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General Considerations: The work-up and treatment of candidates for Clomifene citrate therapy should be supervised by physicians experienced in management of gynecologic or endocrine disorders. Patients should be chosen for therapy with Clomifene citrate only after careful diagnostic evaluation. The plan of therapy should be outlined in advance. Impediments to achieving the goal of therapy must be excluded or adequately treated before giving Clomifene citrate.
Many patients will respond to 50 mg daily for 5 days. In the determination of a recommended starting dose schedule, efficacy must be balanced against potential adverse effects. For example, the data available so far suggest that ovulation and pregnancy are slightly more attainable on 100 mg/day for 5 days than on 50 mg/day for 5 days.
As the dosage is increased, however, ovarian hyperstimulation and other adverse affects may be expected to increase. Furthermore, although the data do not yet establish a relationship between dosage and multiple births, it would seem reasonable on pharmacologic grounds that such a relationship does exist.
For these reasons, it would seem prudent to begin the treatment of the usual patient with a lower dose, 50 mg daily for 5 days, and to increase the dose only in those patients who do not respond to the first course. Special care with lower dosage or duration of treatment course is particularly recommended if unusual sensitivity to pituitary gonadotropin is suspected, such as in patients with polycystic ovary syndrome.
Recommended Dosage: The recommended dose for the first course of Clomifene citrate is 50 mg daily for 5 days.
Therapy may be started at any time in the patient who has had no recent uterine bleeding. If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs before therapy, the regimen of 50 mg daily for 5 days should be started on or about the fifth day of the cycle. When ovulation occurs at this dosage, there is no advantage to increasing the dose in subsequent cycles of treatment.
If ovulation appears not to have occurred after the first course of therapy, a second course of 100 mg daily (two 50 mg tablets given as a single daily dose) for 5 days should be given. This course may be started as early as 30 days after the previous one.
Increase of the dosage or duration of therapy beyond 100 mg/day for 5 days should not be undertaken.
The majority of patients who are going to respond will respond to the first course of therapy, and 3 courses should constitute an adequate therapeutic trial. If ovulatory menses have not yet occurred, the diagnosis should be re-evaluated. Treatment beyond this is not recommended in the patient who does not exhibit evidence of ovulation.
Pregnancy: The importance of properly timed coitus cannot be overemphasized. For regularity of cyclic ovulatory response it is also important that each course of Clomifene citrate be started on or about the fifth cycle day, once ovulation has been established.
As with other therapeutic modalities, Clomifene citrate therapy follows the rule of diminishing returns, such that likelihood of conception diminishes with each succeeding course of therapy. Before starting treatment, patients should be advised of the possibility of multiple pregnancy and its potential hazards if conception occurs in relationship to Clomifene citrate therapy.
Long-term cyclic therapy not recommended: Since the relative safety of long term cyclic therapy has not yet been conclusively demonstrated and since the majority of patients will ovulate following 3 courses long-term cyclic therapy is not recommended, i.e. beyond a total of about 6 cycles (including 3 ovulatory cycles).
Route of Administration: Oral.
