Product Name: Clomiphene Citrate
CITRATE;CLOMIPHENE CITRATE;CLOMIPHENE CITRATE
Product Categories: API;Intermediates & Fine
Mol File: 50-41-9.mol
storage temp. 2-8°C
Appearance It is white or white crystalline powder. Melting point
116.5-118 °C; it is slightly soluble in ethanol, chloroform, water,
and insoluble in ether.
Hazard Codes T
Risk Statements 60-63
Safety Statements 53-36/37-45
WGK Germany 3
Clomiphene citrate is a kind of triphenylethylene derivatives with
its structure being similar to estrogen and has a strong
anti-estrogen but weak estrogenic activity. The ovulation induction
mechanism of this product is to promote an increase in the
secretion of pituitary gonadotropins; gonadotropin stimulates the
follicle growth and maturation inside the ovary, further causing
production and secretion of luteinizing hormone with a clinical
pregnancy curing rate of 35% for patients suffering ovulation
disorders. However, for patients with primary pituitary or ovarian
dysfunction, such as primary amenorrhea, it is usually for applying
this drug for treatment. In addition, anovulation caused by factors
of other organs (such as thyroid, adrenal dysfunction) is not
suitable for subjecting to this treatment. Clomiphene citrate has
an effect of promoting the sperm production of men which is
clinically used for the treatment azoospermia. The prerequisite for
clinical application is a certain function in ovarian and a normal
or a bit lower hormone levels. It is mainly used for:
1. Ovulation induction: for the treatment of anovulatory or
inadequate luteal malfunction; infertility women who hope for
pregnancy. At the 3-5 days of menstrual bleeding or progesterone
withdrawal bleeding, orally administrate 50 mg daily and
continuously take for five days. Usually ovulation occurs at about
7 days after stopping drugs when having intercourse is easy to
increase the pregnancy rate. If the dose can induce ovulation, the
treatment can be repeated; if there is no ovulation, the daily dose
can be increased to 100 ~ 150 mg with administration in twice upon
an empty stomach for 5 consecutive days. At appropriate
indications, most patients can ovulate in the first cycle of
treatment, for patients of long-term amenorrhea; their endometrial
is not sensitive enough which requires two to three cycles of
treatment for induction menstruation. If ovulation still doesn’t
occur after three cycles, people should be reconsidered whether the
diagnosis is correct.
2. Functional uterine bleeding, secondary amenorrhea or severe
oligomenorrhea, and polycystic ovary syndrome: for people who ha
menstruation, they should begin to take drug at the 5th day of
menstrual; People without menstruation may start at any day or at
the 5th day of the in artificial cycle with 1/d 50 ~ 100mg.
3. Male with low sperm and infertility: 25mg /d/per time;
consecutively take for 25 days as one treatment course. Repeat it
after stopping for five days until the sperm count reach normal
standards; this process normally takes 3 to 12 courses. Male
patients with no sperm should not apply clomiphene citrate for
4. Senile vaginitis and non-specific vaginitis: apply one tablets
of clomiphene citrate per day; place it with vaginal suppositories
(each tablets contains clomiphene 0.1 mg and chloramphenicol 250
mg) into the vagina with a week being a course; It is reported that
it has better efficiency than chlorhexidine
5. Treatment of the anus, vulva, scrotum itching and eczema,
dermatitis, chilblains, scabies; can apply 10% clomiphene citrate
cream for treating affected area with a rapid efficacy, a long
duration and high safety.
1. The product is an anti-estrogen (fertility inducer) drug used
for treating dysfunctional uterine bleeding, polycystic ovary,
menstrual disorders and drug-induced amenorrhea and other
2. It is a kind of hormone drugs for treating luteal insufficiency,
anovulatory infertility, dysfunctional uterine bleeding.
Usage And Synthesis:
Usage Clomiphene citrate is a kind of anti-hormone drugs. It has
strong anti-estrogenic effect and weak estrogenic effects, and is
easily absorbed in the gastrointestinal tract, and can be slowly
excreted through the liver into the bile duct; it is clinically
useful in the treatment of women infertility with a certain level
of estrogen but being anovulatory or less ovulatory and treatment
of male infertility with luteal phase defect or few sperm; it can
also used for testing ovarian function and probing the dysfunction
of male hypothalamus (pituitary) gonadal axis. The mechanism of
action is to competitively bind to the hypothalamus estrogen
receptor binding site for taking effect. Estrogen is displaced out
from these areas, then the hypothalamus will be aware of the
apparent lack of circulating estrogen, leading to the release of
gonadotropin hormone for stimulation of follicle stimulating
hormone (FSH) and luteinizing hormone (LH) secretion with whom to
trigge the normal menstrual cycle .
Within the prescribed dose range, adverse reactions of clomiphene
citrate is not obvious, it does not affect the efficacy of
treatment with overdose and long-term medication causing a
increased adverse reactions such as the suppression of
spermatogenesis in treating male infertility.
The main adverse reactions seen in:
1.Vasomotor symptom: Some women may have hot flashes, sweating and
other menopausal syndrome, which is related to the anti-estrogen
effect of drugs; this can disappear after treatment, it can also be
alleviated by increased administration of estrogen.
2. Abdominal symptoms: bloating, a sense of falling and ovulation
pain; these symptoms are often associated with ovulation and
ovarian enlargement; It is necessary to be subject to a medical
examination to rule out the possibility of ovarian enlargement.
3. Ovarian enlargement and ovarian cysts: applying predetermined
dose rarely cause enlarged ovaries; once ovarian enlargement
occurs, discontinue treatment until restoring back into normal
ovarian size; be sure the reduce the drug dose and duration in the
next course of drug; once ovarian cysts appears, treatment should
also be discontinued immediately in order to avoid ovarian
4. Visually impairment: a few people may get blurred vision, double
vision, flashing lights, etc., The symptoms may be deteriorated
under strong light; once visual disturbances occurs, treatment
should be discontinued immediately, and patients should be subject
to eye examinations at the same time.
5. Multiple pregnancies and teratogenic: it has been already
demonstrated that clomiphene citrate can significantly increase the
incidence of multiple births, so it is necessary to perform fetal
reduction surgeries if necessary. Orally administration of
clomiphene can cause an incidence of birth defects being about
6. Other adverse reactions are rare, mostly due to the long
treatment causes, including nausea, vomiting, nervousness, fatigue,
dizziness, headache, insomnia, breast swelling and pain, increased
menstrual flow, atopic dermatitis, increased weight, polyuria, and
mild alopecia which may disappear after treatment. This product is
metabolized by the liver so that patients having a history of liver
dysfunction should not take. Patients of ovarian cysts and other
gynecological cancer should be disabled. Clomiphene citrate may
also induce abortion and teratogenic so pregnant women, should be
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