OR19-6 Testosterone Dose-Response Relationships in Surgically Menopausal Women: Effects on Sexual Function in a Randomized Trial

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: OR19-Female Reproductive Endocrinology
Clinical
Sunday, June 16, 2013: 11:15 AM-12:45 PM
Presentation Start Time: 12:30 PM
Room 102 (Moscone Center)
Grace Huang*1, Shehzad Sultan Basaria1, Thomas G Travison1, Matthew Ho2, Maithili Davda1, Norman Alan Mazer3, Renee Miciek1, Philip E Knapp1, Lauren Elizabeth Collins1, Monica Ursino1, Erica Appleman1, Connie Dzekov2, Helene Stroh1, Thomas W Storer1 and Shalender Bhasin1
1Boston University Medical Center, Boston, MA, 2Charles R. Drew University of Medicine and Science, Los Angeles, CA, 3F.Hoffmann-La Roche Ltd., Basel, Switzerland
Background: Surgical menopause is associated with significant decline in serum testosterone levels and increased risk for sexual dysfunction despite estrogen replacement. Limited data suggest that testosterone replacement in women improves sexual function.  However, testosterone dose-response relationships in these women have not been established.

Objective: To determine the dose-dependent effects of graded doses of testosterone on sexual function in surgically menopausal women.

Methods: 71 surgically menopausal women received a standardized transdermal estradiol regimen during the 12-week run-in period, and were then randomized to receive weekly IM injections of placebo (n=15), or 3 (n=14), 6.25 (n=14), 12.5 (n=15) or 25 mg (n=13) testosterone enanthate for 24 weeks. Total and free testosterone levels were measured by LC-MS/MS and equilibrium dialysis, respectively.  Sexual function was measured by the Brief Index of Sexual Functioning for Women (BISF-W) and a weekly Sexual Activity Log (SAL). Mood and well-being were assessed using the Psychological General Well-Being Index (PGWBI).  

Results: 71 women were randomized. At baseline, mean age was 53 yrs, BMI 30 kg/m², total testosterone 13.7 ng/dl and free testosterone 2.2 pg/ml. On-treatment nadir testosterone concentrations were 14, 78, 105, 130 and 211 ng/dl at the 0, 3, 6.25, 12.5 and 25-mg doses, respectively. Changes in composite BISF-W scores, thoughts-desire, arousal, and frequency of sexual activity were significantly related to increases in free testosterone concentrations (p<0.05).  The changes in sexual thoughts-desire and frequency of sexual activity were significantly greater in women assigned to the 25-mg group than in those assigned to placebo group (p< 0.01) but not at the lower dose groups. Sexual activity increased by 2.7 encounters per week in the 25-mg dose group and changes were significantly related to increases in free testosterone concentrations (p<0.01). PGWBI composite and vitality domain scores significantly increased at the 12.5mg and 25mg dose-group, respectively when compared to placebo (p<0.05). Frequency of androgenic adverse events was low.

Conclusion: Testosterone administration in surgically menopausal women for 24-weeks was associated with dose and concentration-dependent gains in several domains of sexual function. Clinically meaningful improvements were observed only at supraphysiologic testosterone doses and concentrations.  Long-term trials are needed to weigh improvements in these outcomes against potential long-term adverse effects.

Nothing to Disclose: GH, SSB, TGT, MH, MD, NAM, RM, PEK, LEC, MU, EA, CD, HS, TWS, SB

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm

Sources of Research Support: National Institute of Child Health and Human Development Grant NCT00494208
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