Pregnancy Category C

Uses. Experiments have shown that testolactone can produce substantial reductions in size of tumors, although such results are not invariable. Medical practitioners mainly use this drug to ease suffering from breast cancer in older female patients and in younger women who no longer have functioning ovaries. The drug may permanently reduce the amount of estrogen hormones in a woman's body; such hormones affect pregnancy and female physical characteristics. Unlike other anabolic steroids, testolactone seems to have no masculinizing effect on women. Clinical experimentation using testolactone as part of the regimen against a juvenile adrenal gland disorder found no adverse effect on children's bone growth, in contrast to most anabolic steroids' ability to prematurely halt bone growth in young people. Testolactone has had success in treating premature male puberty, in restoring normal growth characteristics, and in improving young men's mood—all without harming bone development. The substance has also reduced abnormal enlargement of breasts that some males experience during adolescence. Although the drug is not recommended for women who have yet to pass through menopause, tes-tolactone has seen experimental success in controlling premature puberty among girls suffering from McCune-Albright syndrome (a disease also involving bone and skin abnormalities). In rat experiments the drug had no apparent effect on fertility, but in humans the substance has been used to improve male fertility with mixed success. Testolactone has also been given to counteract human male sexual dysfunction caused by some epilepsy therapy. Experimental use against enlarged prostate has had promising results.

Drawbacks. Unwanted effects are described as uncommon but can include headache, skin rash, tingling, nausea, constipation or diarrhea, and abdominal discomfort. By elevating amounts of calcium in the blood, the drug can make a person become confused. Temporary hair loss was reported with two patients who were also taking a corticosteroid.

Abuse factors. Not enough scientific information to report about tolerance, dependence, withdrawal, or addiction.

Drug interactions. Testolactone may promote bleeding if a person is also taking anti-blood clot medicine.

Cancer. Testolactone's potential for causing cancer is unknown. Pregnancy. In rat experiments at doses far higher than humans normally receive, the drug increased the amount of fetal malformations and deaths. No birth defects were found when pregnant rabbits received over seven times the normal human dose. The drug is not designed for pregnant women, and impact on human pregnancy is unknown. Whether the drug passes into human milk is unknown.

Additional scientific information may be found in:

Goldenberg, I.S., et al. "Combined Androgen and Antimetabolite Therapy of Advanced

Female Breast Cancer." Cancer 36 (1975): 308-10. Howards, S.S. "Treatment of Male Infertility." New England Journal of Medicine 332 (1995): 312-17.

Laue, L., et al. "Treatment of Familial Male Precocious Puberty with Spironolactone and Testolactone." New England Journal of Medicine 320 (1989): 496-502. "Testolactone Aqueous Suspension (Teslac)." Clinical Pharmacology and Therapeutics 11 (1970): 302-6.

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