Clomid (Clomiphene Citrate) - Summary

CLOMID SUMMARY

CLOMID^®
(clomiphene citrate tablets USP)

CLOMID (clomiphene citrate tablets USP) is an orally administered, nonsteroidal, ovulatory stimulant.

CLOMID is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning CLOMID therapy. Those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology.

Properly timed coitus in relationship to ovulation is important. A basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred. Once ovulation has been established, each course of CLOMID should be started on or about the 5th day of the cycle. Long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles). (See DOSAGE AND ADMINISTRATION and PRECAUTIONS.)

CLOMID is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below (see CONTRAINDICATIONS):

1. Patients who are not pregnant.
2. Patients without ovarian cysts. CLOMID should not be used in patients with ovarian enlargement except those with polycystic ovary syndrome. Pelvic examination is necessary prior to the first and each subsequent course of CLOMID treatment.
3. Patients without abnormal vaginal bleeding. If abnormal vaginal bleeding is present, the patient should be carefully evaluated to ensure that neoplastic lesions are not present.
4. Patients with normal liver function.

In addition, patients selected for CLOMID therapy should be evaluated in regard to the following:

1. Estrogen Levels. Patients should have adequate levels of endogenous estrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary estrogen, or from bleeding in response to progesterone). Reduced estrogen levels, while less favorable, do not preclude successful therapy.
2. Primary Pituitary or Ovarian Failure. CLOMID therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure.
3. Endometriosis and Endometrial Carcinoma. The incidence of endometriosis and endometrial carcinoma increases with age as does the incidence of ovulatory disorders. Endometrial biopsy should always be performed prior to CLOMID therapy in this population.
4. Other Impediments to Pregnancy. Impediments to pregnancy can include thyroid disorders, adrenal disorders, hyperprolactinemia, and male factor infertility.
5. Uterine Fibroids. Caution should be exercised when using CLOMID in patients with uterine fibroids due to the potential for further enlargement of the fibroids.

There are no adequate or well-controlled studies that demonstrate the effectiveness of CLOMID in the treatment of male infertility. In addition, testicular tumors and gynecomastia have been reported in males using clomiphene. The cause and effect relationship between reports of testicular tumors and the administration of CLOMID is not known.

Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (ie, CLOMID in conjunction with other ovulation-inducing drugs). Similarly, there is no standard CLOMID regimen for ovulation induction in in vitro fertilization programs to produce ova for fertilization and reintroduction. Therefore, CLOMID is not recommended for these uses.

See all Clomid indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Clomid (Clomiphene)

Clomiphene citrate versus tamoxifen for ovulation induction in women with PCOS: a prospective randomized trial. [2011.11]
OBJECTIVE: To reevaluate the efficacy of induction of ovulation with CC versus TMX in a group of anovulatory subfertile women with PCOS in a randomized controlled trial... CONCLUSIONS: Clomiphene citrate is more successful than tamoxifen as a first line therapy for ovulation induction in women with PCOS. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.

Laparoscopic ovarian diathermy after clomiphene failure in polycystic ovary syndrome: is it worthwhile? A randomized controlled trial. [2011.11]
PURPOSE: Laparoscopic ovarian diathermy (LOD) represents a successful treatment option for women with clomiphene citrate (CC)-resistant polycystic ovary syndrome (PCOS). However, in case of CC failure PCOS, LOD offers several theoretical advantages. This study was conducted to compare the efficacy of LOD versus continuation of CC up to six further cycles in PCOS patients who failed to achieve pregnancy despite the previous successful CC induced ovulation... CONCLUSIONS: LOD during the 6 months follow-up period and CC for up to six further cycles are equally effective for achieving pregnancy in CC failure PCOS patients.

A randomized controlled trial of the effect of rosiglitazone and clomiphene citrate versus clomiphene citrate alone in overweight/obese women with polycystic ovary syndrome. [2011.10.04]
Background: In women suffering from polycystic ovary syndrome, correction of hyperinsulinemia results in enhanced responsiveness to ovulation induction agents. The effect of rosiglitazone was investigated on ovulation induction in obese women with PCOS... Conclusions: Short term administration of rosiglitazone to overweight and obese PCOS women results in enhancement of CC induced ovulation as well as improvement of insulin sensitivity.

Clomiphene citrate versus letrozole: molecular analysis of the endometrium in women with polycystic ovary syndrome. [2011.10]
OBJECTIVE: To compare the effect of clomiphene citrate (CC) and letrozole on endometrial receptivity in women with polycystic ovary syndrome (PCOS)...

Prospective, randomized comparison between raloxifene and clomiphene citrate for ovulation induction in polycystic ovary syndrome. [2011.09]
OBJECTIVE: To compare the ovulation rate between raloxifene and clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS)...

more studies >>

Clinical Trials Related to Clomid (Clomiphene)

Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene [Recruiting]

Comparison of Clomiphene Citrate and Gonadotropins in Ovulation Induction Cycles [Recruiting]
The purpose of the present study is to analyse prospectively if highly purified hMG compared with increased dose of clomiphene citrate has different outcomes in folliculogenesis in ovulation induction cycles.

Tamoxifen Compared With Clomiphene Citrate for Women Who Had Thin Endometrium Women Under Clomiphene in a Previous Cycle [Recruiting]
About 10-15% of all couples attempting to conceive will not become pregnant within one year. Among those, the majority will have ovulatory dysfunction, mild male infertility or unexplained infertility. The traditional first line therapy for those couples is ovulation induction or superovulation using clomiphene citrate. Probably due to anti-estrogenic effects of this agent will, some patients will have a thin endometrium as measured by sonography at the time of ovulation. This phenomenon may be associated with a lower chance to conceive. Tamoxifen is a similar molecule that has been used to clomiphene citrate that has been shown to be equally effective to clomiphene in ovulation induction. Preliminary observations showed that tamoxifen does not cause a negative effect on the endometrium as compared with clomiphene, and may increase the chance to conceive in those patients who have a thin endometrium under clomiphene.

Clomiphene Citrate (CC) Co-treatment With HP Urinary FSH vs HP Urinary FSH in CC-resistant PCOS [Recruiting]
To test whether adding small doses of HP urinary FSH to standard regimen of clomiphene citrate in clomiphene resistant PCOS well yield better results in terms of better ovulation rate,lower follicle number, less consumption of HP urinary FSH,lower treatment cost , better pregnancy rate, lower multiple pregnancy rates compared with the exclusive use of HP urinary FSH in these cases.

Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome [Recruiting]
The Polycystic Ovarian Syndrome (PCOS) is a common disorder related to ovulation problems. Clomiphene citrate (CC) is the drug of first choice for this condition. Nevertheless, CC has a detrimental effect over uterine receptivity.

Raloxifene is a Selective Estrogen Receptor Modulator, that does not have a detrimental effect over the endometrium, and also increase the serum levels of FSH, thus, inducting ovulation.

The objective of this study is to compare the ovulation rate in PCOS patients between clomiphene citrate and raloxifene in a double blind randomized trial.

more trials >>

Reports of Suspected Clomid (Clomiphene) Side Effects

Drug Withdrawal Syndrome Neonatal (2),  Maternal Drugs Affecting Foetus (1),  Pain (1),  Headache (1),  Pyrexia (1),  Abortion Spontaneous (1),  Anovulatory Cycle (1),  Erectile Dysfunction (1),  Menstruation Irregular (1),  Blood Follicle Stimulating Hormone Decreased (1), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Clomid review by 41 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		female problems, trying to get pregnant, ovulation
Dosage & duration:		50 mg once daily for five days taken 1 a day for the period of 3 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		One thing that Clomid does is aids in maturing the eggs.. many women ovulate, but the eggs that are released aren't reaching "full maturity" beforehand. An egg that isn't "mature" usually cannot be fertilized...this was part of my case (Clomid certainly does other things to aid in getting pregnant and ovulating, etc). I took Clomid for YEARS. Conceived my daughter on Clomid the first month (she's now 13 yrs old), but also took it for years after that with no luck....eventually got pg with no outside help.
Side effects:		Enlargement of the ovaries -- up to 13.6 percent of women Hot flashes -- up to 10.4 percent Abdominal (stomach) or pelvic pain or bloating -- up to 5.5 percent Upset stomach (nausea) or vomiting -- up to 2.2 percent Breast pain -- up to 2.1 percent Headache -- up to 1.3 percent (see Clomid and Migraines) Abnormal menstrual bleeding, including spotting between periods or long, heavy periods -- up to 1.3 percent.
Comments:		My starting Clomid dose was 50 mg once daily for five days. The Clomid dosage was increased to 100 mg and ovulation occured. My doctor will helped me to determine that ovulation has occurred using an ultrasound.

Clomid review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		unexplained infertility
Dosage & duration:		50 mg taken once per day for the period of 5 days per month
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Intended to produce more follicles to increase chances of conception, in combination with intrauterine insemination. I had 5 rounds of treatment, though I'm not sure why the doctor chose to try this many times when none of the early tries were successful. Some stimulation occurred - 7-10 follicles were stimulated with each treatment - but conception did not occur.
Side effects:		Visual disturbances (flashing light effects, blurring), mood swings, fluid retention.
Comments:		Clomid was given on days 3-7 of the menstrual cycle, one 50 mg pill by mouth per day, at the same time each day. Follicle progress was subsequently tracked via ultrasound. Side effects were minimal with the first round of treatment, more severe with the 2nd onward. I have no known allergies or sensitivities to other medications, other than topical iodine.

Clomid review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		infertility
Dosage & duration:		150 mg taken 5 days per month for the period of 3 month
Other conditions:		obesity
Other drugs taken:		none
		Reported Results
Benefits:		Clomiphene citrate or clomid is used for treatments of fertiliy in women. It triggers the ovaries to ripen more ovuls and to invrease the change of conceiving.
Side effects:		bluuring vision, moodiness, depression, panic attacks, weight gain, skin problems
Comments:		Starting with the first day of menstruation as day 1, a daily dose of 150 mg is taken from day 5 to 9 of the monthly cycle. Chlomiphene citrate does first suppress estrogen in the womens body therefore the body reacts with an increased effort to build estrogen. After day 9 the increased effort to build estrogen comes effectiv in the ovaries producing more ovuls.