HPGA Normalization Protocol After Androgen Treatment
N Vergel, AL Hodge, MC Scally
Program for Wellness Restoration, PoWeR

Objective Results Discussion

To develop an approach to cycle androgens that would result in significant changes in body composition and accelerate the normalization of the hypothalamic pituitary gonadal axis (HPGA) after cessation of androgens.

Methods

An uncontrolled study of 19 HIV-negative eugonadal men, ages 23 – 57 years, administered testosterone cypionate and nandrolone decanoate for 12 weeks, and then were treated simultaneously with a combined regimen of human chorionic gonadotropin (hCG) (2500 IU/QODx16d), clomiphene citrate (50 mg PO BID x 30d) and tamoxifen (20 mg PO QD x 45d), to restore the HPGA.

Results

Mean FFM by DEXA increased from 64.1 to 69.8 kg (p<.001); percent body fat decreased from 23.6 to 20.9 (p<.01); strength increased significantly from 357.4 lb to 406.4 lb (p=.02). No significant changes in serum chemistries and liver function tests were found. HDL-C decreased from a mean value of 44.3 to 38.0 (p=.02). Mean values for luteinizing hormone (LH) and total testosterone (T) were 4.5 and 460, respectively prior to androgen treatment. At the conclusion of the 12-week treatment with androgens the mean LH <0.7 (p<.001) and total testosterone was 1568 (p<.001). The mean values after treatment with the combined regimen were LH=6.2 and testosterone=458.

Discussion

The use of androgens has been reported to improve lean body mass, strength, sexual function, and mood accompanied by side effects caused by continuous uninterrupted use of these compounds (polycythemia, testicular atrophy, hypertension, liver dysfunction [oral androgens] and alopecia.) Androgen-induced HPGA suppression causes a severe hypogonadal state in most patients that often require an extensive period of considerable duration for normalization. This prevents most if not all individuals from cycling off these medications due to the adverse impact of this state on their previously gained LBM and quality of life. The protocol of hCG-clomiphene-tamoxifen was successful in restoring the HPGA within 45 days after androgen cessation. Further controlled studies are needed to determine if these results can be duplicated in HIV positive subjects.