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