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Apri (Desogestrel / Ethinyl Estradiol) - Summary

 



BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

 

APRI SUMMARY

Apri®
(desogestrel and ethinyl estradiol) Tablets

Apri 28 Day Regimen blister cards for desogestrel and ethinyl estradiol tablets provide an oral contraceptive regimen of 21 round rose-colored tablets. Each rose-colored “active” desogestrel and ethinyl estradiol tablet for oral administration contains 0.15 mg desogestrel (13-ethyl-11- methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol).

Apri (desogestrel and ethinyl estradiol) Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.


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NEWS HIGHLIGHTS

Media Articles Related to Apri (Desogestrel / Estradiol)

Health Highlights: April 22, 2009
Source: MedicineNet Colon Polyps Specialty [2009.04.23]
Title: Health Highlights: April 22, 2009
Category: Health News
Created: 4/23/2009 2:00:00 AM
Last Editorial Review: 4/23/2009

Nobel Laureate Claims The 2010 Herbert Tabor Lectureship
Source: Conferences News From Medical News Today [2009.11.12]
Phillip A. Sharp, a world leader of research in molecular biology and biochemistry and an institute professor at the Massachusetts Institute of Technology, has been named winner of the American Society for Biochemistry and Molecular Biology Herbert Tabor/Journal of Biological Chemistry Lectureship. Sharp will give his award lecture, titled "The Biology of small RNAs," at the 2010 annual meeting at 6 p.m. Saturday, April 24, in Anaheim, Calif.

Judgement In Favour Of NICE On Judicial Review Of Abatacept For Rheumatoid Arthritis Guidance
Source: Arthritis / Rheumatology News From Medical News Today [2009.11.10]
The High Court has ruled in favour of NICE by dismissing the application from Bristol Myers Squibb (BMS), the manufacturer of abatacept, for a judicial review of the NICE guidance on the use of abatacept for the treatment of rheumatoid arthritis. In April 2008, NICE published final guidance which did not recommend abatacept as a treatment option for people with rheumatoid arthritis.

Light Shed On Gastroschisis Birth Defect By Local Health Investigation
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2009.11.09]
Results of an investigation conducted by University of Nevada, Reno researchers, public health officials and area physicians published in the Archives of Pediatrics & Adolescent Medicine, indicate that Washoe County experienced a cluster of a particular birth defect, gastroschisis, during the period April 2007 - April 2008. Subsequent review of medical records since the study's conclusion indicates that while the rate is still elevated, the cluster appears to have subsided.

Montreal Researcher, Physician And Teacher Phil Gold To Be Inducted Into The Canadian Medical Hall Of Fame
Source: Medical Students / Training News From Medical News Today [2009.10.22]
Prof. Heather Munroe-Blum, Principal and Vice-Chancellor of McGill University, and the Hon. Arthur T. Porter, Director General and CEO of the McGill University Health Centre (MUHC), welcome the news that Dr. Phil Gold is to be inducted into The Canadian Medical Hall of Fame. In 1965, Dr. Gold co-discovered the carcinoembryonic antigen (CEA), the first clinically useful human tumour marker that revolutionized the diagnosis and management of cancer. At a ceremony in April 2010, Dr.

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Published Studies Related to Apri (Desogestrel / Estradiol)

Route of administration of contraceptives containing desogestrel/etonorgestrel and insulin sensitivity: a prospective randomized study. [2009.07]
BACKGROUND: The study was conducted to investigate whether hormonal contraceptives administered via the oral and vaginal route exert a similar effect on insulin sensitivity (SI)... CONCLUSIONS: The present data indicate that in contrast to OC use, vaginal contraception with the ring does not deteriorate SI. The vaginal ring may represent an appropriate choice for long-term contraception in women at risk for developing diabetes mellitus or metabolic syndrome.

Insulin sensitivity and lipid metabolism with oral contraceptives containing chlormadinone acetate or desogestrel: a randomized trial. [2009.02]
BACKGROUND: Second-generation and third-generation oral contraceptives containing 30 mcg or more of ethinylestradiol (EE) decrease insulin sensitivity (SI). In this study, we investigated whether SI is decreased by contraceptives containing lower doses EE or by progestins with antiandrogenic properties... CONCLUSIONS: The present study confirms that DSG, even when associated with low EE dose, decreases SI. By contrast, EE/CMA does not deteriorate SI and induces a favorable lipid profile.

A prospective study on the effects on hemostasis of two oral contraceptives containing drospirenone in combination with either 30 or 20 microg ethinyl estradiol and a reference containing desogestrel and 30 microg ethinyl estradiol. [2006.04]
PURPOSE: In this open-label, randomized study, we assessed the effects on hemostasis of two combined oral contraceptives containing drospirenone (DRSP) as progestogen component... CONCLUSION: The changes in the hemostatic variables for DRSP/20EE were less pronounced compared to DSG/30EE and DRSP/30EE. The results were in accordance with previous reports on effects of similar OCs.

Effects of two combined oral contraceptives containing ethinyl estradiol 20 microg combined with either drospirenone or desogestrel on lipids, hemostatic parameters and carbohydrate metabolism. [2005.06]
OBJECTIVE: To compare the effect of ethinyl estradiol 20 microg/drospirenone 3 mg (EE 20 microg/DRSP 3 mg) administered according to a 24/4 regimen with ethinyl estradiol 20 microg/desogestrel 150 microg (EE 20 microg/DSG 150 microg) administered according to the conventional 21/7 regimen on lipid, carbohydrate and hemostatic parameters... CONCLUSION: EE 20 microg/DRSP 3 mg has a good safety profile comparable with EE 20 microg/DSG 150 microg.

Serum resistin levels in women taking combined oral contraceptives containing desogestrel or gestodene. [2004.06]
Resistin is a hormone secreted by adipose tissue that could be involved in the development of insulin resistance. Previous studies confirmed that endogenous sex steroids may influence serum resistin concentration in women... We conclude that ethinylestradiol combined with desogestrel or gestodene is unlikely to induce insulin resistance through resistin pathway.

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Clinical Trials Related to Apri (Desogestrel / Estradiol)

Continuous Versus Cyclic Use of Oral Contraceptive Pills in Adolescents [Recruiting]
The primary purpose of this study is to compare the compliance rates of adolescents who take oral contraceptives (OCPs) continuously to those who take OCPs cyclically.

A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception [Completed]
The purpose of this study is to compare the efficacy and safety of Yasmin® and Marvelon® in Chinese women requiring contraception

Predictive Factors for Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH [Active, not recruiting]
Many couples suffer from infertility. When initial measures do not help, some couples require a process called in vitro fertilization (IVF). Each month, a woman produces at most one egg. IVF helps these women make more than one egg per month. However, this involves taking hormones that stimulate the ovary to produce many (5-20) eggs at one time. The hormones are taken both by mouth and injected with a small needle. The eggs are removed from the ovary through a surgical procedure, then place in a dish for fertilization sperm to form an embryo. The embryos are grown in the laboratory then replaced into the woman's uterus 3-5 days later.

The stimulation of the ovaries is important. Doctors choose a particular drug regimen called a protocol. Often times the drug protocol involves taking the birth control pill prior to starting the injectable medication. At this time, we are unsure if taking the birth control pill prior to starting the injectable medication helps, harms, or makes no difference in a person's chance at getting pregnant. This study will randomize (like flipping a coin) couples who are going to start IVF treatment into two groups. In one group the female partner will take oral contraceptive pills for 1 month prior to starting injectable medication, while the other group they will not take oral contraceptive pills prior to starting the injectable medication. We will then follow their progress to see how many eggs they produce and how many women get pregnant.

The purpose of this study is to identify if taking the birth control pill before starting the injectable medications for one month does or does not improve how the human ovary responds to the injectable medications. We currently do not know the answer to this question. The birth control pill is used commonly before in vitro fertilization (IVF) treatment cycles because it helps control the body's response to the injectable medication and prevents the ovary from becoming over-stimulated. It also assists in the timing of IVF treatment cycles.

Oral Microdose Lupron Versus Luteal Estradiol Trial in Poor Responder In Vitro Fertilization (IVF) Patients [Recruiting]
Hundreds of thousands of couples in the United States experience infertility each year. When initial measures do not help, some couples require a process called ovarian stimulation and in vitro fertilization (IVF). Usually, a woman produces at most one egg each month. Ovarian stimulation helps these women make more than one egg per month. However, this involves taking hormones that stimulate the ovary to produce many eggs at one time. The stimulatory hormones injected with a small needle. The eggs are removed from the ovary through a surgical procedure and then placed in a dish for fertilization by sperm to form embryos. The embryos are grown in the laboratory then replaced into the woman's uterus 3-5 days later.

The stimulation of the ovaries is important. Some patients undergo ovarian stimulation for IVF but do not respond to the treatment. This is a very difficult situation because even though several ovarian stimulation protocols have been used for poor responder patients, it is not clear which protocol works best. In fact, two of the most commonly used protocols have not been directly compared.

This study will randomize (like flipping a coin) couples with a history of low response who are going to start IVF treatment into two groups. In one group the female partner will use a protocol called "E2 patch/antagonist". These women will use an estrogen patch and injected antagonist for several days before starting injectable fertility medications. The other group will use a protocol called "OCP/microdose". This group of women will use oral contraceptive pills (OCPs) and small doses of lupron along with the other injectable fertility medications. We will then follow their progress to see how many eggs they produce and how many women get pregnant.

Hormonal Contraception & Vaginal Health [Recruiting]
The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. We plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).

more trials >>

Page last updated: 2009-11-12

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