Duration of Clomid Treatment
Clomid should not be used for more than 6 treatment cycles total, with most patients who will respond doing so within the first 3 cycles. 1
FDA-Approved Treatment Duration
- The FDA label explicitly states that long-term cyclic therapy is not recommended beyond a total of about 6 cycles. 1
- If ovulation does not occur after 3 courses of therapy, further treatment with clomiphene citrate is not recommended and the patient should be reevaluated. 1
- If 3 ovulatory responses occur but pregnancy has not been achieved, further treatment is not recommended. 1
Standard Dosing Protocol
- Treatment should begin with 50 mg daily for 5 days, starting on or about day 5 of the menstrual cycle. 1
- If ovulation does not occur after the first course, increase to 100 mg daily for 5 days in the second course, which may be started as early as 30 days after the previous cycle. 1
- Increasing the dosage or duration beyond 100 mg/day for 5 days is not recommended. 1
- The majority of patients who will ovulate do so after the first course of therapy. 1
Evidence Supporting Limited Duration
- In a large randomized trial of 626 women with PCOS, clomiphene was used for up to 6 months, achieving a 22.5% live-birth rate with clomiphene alone and 26.8% with combination therapy. 2
- Among women who achieved pregnancy with clomiphene in one study, 87.5% conceived within 6 months of treatment. 3
- The conception rate among ovulating patients was 39.5% with clomiphene alone in a major multicenter trial. 2
Critical Safety Considerations
- The therapeutic objective must be balanced with potential risks, particularly ovarian hyperstimulation syndrome in patients with PCOS. 1
- Patients must be carefully evaluated to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle. 1
- If menses does not occur after an ovulatory response, the patient should be reevaluated before continuing treatment. 1