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.
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NEWS HIGHLIGHTS
Published Studies Related to Ovral (Norgestrel)
Prevention of tamoxifen induced endometrial polyps using a levonorgestrel releasing intrauterine system long-term follow-up of a randomised control trial. [2009.09]
OBJECTIVES: In a RCT, we have previously shown that the levonorgestrel intrauterine system (LNG-IUS, Mirena) produces a decidual response protecting the endometrium at one year follow-up. We here report on the long-term follow-up of this group of women, to test the hypothesis that a LNG-IUS could prevent the pro-proliferative uterine responses of tamoxifen for up to 4.5 years... CONCLUSION: This study confirms that LNG-IUS induces benign endometrial changes and prevents endometrial polyps but only during its use in women taking tamoxifen. Endometrial thickness is a risk factor for the development of polyps.
The effect of levonorgestrel-releasing intrauterine device on menorrhagia in women taking anticoagulant medication after cardiac valve replacement. [2009.08]
BACKGROUND: This study was conducted to evaluate the effect of levonorgestrel-releasing intrauterine devices (LNG-IUDs) on menorrhagia in patients receiving anticoagulant therapy after cardiac valve replacement... CONCLUSION: LNG-IUDs can be considered as an effective non-surgical treatment for menorrhagia in women receiving anticoagulant therapy after cardiac valve replacement.
Effects of doxycycline on serum and endometrial levels of MMP-2, MMP-9 and TIMP-1 in women using a levonorgestrel-releasing subcutaneous implant. [2009.06]
BACKGROUND: Endometrial spotting and/or bleeding (ESB) occurs in levonorgestrel subcutaneous implant (LNG SI) users. Matrix metalloproteinases (MMPs) may play a role in ESB... CONCLUSION: LNG SI increased serum MMP-9 and TIMP-1 levels, while DOX decreased both serum and endometrial MMP-9 levels.
A Canadian, multicentre study comparing the efficacy of a levonorgestrel-releasing intrauterine system to an oral contraceptive in women with idiopathic menorrhagia. [2009.04]
OBJECTIVES: To evaluate the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) compared with a combined oral contraceptive containing 1 mg norethindrone acetate and 20 mg ethinyl estradiol (OC1/20) in reducing menstrual blood loss (MBL) in women with idiopathic menorrhagia... CONCLUSION: Both the LNG-IUS and the combined oral contraceptive effectively decreased menstrual blood loss in women with idiopathic menorrhagia. The overall clinical benefit was more pronounced with LNG-IUS than with OC1/20.
Effect of sexual intercourse on the absorption of levonorgestrel after vaginal administration of 0.75 mg in Carraguard gel: a randomized, cross-over, pharmacokinetic study. [2009.02]
BACKGROUND: The Population Council studied a pre-coital contraceptive microbicide vaginal product containing levonorgestrel (LNG) as active component and Carraguard gel as a vehicle (Carra/LNG gel) for couples who engage in occasional unplanned intercourse. The objective of this study was to evaluate the effect of sexual intercourse after vaginal application of Carra/LNG gel on serum levels of LNG in women and to assess LNG absorption by the male partner... CONCLUSION: Sexual intercourse does not appear to interfere with vaginal absorption of LNG after application of a Carra/LNG gel. A vaginal pre-coital contraceptive gel is feasible.
Clinical Trials Related to Ovral (Norgestrel)
Observational Trial With Leios/Alesse [Completed]
A prospective, observational study (Anwendungsbeobachtung [AWB]) of the prescribing and
administration practices of German gynecologists with Leios® Dragées.
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
Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache [Recruiting]
The aim of the present study is to investigate whether women taking a new combined oral
contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone
withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle
compared to a commonly used contraceptive pill (Microgynon).
Effects of SH T00658ID on Libido [Recruiting]
The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering
from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no
longer than one year will express the same level of sexual distress when taking SH T00658ID
compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.
A Study to Evaluate the Pharmacokinetic Drug Interaction Between Multiple Doses of JNJ-31001074 and a Single Dose of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Women [Not yet recruiting]
The main purpose of this research study is to evaluate the effect of multiple doses of an
investigational drug known as JNJ-31001074 on the single dose of combination oral
contraceptive Ovral-L containing ethinyl estradiol and levonorgestrel in healthy women who
cannot bear children. This study will look at the safety, tolerability (how the drug makes
you feel) and pharmacokinetics (what your body does to the drug) of either drug alone and in
combination in healthy women.
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