Laan E, et al. - Researchers planned this study to assess the effect of combined oral contraceptives (OCs) on sexual function, either alone or together with dehydroepiandrosterone (DHEA). This exploratory study revealed a decrease in some measures of sexual functioning in association with OC use, however, other measures remained unchanged. These effects on sexuality could be prevented with maintenance or restoration of physiological testosterone concentrations by the co-administration of DHEA to the OC. This was particularly evident in women with relatively high, but physiologic levels of free testosterone during DHEA co-administration.

Methods

• Researchers performed an exploratory randomized, double-blind, placebo-controlled, comparative, crossover study in 81 OC users.
• Subjects discontinued their OC for one cycle before they were randomized for 10 cycles to a 30 μg ethinyl estradiol (EE)/levonorgestrel (LNG) OC or a 30 μg EE/drospirenone (DRSP) OC, along with daily use of 50 mg dehydroepiandrosterone (DHEA) or placebo during 5 OC cycles before crossing over from DHEA to placebo or the reverse for another 5 cycles.
• The effect of 5 OC cycles + placebo on sexual function relative to baseline was assessed first.
• They then compared the effect of 5 OC cycles + DHEA to the OC + placebo.
• Regarding endocrine changes, results have been published separately.
• Genital response (measured by vaginal pulse amplitude [VPA]) and sexual feelings (measured by the subjective self-assessment questionnaire [SSAQ]) to self-induced erotic fantasy and visual sexual stimuli in a laboratory setting and measures of desire and arousability using a sexual function diary (SFD) were the primary efficacy outcomes of the current study.
• The Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale Revised (FSDS-R) were the secondary efficacy outcomes.

Results

• Researchers enrolled 81 women, of these, 74 women completed the study.
• They noted that 5 cycles of OC + placebo led to a marked reduction compared to baseline in four out of six SFD self-ratings of sexual desire and arousability with both OCs.
• Significant declines in the FSFI scores were observed with the LNG OC (baseline vs LNG OC + placebo: Total score, 28.7±3.7 vs 25.6±7.4; Arousal, 5.0±0.7 vs 4.5±1.4; Lubrication, 5.2±0.9 vs 4.6±1.7; Pain, 4.9±0.9 vs 4.5±1.4), however, there were no changes using the DRSP OC.
• Five cycles of OC + DHEA demonstrated no significant differences with placebo except for a significant increase in genital sensations (SSAQ) during erotic fantasy (OC + placebo vs OC + DHEA: 3.3±1.4 vs 3.6±1.5; p<.05) in the laboratory setting.
• They observed no significant changes for genital response (VPA) and the other two variables of the SSAQ assessed after visual erotic stimulus exposure.
• With DHEA, 5 out of 10 variables indicated a significant improvement using the SFD.
• With OC + DHEA compared to placebo, partner's initiative was rejected less often (OC + placebo vs OC + DHEA: 1.1±1.5 vs 0.8±1.0; p<.05).
• During DHEA co-administration, women with free testosterone levels in the upper quartile demonstrated significantly better effects on sexual arousal and desire compared to the three lower quartiles (lower vs upper quartiles: Sexual arousability: 25.0±19.8 vs 41.2±29.0; Sexual desire: 5.6±3.7 vs 9.6±8.0; Desire for sex with partner: 4.9±3.1 vs 8.6±7.4; Number of sex fantasies: 3.0±3.2 vs 5.5±4.4; all p<.05).