Efficacy and safety of intravenous pulsatile gonadotropin-releasing hormone: Lutrepulse for Injection

Article Abstract:

The gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), are secreted by the pituitary gland and stimulate the sex organs (gonads) to produce eggs or sperm. Their secretion is controlled by luteinizing hormone-releasing hormone (LHRH, also called gonadotropin-releasing hormone or GnRH), manufactured in the hypothalamus (a part of the brain) and secreted in a pulsatile fashion; thus, the release of LH into the blood also occurs in a pulsatile fashion. Part 2 of the November 1990 issue of the American Journal of Obstetrics and Gynecology presents papers from a symposium devoted to pulsatile GnRH, a method of hormone delivery that makes it possible to treat a variety of clinical disorders associated with ovulatory dysfunction. However, determination of the optimal dose and pulse frequency for each woman is difficult, and, to learn more about proper dosage, a large, multicenter study was started. Results from this study are presented. GnRH was administered in an intravenous, pulsatile form to women with primary hypothalamic amenorrhea (associated with a virtual absence of GnRH; 34 women) or secondary hypothalamic amenorrhea (amenorrhea developing later in life, with a history of menstruation; 75 women). It was pulsed every 90 minutes by means of an intravenous pump, the Lutrepulse for Injection, and subjects' blood levels of LH, FSH, estradiol (an estrogen) and progesterone (another female hormone) were tested daily. Results showed that ovulation occurred in more than 90 percent of the patients, with a slightly higher rate among women with secondary hypothalamic amenorrhea. Complications from the inserted line averaged seven percent, and mechanical failure occurred in only three cases. Pregnancy rates were 55 and 62 percent among women with primary and secondary hypothalamic amenorrhea, respectively. Eleven multiple pregnancies resulted. The pump approach appears safe and effective for the anovulatory woman. Clinicians need to learn how to determine the drug's optimal dose and should consider incorporating the intravenous pump into their practices. (Consumer Summary produced by Reliance Medical Information, Inc.)

Product/Service Evaluation, Amenorrhea, Lutrepulse for Injection (Medication)

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Introductory remarks

Article Abstract:

Gonadotropin (luteinizing hormone, LH) is a chemical secreted by the pituitary gland that stimulates the sex organs (gonads) to produce eggs or sperm; its secretion is controlled by gonadotropin-releasing hormone (GnRH or LHRH), manufactured in the hypothalamus (a part of the brain). Part 2 of the November 1990 issue of the American Journal of Obstetrics and Gynecology presents papers from a symposium held earlier in that year devoted to pulsatile GnRH, a method of hormone delivery that makes it possible to treat a variety of clinical disorders associated with gonadal dysfunction. Pulsatile GnRH is effective therapeutically, as well as being a useful research tool to investigate the ways the GnRH system functions. Thus, women with hypothalamic amenorrhea (lack of menstruation) do not have pulsatile GnRH secretion, although their pituitary-ovarian-endometrial function (the hormonal loop that results in menstruation, once initiated by the pituitary) is normal. When treated with pulsatile GnRH, many will ovulate and be able to become pregnant. The hormone is used with other agents to treat polycystic ovary syndrome, also associated with a failure to ovulate. In men, LH stimulates the secretion of testosterone (among other functions), and GnRH secretion is known to be nonpulsatile in idiopathic hypogonadotropic hypogonadism (testicular deficiency of unknown cause). Treatment with pulsatile GnRh often results in sperm production and fertility in men with this condition. The papers presented in this Journal issue focus on disorders that result from defective pulsatile secretion of GnRH by the hypothalamus. (Consumer Summary produced by Reliance Medical Information, Inc.)

Conferences, meetings and seminars

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Polycystic ovary syndrome: abnormalities and management with pulsatile gonadotropin-releasing hormone and gonadotropin-releasing hormone analogs

Article Abstract:

Gonadotropin (luteinizing hormone, LH) is a chemical secreted by the pituitary gland that stimulates the sex organs (gonads) to produce eggs or sperm; its own secretion is controlled by gonadotropin-releasing hormone (GnRH or LHRH), manufactured in the hypothalamus (a part of the brain). Part 2 of the November 1990 issue of the American Journal of Obstetrics and Gynecology presents papers from a symposium devoted to pulsatile GnRH, a method of hormone delivery that makes it possible to treat a variety of clinical disorders associated with ovarian dysfunction. One of these is polycystic ovary syndrome, a condition associated with the formation of ovarian cysts and hormonal imbalances. Patients with this condition produce excessive androgen (a male hormone) and have high LH levels; however, LH is not secreted in a normal manner. Some symptoms, such as hirsutism (excessive body hair growth) can be controlled with drugs, but such drugs usually suppress ovulation. Pulsatile GnRH may be a good option for patients with polycystic ovary syndrome who want to become pregnant; however, the method and dose administered are critical for the outcome. These aspects of drug delivery are discussed. Pulsatile GnRH is most effective when it is given at a dose of five micrograms every 60 minutes after pretreatment for several weeks with a GnRH analog: this causes the patient to become temporarily hypogonadotropic, i.e. to have reduced levels of gonadotropin. In this state of reduced LH secretion, pulsatile GnRH seems to be maximally effective. (Consumer Summary produced by Reliance Medical Information, Inc.)

Control, Stein-Leventhal syndrome, Polycystic ovary syndrome

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