The present invention provides iraws-clomiphene and pharmaceutically acceptable salts and solvates thereof, characterized in that trans -clomiphene is in particulate form having a specific size range. The invention is also directed to pharmaceutical compositions comprising or formulated using trans -clomiphene or pharmaceutically acceptable satls and solvates having a specified size range and their use in treating disorders including secondary hypogonadism, type 2 diabetes, elevated
cholesterol, elevated triglycerides,
wasting,
lipodystrophy, female and
male infertility,
benign prostate hypertrophy,
prostate cancer,
breast cancer,
ovarian cancer and
endometrial cancer.