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Ovral (Norgestrel) - Summary

 
 



OVRAL SUMMARY

21 white Ovral tablets, each containing 0.5 mg of norgestrel, ( dl -13-beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.05 mg of ethinyl estradiol, (19-nor-17(alpha)-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and 7 pink inert tablets.

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptive products such as Ovral® or Ovral®-28 (norgestrel and ethinyl estradiol tablets), which contain 50 mcg of estrogen, should not be used unless medically indicated.
See all Ovral indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Ovral (Norgestrel)

An overview of four studies of a continuous oral contraceptive (levonorgestrel 90 mcg/ethinyl estradiol 20 mcg) on premenstrual dysphoric disorder and premenstrual syndrome. [2012]
and premenstrual syndrome (PMS)... CONCLUSIONS: These data, although not consistent, indicate that continuous LNG/EE

Effect of ticagrelor on the pharmacokinetics of ethinyl oestradiol and levonorgestrel in healthy volunteers. [2011.08]
BACKGROUND: Cytochrome P450 3 A is involved in ticagrelor and ethinyl oestradiol/levonorgestrel metabolism; so a potential drug-drug interaction may occur. OBJECTIVES: To assess: ticagrelor effects on ethinyl oestradiol/levonorgestrel pharmacokinetics, endogenous sex hormone levels; ethinyl oestradiol/levonorgestrel effects on ticagrelor pharmacokinetics; tolerability of ticagrelor + ethinyl oestradiol/levonorgestrel... CONCLUSIONS: Ticagrelor co-administration with ethinyl oestradiol/levonorgestrel increased ethinyl oestradiol exposure by approximately 20%, with no effect on levonorgestrel pharmacokinetics. No clinically relevant effect on contraceptive efficacy is expected with ethinyl oestradiol/levonorgestrel and ticagrelor co-administration.

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)...

A randomized clinical trial of a levonorgestrel-releasing intrauterine system and a low-dose combined oral contraceptive for fibroid-related menorrhagia. [2011.02]
OBJECTIVE: To compare the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) with that of a low-dose combined oral contraceptive (COC) in reducing fibroid-related menorrhagia... CONCLUSION: Although the rate of treatment failure was similar in both groups, the LNG-IUS was more effective in reducing MBL than the COC in women with fibroid-related menorrhagia. Copyright A(c) 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Comparison of levonorgestrel intrauterine system versus hysterectomy on efficacy and quality of life in patients with adenomyosis. [2011.02]
OBJECTIVE: To compare the levonorgestrel intrauterine system (LNG-IUS) with hysterectomy in patients with adenomyosis and to study the effects of both treatments on quality of life (QOL)...

more studies >>

Clinical Trials Related to Ovral (Norgestrel)

Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne� or Placebo. [Recruiting]

Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects [Recruiting]
A crossover study to assess the effect of repeated doses of fostamatinib on the levels of oral contraceptive (Microgynon® 30) in the blood of healthy female subjects. The study will consist of a screening period of up to 35 days, followed by 2 treatment periods (28 days each) of an oral contraceptive (Microgynon® 30) in the absence and presence of fostamatinib. The study will also evaluate the safety and tolerability of fostamatinib in combination with an oral contraceptive

Observational Trial With Leios/Alesse [Completed]
A prospective, observational study (Anwendungsbeobachtung [AWB]) of the prescribing and administration practices of German gynecologists with Leios® Dragées.

A Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female Subjects [Recruiting]

Investigate Impact of Yasmin vs Microgynon on Hemostasis Parameters in Healthy Women [Completed]
The objective of this study was to investigate the impact of the oral contraceptive YASMIN (containing: drospirenone 3 mg/ethinyl estradiol 30 mcg) in comparison with the oral contraceptive MICROGYNON (containing: levonorgestrel 150 mcg/ethinyl estradiol 30mcg) on factors of blood coagulation and fibrinolysis in female subjects

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Page last updated: 2013-02-10

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