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Pergonal

Clinical Pharmacology
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Clinical Pharmacology

Pergonal

Serum LH concentrations upon multiple dose SC or IM Repronex are low and variable. No recognizable trend in the increase in serum LH concentrations from SC or IM 150 to 450 IU/day Repronex doses was observed. After the 6th dose of SC or IM 150 IU/day Repronex, the range of baseline-corrected serum LH concentrations is 0 to 3.2 mIU/mL for both routes of administration.

Absorption: The geometric mean of FSH Cmax and AUC0-¥ upon single dose SC administration of menotropins is 5.62 mIU/mL and 385.2 mIU· h/mL, respectively; the corresponding geometric median of FSH tmax is 12 hours. The geometric mean of FSH Cmax and AUC0-¥ upon single dose IM administration of menotropins is 4.15 mIU/mL and 320.1 mIU· h/mL, respectively; the corresponding geometric median of FSH tmax is 18 hours.

Distribution: Human tissue or organ distribution of FSH and LH have not been studied for Repronex.

Metabolism: Metabolism of FSH and LH have not been studied for Repronex in humans.

Excretion: The mean elimination half-lives of FSH upon single dose SC and IM administration of menotropins are 53.7 and 59.2 hours, respectively.

Pediatric Populations: Repronex is not used in pediatric populations.

Geriatric Populations: Repronex is not used in geriatric populations.

Special Populations: The safety and efficacy of Repronex in renal and hepatic insufficiency have not been studied.

Drug Interactions: No drug/drug interaction studies have been conducted for Repronex in humans.

CLINICAL STUDIES

Efficacy results for two randomized, active controlled, multi-center studies in in vitro fertilization (IVF) and ovulation induction (OI) are summarized in tables 2 and 3. The patients underwent pituitary suppression with a GnRH agonist before starting Repronex® administration. The first study evaluated 186 patients undergoing IVF who received 225 IU Repronex® daily for 5 days. This was followed by individual titration of the dose from 75 to 450 IU daily based on ultrasound and estradiol (E2) levels. The total duration of dosing did not exceed 12 days. The second study evaluated 108 patients who received 150 IU Repronex® daily for 5 days. This was followed by individual titration of the dose from 75 to 450 IU daily based on ultrasound and estradiol (E2) levels. The total duration of dosing did not exceed 12 days.

Table 2: Efficacy Outcomes by Treatment Group for IVF (one cycle of treatment)

Parameter

Repronex IM

N= 65

Repronex SC

N= 60
Total oocytes Retrieved

13.6

12.7
Mature oocytes Retrieved

9.4

8.6
Pts w/ oocyte Retrieval (%)
Brand Name: Pergonal
Generic Name: Menotropins
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Repronex is sometimes used to treat infertility problems. Find additional health information on infertility and other reproductive treatment options at WebMD.com.