DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Ortho-Cept (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 are strongly advised not to smoke.

 

ORTHO-CEPT SUMMARY

ORTHO-CEPT® TABLETS
(desogestrel and ethinyl estradiol)

ORTHO-CEPT Tablets provide an oral contraceptive regimen of 21 light orange round tablets each containing 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).

ORTHO-CEPT Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
See all Ortho-Cept indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Ortho-Cept (Desogestrel / Ethinyl Estradiol)

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.

A randomized study on the influence of oral contraceptives containing ethinylestradiol combined with drospirenone or desogestrel on lipid and lipoprotein metabolism over a period of 13 cycles. [2004.04]
In this open-label, randomized study we compared the influence of a new oral contraceptive containing 30 microg ethinylestradiol and 3 mg drospirenone (EE + DRSP = Yasmin), with a reference preparation containing 30 microg ethinylestradiol and 150 microg desogestrel (EE + DSG = Marvelon) on the lipid profile.

Glucose metabolism and insulin resistance in women with polycystic ovary syndrome during therapy with oral contraceptives containing cyproterone acetate or desogestrel. [2003.08]
Oral contraceptives slightly deteriorate insulin sensitivity. The present study investigated whether they may further unbalance the glucose metabolism of lean women with polycystic ovary syndrome (PCOS)... The long-term metabolic effects of these two compounds on women with PCOS require further investigations.

A randomized study over 13 cycles to assess the influence of oral contraceptives containing ethinylestradiol combined with drospirenone or desogestrel on carbohydrate metabolism. [2003.06]
In this open-label, randomized study we compared the influence of a new oral contraceptive containing 30 microg ethinylestradiol and 3 mg drospirenone (Yasmin) with a reference preparation containing 30 microg ethinylestradiol and 150 microg desogestrel (Marvelon) on variables of carbohydrate metabolism by means of oral glucose tolerance tests at baseline and in the 6th and 13th treatment cycle...

more studies >>

Clinical Trials Related to Ortho-Cept (Desogestrel / Ethinyl Estradiol)

NuvaRing Versus Marvelon in the Coordination of In Vitro Fertilization Cycles [Recruiting]
Presently, a long protocol in an In Vitro Fertilization (IVF) cycle, patients need to take Marvelon, a drug that inhibits the follicular development at the beginning of the cycle in order to better control and also plan the onset of the ovary stimulation with gonadotropin.

Marvelon is taken daily as soon as menstruation starts for a period of 14 to 21 days. Ideally, it has to be taken at the same time everyday and not be forgotten. This may cause higher stress level for some users. Presently on the market, there is a ring-shaped contraceptive device inserted in the vagina at day 1 of the cycle called NuvaRing. The purpose of this device is similar to an oral contraceptive. However, the benefit of NuvaRing is that it can be left in place for a period of up to 35 days without any other manipulation and keep an adequate rate of hormone for contraception. Moreover, NuvaRing shows better hormone stability in the blood. Although the side effects and the benefits are comparable for the two treatments, some studies have shown that more patients would respect the treatment with NuvaRing and that the level of satisfaction would be higher in women using NuvaRing when contraception is needed.

The purpose of the study is to compare the rate of satisfaction as well as the level of stress in women using Marvelon daily or NuvaRing with single insertion in a long protocol. Moreover, this study allow us to verify if using NuvaRing, a vaginal contraceptive releasing constant daily doses for up to 35 days will allow us to facilitate the planning of In Vitro Fertilization cycles in long protocol.

A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Mercilon. [Completed]
The purpose of the study was to compare the contraceptive efficacy and safety of the transdermal patch to Mercilon.

New Treatments for Troublesome Bleeding in Implanon Users [Not yet recruiting]
Most Implanon users experience a reduction in the frequency and volume of menstrual bleeding, but a substantial minority experience unpredictable and frequent and/or prolonged episodes of bleeding. This is a double blind, placebo controlled, randomised study with an additional randomised non-blinded arm. Two hundred women between the ages of 18-45 years, who are Implanon users with prolonged or frequent breakthrough bleeding (WHO definition) will be recruited and randomised into 4 equal-sized treatment groups of 50 women assigned to Marvelon 7 days or 21 days, NuvaRing 21 days or placebo. Recruited subjects will maintain a daily menstrual diary chart for a minimum of 90 days prior to randomisation, and will be enrolled into the treatment phase provided that they have met one of the World Health Organization criteria for prolonged or frequent bleeding Following the initial 90 day record, eligible women will begin designated treatment on day 1 of the next episode of bleeding or spotting. Analysis of the subsequent menstrual pattern will begin from day 1 of that bleeding/spotting episode and will continue through 90 days.

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

Evaluation of an Oral Contraceptive Containing 30 mg Ethinyloestradiol and 150 mg Desogestrel on Women's Health [Recruiting]
The desogestrel (150 mg) in combination with ethinyl estradiol (EE, 30 mg) is known as Marvelon in European countries. Previous studies revealed that the Marvelon is good and safe for women. As a study from Thailand showed that the Marvelon to be effective and acceptable in Thai women. Moreover compared to Caucasian women, the incidences of irregular bleeding and side effects were apparently lower in these Asian women . Although Marvelon was used in many countries but it's efficacy didn't reported among Iranian women.

more trials >>

Reports of Suspected Ortho-Cept (Desogestrel / Ethinyl Estradiol) Side Effects

Pulmonary Embolism (9)Thrombosis (4)Intracardiac Thrombus (4)Hypercoagulation (4)Pain in Extremity (2)Syncope (2)Pulmonary Hypertension (1)OFF Label USE (1)Smear Cervix Abnormal (1)Uterine Leiomyoma (1)more >>


Page last updated: 2006-01-31

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014