior to that of a COC containing 30 mug EE.
Clinical Trials Related to Triphasil (Levonorgestrel / Ethinyl Estradiol)
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale [Completed]
This is a 4-arm study to evaluate and compare bleeding patterns between three different
doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants
will receive physical and gynecological exams, including Pap smear. During the study, all
participants will be required to complete a diary
A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil. [Completed]
The purpose of the study was to compare the contraceptive efficacy and safety of the
transdermal patch to Triphasil.
AZD6140 Oral Contraceptive Interaction Study [Completed]
Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects [Completed]
This open-label, fixed-sequence crossover study aims to evaluate the effect of GSK1265744
(744) oral administration on the pharmacokinetics (PK) and pharmacodynamics (PD) of a
commonly used oral contraceptive (OC) product (combination of ethinyl estradiol and
levonorgestrel), in 20 healthy female subjects. Each subject will participate in a Run-in
Period (if needed), followed by a single-sequence Treatment Period. Subjects will receive
oral contraceptive containing Levonorgestrel and Ethinyl Estradiol on Days 1 to 21 and be OC
free on Days 22 to 28, during which withdrawal menses should occur. Subjects will receive OC
alone on Days 1 to 10. Levonorgestrel (LNG) and ethinyl estradiol (EE) PK will be determined
on Day 10. Subjects will then co-administer 744 and OC on Days 11 to 21. Levonorgestrel
and ethinyl estradiol PK will be determined again on Day 21 to assess if co-administration
with 744 results in a significant change in OC exposure compared to OC alone. Subjects will
return to the study center for final follow-up evaluations 7 to 14 days after the last dose
of study medication (Days 28 to 35).
Quartet Lead and Resynchronization Therapy Options [Completed]
The purpose of this Clinical Trial is to determine the percentage of patients whose
hemodynamic response improves with the different configurations offered by the new Quartet®
left ventricular lead, as a result of its four electrodes, with respect to the
configurations offered by a standard bipolar lead.
Furthermore, the optimal stimulation configuration will be determined from a comparison with
traditional configurations.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Triphasil has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Triphasil review by 39 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | birth control |
| Dosage & duration: | | one a day (dosage frequency: daily) for the period of more than 10 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | prevented unwanted pregnancy. Regular menstrual cycles. |
| Side effects: | | None for me. |
| Comments: | | I have friends who hated their birth control pills -- their pills made them feel bloated and fat. I had none of those side effects while on TriPhasil/Trivora. It's really simple -- just take one a day -- and pretty effective. It worked for me for more than 10 years. A bonus: my menstrual cycles, which used to be somewhat irregular, became as predictable as clockwork. |
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| | Triphasil review by 33 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | contraception |
| Dosage & duration: | | 1 pill each day taken daily for the period of 10 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | general medical benefits: contraception, hormone management. Personal benefits: i controlled my weight better, skin looked more radiant and menstruation pains were alot less than when i was not on the medication. As i grew older though i have been warned of being on contraception after 32 and I am also a smoker, this apparently increases the risk of cancer. However, after terminating the pill I had a huge amount of hair loss over 8 months which I was never warned about |
| Side effects: | | side effects - when leaving the pill - i started losing my hair - alot of it |
| Comments: | | daily dosage, usually taken at night time, managed my weight, and helped with my skin as well as a contraceptive |
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| | Triphasil review by 33 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | contraception |
| Dosage & duration: | | 1 pill each day taken daily for the period of 10 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | general medical benefits: contraception, hormone management. Personal benefits: i controlled my weight better, skin looked more radiant and menstruation pains were alot less than when i was not on the medication. As i grew older though i have been warned of being on contraception after 32 and I am also a smoker, this apparently increases the risk of cancer. However, after terminating the pill I had a huge amount of hair loss over 8 months which I was never warned about |
| Side effects: | | side effects - when leaving the pill - i started losing my hair - alot of it |
| Comments: | | daily dosage, usually taken at night time, managed my weight, and helped with my skin as well as a contraceptive |
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Page last updated: 2011-12-09
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