Serophene (clomiphene citrate) is a first-line oral fertility medication specifically designed to stimulate ovulation in women experiencing anovulatory disorders. As a selective estrogen receptor modulator (SERM), it works by blocking estrogen receptors in the hypothalamus, prompting increased secretion of gonadotropin-releasing hormone (GnRH). This cascade stimulates the pituitary gland to release follicle-stimulating hormone (FSH) and luteinizing hormone (LH), ultimately promoting follicular development and maturation. With decades of clinical use and extensive research supporting its efficacy, Serophene remains a cornerstone treatment in reproductive endocrinology for appropriately selected patients.

Features

• Active ingredient: Clomiphene citrate 50 mg
• Administration: Oral tablet
• Mechanism: Selective estrogen receptor modulator (SERM)
• Bioavailability: Approximately 85-90% following oral administration
• Half-life: 5-7 days
• Metabolism: Hepatic via cytochrome P450 system
• Excretion: Primarily fecal (approximately 42-48%), with urinary elimination of metabolites
• Pregnancy category: X (contraindicated in pregnancy)
• FDA-approved since 1967 for ovulation induction

Benefits

• Effectively induces ovulation in approximately 80% of appropriately selected anovulatory women
• Restores regular ovulatory cycles in women with polycystic ovary syndrome (PCOS)
• Non-invasive oral administration compared to injectable fertility medications
• Well-established safety profile with decades of clinical use
• Cost-effective first-line treatment option for ovulation induction
• Enables timed intercourse or intrauterine insemination (IUI) cycles

Common use

Serophene is primarily indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. The most common applications include management of polycystic ovary syndrome (PCOS), hypothalamic amenorrhea, and other anovulatory conditions. Specialists typically prescribe Serophene for patients with demonstrated estrogen production, as evidenced by progestin-induced withdrawal bleeding. The medication is generally initiated after thorough evaluation excludes other causes of infertility, including male factor infertility, tubal obstruction, and uterine abnormalities. Treatment is usually limited to 3-6 cycles due to decreasing efficacy beyond this timeframe and potential endometrial effects.

Dosage and direction

The initial recommended dosage is 50 mg (one tablet) daily for 5 days, beginning on day 3, 4, or 5 of the menstrual cycle following spontaneous or progestin-induced bleeding. Treatment should be started at the lowest effective dose to minimize side effects and multiple gestation risk. If ovulation does not occur at the initial dose, the dosage may be increased to 100 mg daily for 5 days in subsequent cycles. Doses exceeding 100 mg daily are not recommended due to decreased efficacy and increased adverse effects. Maximum recommended daily dose is 150 mg. Ultrasound monitoring is advised to assess follicular development and prevent ovarian hyperstimulation syndrome (OHSS). Timing of intercourse or insemination is typically recommended 5-10 days after the last dose, based on ovulation prediction methods.

Precautions

Patients should undergo comprehensive fertility evaluation before initiating therapy, including assessment of ovarian reserve, tubal patency, and semen analysis. Thyroid function and prolactin levels should be normalized before treatment. Regular monitoring via transvaginal ultrasound is essential to assess follicular development and prevent multiple gestation pregnancies, which occur in approximately 5-8% of cycles. Endometrial thickness should be monitored, as clomiphene may have anti-estrogenic effects on the endometrium. Ovarian size should be assessed before each treatment cycle, and therapy should be withheld if ovarian cysts are present. Visual symptoms should be promptly reported, as they may indicate serious complications. Treatment should be discontinued after 3-6 ovulatory cycles if pregnancy does not occur.

Contraindications

Serophene is contraindicated in patients with known hypersensitivity to clomiphene citrate or any component of the formulation. It must not be used during pregnancy (Category X) or in women with undiagnosed abnormal genital bleeding. Patients with liver disease or a history of liver dysfunction should avoid this medication due to hepatic metabolism. Ovarian cysts not associated with polycystic ovary syndrome represent another contraindication. The medication is not indicated in patients with primary pituitary or ovarian failure. Women with uncontrolled thyroid or adrenal dysfunction should not use Serophene until these conditions are properly managed.

Possible side effects

The most common adverse effects include vasomotor flashes (10-20%), abdominal discomfort (5-7%), and breast tenderness (2-5%). Ovarian enlargement occurs in approximately 5-10% of patients, typically resolving spontaneously after treatment cessation. Visual disturbances such as blurring, spots, or flashes affect 1-2% of patients and necessitate immediate discontinuation. Less frequent side effects include nausea, vomiting, nervousness, insomnia, headache, and dizziness. Multiple gestation pregnancy occurs in 5-8% of pregnancies, with twins being most common. Serious but rare complications include ovarian hyperstimulation syndrome (OHSS), which may present with rapid weight gain, abdominal pain, and respiratory distress.

Drug interaction

Serophene may interact with anticoagulants, potentially enhancing their effects. Concomitant use with other fertility medications, particularly gonadotropins, significantly increases the risk of ovarian hyperstimulation syndrome. Drugs that induce liver enzymes (e.g., rifampin, carbamazepine) may decrease clomiphene efficacy, while inhibitors of CYP450 enzymes may increase serum levels. Danazol may inhibit ovulation induced by clomiphene. Thyroid medications may require adjustment during treatment. Herbal supplements with estrogenic effects (e.g., black cohosh, soy isoflavones) may interfere with Serophene’s mechanism of action. Always inform your physician of all medications and supplements before beginning treatment.

Missed dose

If a dose is missed, take it as soon as remembered unless it is almost time for the next dose. Do not double the dose to make up for a missed one. Missing doses may compromise treatment efficacy for that cycle. If multiple doses are missed, contact your healthcare provider for guidance. Consistent timing of administration is recommended to maintain stable drug levels, though the long half-life of clomiphene citrate provides some flexibility. Documentation of missed doses is important for interpreting treatment response and planning future cycles.

Overdose

Symptoms of overdose may include nausea, vomiting, vasomotor flushes, visual disturbances, abdominal pain, and ovarian enlargement. In case of suspected overdose, seek immediate medical attention. Treatment is supportive and symptomatic, as there is no specific antidote. Gastric lavage may be considered if ingestion occurred recently. Medical monitoring should include pelvic examination and ultrasound to assess ovarian size. Hospitalization may be necessary for severe cases involving significant ovarian enlargement or symptoms of hyperstimulation syndrome. The long half-life necessitates extended observation in overdose situations.

Storage

Store at controlled room temperature (20-25°C or 68-77°F) in the original container. Protect from light and moisture. Keep tightly closed and out of reach of children. Do not use if the packaging is damaged or tablets appear discolored. Proper disposal of unused medication is essential, particularly to prevent accidental exposure during pregnancy. Do not flush medications down the toilet or pour them into drains unless specifically instructed to do so.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Serophene should be used only under the supervision of a qualified healthcare provider specializing in reproductive medicine. Individual response to therapy may vary, and treatment should be tailored to specific medical circumstances. The prescribing physician should thoroughly discuss potential risks and benefits before initiating treatment. Regular monitoring is essential throughout therapy to ensure safety and optimize outcomes.

Reviews

Clinical studies demonstrate ovulation rates of 70-80% in appropriately selected patients, with cumulative pregnancy rates of approximately 30-40% over 3-6 treatment cycles. Systematic reviews confirm Serophene’s efficacy as first-line treatment for anovulatory infertility, particularly in PCOS patients. Patient satisfaction surveys indicate appreciation for the oral administration route compared to injectable alternatives, though some report concerns about side effects, particularly vasomotor symptoms. Long-term follow-up studies show no increased risk of ovarian cancer with proper use limited to 6 cycles or less. The American Society for Reproductive Medicine guidelines continue to recommend clomiphene citrate as first-line ovulation induction therapy for most anovulatory women.