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.
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
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)...
Clinical Trials Related to Ovral (Norgestrel)
Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer [Completed]
Randomized phase II trial to compare two different hormone therapy regimens in preventing
endometrial cancer in women who have a genetic risk for hereditary nonpolyposis colon
cancer. Hormone therapy may prevent the development of endometrial cancer in women with a
genetic risk for hereditary nonpolyposis colon cancer. It is not yet known which hormone
therapy regimen is more effective in preventing endometrial cancer.
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg [Completed]
A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences,
crossover, randomized, prospective design was chosen with a washout of 14 days between the
two study periods. Treatment groups are balanced with the same number of male healthy
volunteers who were randomly assigned to the study drug administration sequences.
A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA (a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme) and CILEST (an Oral Contraceptive) [Completed]
Drug Interaction Oral Contraceptive Pill (OCP) [Completed]
A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities [Completed]
The purpose of this study is to establish the bioequivalence of the hormones norgestimate,
norelgestromin, and ethinyl estradiol in norgestimate/ethinyl estradiol (NGM/EE) tablets,
formulated by wet process compared with the same hormones in NGM/EE tablets, formulated by
dry process, in healthy women.
Page last updated: 2013-02-10