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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.


See all Serophene indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Serophene (Clomiphene)

Effect of estradiol valerate on endometrium thickness during clomiphene citrate-stimulated ovulation. [2014]
CONCLUSIONS: We concluded that the addition of 6 mg/day EV following the CC

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)...

more studies >>

Clinical Trials Related to Serophene (Clomiphene)

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

Traditional Clomiphene Citrate Administration vs. Stair-step Approach [Recruiting]
The purpose of this study is to compare the length of time to achieve ovulation and pregnancy with a traditional protocol administration of clomiphene citrate versus a stair step administration. Our hypothesis is by using a stair-step approach in which a period is not induced between administrations of escalating doses of clomiphene citrate, the time to ovulation and pregnancy may be reduced.

Clomifene Citrate as First Line Treatment in in Vitro Fertilization Cycles for Patients With Lower Ovarian Reserve [Completed]
Women with compromised ovarian reserve requiring in vitro fertilization (IVF) still represent a demanding challenge for clinicians. It has classically been claimed that using higher dosages of gonadotropins may overcome the scarce ovarian responsiveness to hyper-simulation and increase the chances of success. However, scientific evidence supporting this view is scanty and costs are inevitably much higher. In this study, the investigators hypothesized that similar chances of pregnancy may be achieved with a mild stimulation using exclusively Clomiphene citrate (CC).

Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism [Not yet recruiting]
Hypothesis: Prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.

Clomiphene Citrate Versus Tamoxifen for Ovulation Induction in PCOs [Recruiting]
Comparison between Clomiphene citrate and Tamoxifen for induction of ovulation in women with PCOS.

more trials >>

Reports of Suspected Serophene (Clomiphene) Side Effects

Foetal Exposure During Pregnancy (2)Potter's Syndrome (2)Hypersensitivity (1)Drug Ineffective (1)Abortion Spontaneous (1)Abdominal Discomfort (1)Dizziness (1)Oestrogen Receptor Assay Positive (1)Intracranial Meningioma Malignant (1)Nausea (1)more >>


Page last updated: 2014-11-30

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