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Low-Ogestrel (Norgestrel / Ethinyl Estradiol) - Summary

 



LOW-OGESTREL SUMMARY

WATSON PHARMA
IN-5186/S
PHYSICIAN LABELING
Low-Ogestrel ®
(Norgestrel and Ethinyl Estradiol Tablets USP,
0.3 mg/0.03 mg)
Rx only

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Low-Ogestrel ® Tablets (norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) provide an oral contraceptive regimen consisting of 21 white tablets followed by 7 peach tablets.

Low-Ogestrel®(norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.


See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Low-Ogestrel (Norgestrel / Estradiol)

US funding revamps African contraceptive drive (AFP)
Source: Y! Health News Search RSS Feed [2009.11.18]
AFP - A new 12 million dollar family planning drive launched here Wednesday highlights how Obama administration funding has revamped a contraception drive in Africa and developing states, UN officials said, noting a sharp turnaround from the Bush era.

Terrence Higgins Trust Welcomes Department Of Health Nursing Degree Announcement, UK
Source: HIV / AIDS News From Medical News Today [2009.11.15]
HIV and sexual health charity Terrence Higgins Trust has welcomed the announcement by the Department of Health that all new nurses will be educated to degree level from 2013. Terrence Higgins Trust (THT) currently employs nurses who work in Chlamydia screening programmes for young people, HIV testing clinics and clinics that offer contraception services and screening for sexually transmitted infections.

more news >>

Published Studies Related to Low-Ogestrel (Norgestrel / Estradiol)

Low Incidence of Severe Respiratory Syncytial Virus Infections in Lung Transplant Recipients Despite the Absence of Specific Therapy. [2009.10.17]
BACKGROUND: Respiratory syncytial virus (RSV) infections in lung transplant recipients (LTRs) have been associated with significant morbidity and mortality. Immunoglobulins, ribavirin and palivizumab are suggested treatments for both pre-emptive and therapeutic purposes. However, in the absence of randomized, placebo-controlled trials, efficacy is controversial and there is toxicity as well as cost concerns... CONCLUSIONS: Our data suggest that mild RSV infections in LTRs might evolve favorably in the absence of specific anti-viral therapy. However, this observation needs confirmation in a large clinical trial specifically investigating the development of BOS in untreated vs treated patients.

The contrast media and nephrotoxicity following coronary revascularization by primary angioplasty for acute myocardial infarction study: design and rationale of the CONTRAST-AMI study. [2009.10.13]
BACKGROUND: Contrast-induced acute kidney injury (CI-AKI) is a complex syndrome of acute renal failure occurring after the administration of contrast media and contributing to prolonged hospital stay and mortality. The risk of CI-AKI is higher among patients undergoing primary percutaneous coronary interventions for acute myocardial infarction (AMI), but its clinical relevance in such setting has only been evaluated by small sample size single-center studies and retrospective or observational analyses. Furthermore, whereas high-osmolar contrast media was shown to have direct nephrotoxicity, the role of low-osmolar and iso-osmolar agents is still debated... CONCLUSION: The CONTRAST-AMI study will provide information on the effects of iodixanol and iopromide on the incidence of CI-AKI and tissue-level perfusion in patients with AMI.

Final 5-year results of the TAXUS II trial: a randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for de novo coronary artery lesions. [2009.10.13]
CONCLUSIONS: TAXUS II is the first large TAXUS trial to have reached 5-year follow-up. Both the SR and MR stents lowered the rates of target-vessel and target-lesion revascularization, which indicates their sustained efficacy. Furthermore, the low overall rates of all death, myocardial infarction, and stent thrombosis support the long-term safety of the TAXUS stent system.

Effects of Aromatase Inhibition on Bone Mineral Density and Bone Turnover in Older Men with Low Testosterone Levels. [2009.10.09]
Context: Aging is associated with declining gonadal steroid production, low bone mineral density (BMD), and fragility fractures... Aromatase inhibition does not improve skeletal health in aging men with low or low normal testosterone levels.

Naftopidil for the treatment of lower urinary tract symptoms compatible with benign prostatic hyperplasia. [2009.10.07]
CONCLUSIONS: There are no data from placebo controlled trials regarding the efficacy of naftopidil in men with symptomatic BPH. Limited information suggests that treatment with naftopidil provides short-term improvement in urinary symptom-scale scores (total IPSS/AUA), QoL (quality of life) score, and urinary symptoms from baseline comparable to low-dose tamsulosin. Adverse effects due to naftopidil were few and usually mild.

more studies >>

Clinical Trials Related to Low-Ogestrel (Norgestrel / Estradiol)

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

Effect of Cetrorelex Acetate on Ovarian Function in Women Undergoing Chemotherapy [Not yet recruiting]
This study will examine whether the drug cetrorelex acetate (Cetrotide[Registed Trademark]) can protect ovarian function in women undergoing chemotherapy. Some cancer treatments are known to cause a change in women's periods or to cause menstruation to stop completely, so that they cannot become pregnant. Cetrorelex acetate has been used for many years to lower hormone levels and stop periods in patients undergoing in vitro fertilization treatments. This study will see if making the ovaries inactive may protect them from being affected by certain cancer drugs, and thus preserve fertility.

Women up to age 21who have begun menstruating, who have their uterus and at least one functioning ovary, and who are undergoing chemotherapy with cyclophosphamide, busulfan, nitrogen mustard or L-phenalanin mustard may be eligible for this study.

Participants undergo the following procedures during this 24-month study:

Baseline evaluation

- Medical history, physical examination and blood and urine tests

- Questionnaire about quality of life, menstrual periods, vaginal bleeding and desire for

future fertility

- 3D ultrasound of abdomen

- DEXA scan to evaluate bone density

Assignment to treatment with:

- Lo ovral (contraceptive pill to prevent pregnancy and control menstrual periods) alone,

or

- Lo ovral and the study drug cetrorelex acetate, given as an injection under the skin

once a day for six menstrual cycles

Evaluations

- Transvaginal 3D ultrasound to monitor changes in the ovary - after 6 months of

cetrorelex acetate injections

- DEXA scan - after 6 months of cetrorelex acetate injections

- Blood tests for safety monitoring, pregnancy testing, endocrine tests and research uses

- every 3 months during first year, every 6 months during second year

- Questionnaire to monitor changes and quality of life - every 3 months during first

year, every 6 months during second year.

more trials >>

Page last updated: 2009-11-18

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