Sexual function in women on estradiol or venlafaxine for hot flushes: a randomized controlled trial

Obstet Gynecol. 2014 Aug;124(2 Pt 1):233-241. doi: 10.1097/AOG.0000000000000386.

Abstract

Objective: To evaluate sexual function in midlife women taking low-dose oral estradiol or venlafaxine for hot flushes.

Methods: In an 8-week randomized controlled trial among women aged 40-62 years, sexual function was compared between 0.5 mg oral estradiol per day or 75 mg venlafaxine per day (both compared with a placebo). Measures included composite and six domain scores from the Female Sexual Function Index and sexually related personal distress.

Results: Participants were aged 54.6 years (standard deviation [SD] 3.8) years, 59% white, with 8.1 (SD 5.3) daily hot flushes. Median composite baseline Female Sexual Function Index score was 16.3 (SD 11.9, n=256) for all women and 21.7 (SD 9.3, n=198) among sexually active women. Composite mean Female Sexual Function Index change from baseline to week 8 was 1.4 (95% confidence interval [CI] -0.4 to 3.2) for estradiol, 1.1 (95% CI -0.5 to 2.7) for venlafaxine, and -0.3 (95% CI -1.6 to 1.0) for placebo. Composite Female Sexual Function Index and sexually related distress change from baseline did not differ between estradiol and placebo (P=.38, P=.30) or venlafaxine and placebo (P=.79, P=.48). Among sexually active women, Female Sexual Function Index domain score change from baseline differences (active compared with placebo) in desire was 0.3 (95% CI 0.0-0.6) for estradiol, -0.6 (95% CI -1.2 to 0.0) in orgasm for venlafaxine, and 0.9 (95% CI 0.2-1.6) in penetration pain for venlafaxine. No women reported adverse events related to sexual dysfunction.

Conclusion: Overall sexual function among nondepressed midlife women experiencing hot flushes did not change over 8 weeks with low-dose oral estradiol or venlafaxine (compared with placebo), although a subtle increase in desire (estradiol) and decreases in orgasm and pain (venlafaxine) may exist.

Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01418209.

Level of evidence: I.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Cyclohexanols / pharmacology*
  • Cyclohexanols / therapeutic use
  • Double-Blind Method
  • Dyspareunia / physiopathology
  • Estradiol / pharmacology*
  • Estradiol / therapeutic use
  • Estrogens / pharmacology*
  • Estrogens / therapeutic use
  • Female
  • Hot Flashes / drug therapy*
  • Humans
  • Middle Aged
  • Orgasm / drug effects
  • Perimenopause / physiology
  • Postmenopause / physiology
  • Prospective Studies
  • Selective Serotonin Reuptake Inhibitors / pharmacology*
  • Selective Serotonin Reuptake Inhibitors / therapeutic use
  • Sexual Behavior / drug effects*
  • Sexual Behavior / physiology
  • Vagina / drug effects
  • Venlafaxine Hydrochloride

Substances

  • Cyclohexanols
  • Estrogens
  • Serotonin Uptake Inhibitors
  • Estradiol
  • Venlafaxine Hydrochloride

Associated data

  • ClinicalTrials.gov/NCT01418209