Home » Drug Information » FDA Approved Drugs » 2000
Medical Areas: Endocrinology | Obstetrics/Gynecology (Women’s Health)
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Asta Medica
Approval Status: Approved August 2000
Treatment Area: For the prevention of premature ovulation in women undergoing controlled ovarian stimulation
Cetrotide has been developed to prevent premature ovulation in
women undergoing controlled ovarian stimulation for assisted
reproductive technologies (ART). Cetrotide blocks the effects of a
natural hormone, called gonadotropin-releasing hormone (GnRH). GnRH
controls the secretion of another hormone, called luteinizing
hormone (LH), which induces ovulation during the menstrual cycle.
During hormone treatment for ovarian stimulation, premature
ovulation may lead to eggs that are not suitable for fertilization.
Cetrotide blocks such undesirable premature ovulation.
The effectiveness of Cetrotide has been examined in five
clinical trials (two phase II and three phase III trials). Two dose
regimens were investigated in these trials: either a single dose
per treatment cycle or multiple dosing. In the phase II studies, a
single dose of 3 mg was established as the minimal effective dose
for the inhibition of premature LH surges with a protection period
of at least four days. When Cetrotide is administered in a
multidose regimen, 0.25 mg was established as the minimal effective
dose. The extent and duration of LH-suppression was found to be
In the phase III program, efficacy of the single 3 mg dose
regimen and the multiple 0.25 mg dose regimen was established
separately in two controlled studies utilizing active comparitors.
A third non-comparative study evaluated only the multiple 0.25 mg
dose regimen of Cetrotide.
In the five phase II and phase III trials, 184 pregnancies have
been reported out of a total of 732 patients (including 21
pregnancies following the replacement of frozen-thawed embryos). No
drug related allergic reactions were reported from these clinical
studies. (from FDA Label)
Adverse effects associated with Cetrotide include (but are not
limited to) the following:
- Reddening, itching, or swelling at injection site
Additionally, Cetrotide should not be used by individuals who
are or may be pregnant.
Mechanism of Action
GnRH induces the production and release of luteinizing hormone
(LH) and follicle stimulating hormone (FSH) from the gonadotrophic
cells of the anterior pituitary. Due to a positive estradiol
feedback at midcycle, GnRH liberation is enhanced resulting in an
LH-surge. This LH-surge induces the ovulation of the dominant
follicle, resumption of oocyte meiosis and subsequently
luteinization as indicated by rising progesterone levels.
Cetrotide competes with natural GnRH for binding to membrane
receptors on pituitary cells and thus controls the release of LH
and FSH in a dose-dependent manner. The onset of LH suppression is
approximately one hour with the 3 mg dose and two hours with the
0.25 mg dose. This suppression is maintained by continuous
treatment and there is a more pronounced effect on LH than on FSH.
An initial release of endogenous gonadotropins has not been
detected with Cetrotide, which is consistent with an antagonist
effect. (from FDA Label)
For further information on Cetrotide, please visit the web site
of Asta Medica