Serophene (Clomiphene Citrate) - Summary

SEROPHENE SUMMARY

Serophene^®

ClomiPHENE citrate is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1).

Serophene^® (clomiPHENE citrate tablets USP) is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy.  Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiPHENE citrate 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 clomiPHENE citrate therapy 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.)

Serophene^® (clomiPHENE citrate tablets USP) 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.  ClomiPHENE citrate should not be used in patients with ovarian enlargement except in those with polycystic ovary syndrome.  Pelvic examination is necessary prior to the first and each subsequent course of clomiPHENE citrate 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 clomiPHENE citrate 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.   ClomiPHENE citrate 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 clomiPHENE citrate 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 clomiPHENE citrate in patients with uterine fibroids due to the potential for further enlargement of the fibroids.

There are no adequate and well-controlled studies that demonstrate the effectiveness of clomiPHENE citrate 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 clomiPHENE citrate is not known.

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

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NEWS HIGHLIGHTS

Published Studies Related to Serophene (Clomiphene)

Letrozole versus combined metformin and clomiphene citrate for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome: a randomized controlled trial. [2009.09.02]
OBJECTIVE: To compare the effect of letrozole with combined metformin and clomiphene citrate (CC) for ovulation induction in CC-resistant women with polycystic ovary syndrome (PCOS)... CONCLUSION(S): Letrozole and combined metformin-CC are equally effective for inducing ovulation and achieving pregnancy in patients with CC-resistant PCOS .

Comparison of efficacy of aromatase inhibitor and clomiphene citrate in induction of ovulation in polycystic ovarian syndrome. [2009.09]
OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in induction of ovulation in polycystic ovary syndrome (PCOS)... CONCLUSION(S): Letrozole has better ovulation and PR in comparison to CC in patients with PCOS.

Clomiphene citrate or anastrozole for ovulation induction in women with polycystic ovary syndrome? A prospective controlled trial. [2009.09]
OBJECTIVE: To compare the effects of anastrozole (1 mg) and clomiphene citrate (CC; 100 mg) used for ovulation induction in women with polycystic ovary syndrome... Anastrozole may be helpful in situations in which multiple pregnancy is not desirable or the risk of ovarian hyperstimulation syndrome is high.

Extended letrozole therapy for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome: a novel protocol. [2009.07]
OBJECTIVE: To evaluate the outcome of long letrozole therapy for induction of ovulation in patients with clomiphene-resistant polycystic ovary syndrome (PCOS)...

Follicular and endocrine response to anastrozole versus clomiphene citrate administered in follicular phase to normoovulatory women: a randomized comparison. [2009.05]
OBJECTIVE: To compare the effect on follicular growth and endocrine parameters of follicular phase administration of anastrozole to healthy, normoovulatory women in doses of 1 or 5 mg, respectively, with the conventional dosing regimen for ovulation induction with clomiphene citrate (CC)... Anastrozole administration results in lower follicular phase E(2) levels.

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Clinical Trials Related to Serophene (Clomiphene)

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.

Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility [Completed]
OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group, multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in India. PATIENT(S): Fifty-five patients with anovulatory infertility were recruited. Twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles) were given CC. Both drugs were given orally on days 3-7 of menstrual cycle. INTERVENTION(S): Letrozole, CC, ovulation induction, vaginal micronized progesterone, IUI.

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.

Pregnancy in Polycystic Ovary Syndrome II [Recruiting]
The primary research hypothesis is that ovulation induction with an aromatase inhibitor (letrozole) is more likely to result in live birth than ovulation induction with a selective estrogen receptor modulator (clomiphene citrate) in infertile women with PCOS. A safety hypothesis will also be incorporated into the primary research hypothesis in which we hypothesize both treatments are equally safe for mother and child.

Secondary research hypotheses include:

1. Treatment with letrozole is more likely to result in singleton pregnancy compared to treatment with clomiphene citrate. Singleton pregnancy is defined as presence of a single intrauterine gestational sac with a single fetal pole and observable heart motion.

2. Treatment with letrozole will less likely result in a first trimester intrauterine fetal demise than treatment with clomiphene citrate. A first trimester IUFD is defined as a pregnancy that ends before 13 weeks gestation.

3. Treatment with letrozole is more likely to result in ovulation (increased ovulation rate) compared to treatment with clomiphene citrate. Ovulation is defined as a midluteal progesterone level ≥ 3 ng/mL.

4. The shortest time to pregnancy will be with letrozole.

5. Age, body mass index, SHBG, testosterone, LH, Anti-Mullerian Hormone (AMH), and degree of hirsutism and acne will be significant predictors of ovulation and conception regardless of treatment.

6. Improvement in SHBG, testosterone, AMH, and LH levels will be significant predictors of ovulation and conception regardless of treatment.

7. DNA polymorphisms in estrogen action genes will predict response to study drug.

8. Quality of Life will be better on letrozole than clomiphene.

9. Letrozole will be more cost effective at achieving singleton pregnancies than clomiphene.

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.

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