Sildenafil treatment of women with antidepressant-associated sexual dysfunction: a randomized controlled trial.
Given that the evidence for sildenafil in women on antidepressants comes down to one industry-funded trial, is it worth a trial run for me, or should we change something else first?
Reasonable evidence with real limitations. how we score evidence
Caveat on this rating: The funding statement reads: "This study was supported by an independent investigator-initiated grant from Pfizer Inc, New York, New York. Pfizer Inc provided sildenafil and matching placebo," with the role-of-sponsor statement adding that "Pfizer had no other role in the design and conduct of the study." Pfizer makes sildenafil, and several authors disclose financial relationships with it. The Cochrane review of this literature concluded that for women it remains uncertain whether sildenafil is more effective than placebo, and flagged that unpublished data could change the picture — a direct disagreement a reader should know about.
In 98 premenopausal women whose depression was remitted on a serotonin reuptake inhibitor but who had drug-associated sexual dysfunction, 8 weeks of sildenafil beat placebo on the clinician-rated sexual function scale by 0.8 points (95% CI 0.6 to 1.0, P = .001), shrinking to 0.6 points (95% CI 0.3 to 0.8, P = .03) once the 22% who dropped out early were counted as unchanged. Headache, flushing, and dyspepsia were frequent. This is the only positive trial of its kind in women, and the 2013 Cochrane review still calls the question unsettled.
Worth asking
Given that the evidence for sildenafil in women on antidepressants comes down to one industry-funded trial, is it worth a trial run for me, or should we change something else first?
What to watch for
Evidence quality tells you whether to trust the finding — not whether the treatment is safe. These are the risks this research reports.
- Persistent sexual dysfunction (PSSD)
- Sexual side effects
Source
Sildenafil treatment of women with antidepressant-associated sexual dysfunction: a randomized controlled trial. — Nurnberg HG, Hensley PL, Heiman JR, Croft HA, Debattista C, Paine S. (2008)
Top-tier peer-reviewed journal
Read the source: https://doi.org/10.1001/jama.300.4.395
DOI: 10.1001/jama.300.4.395
How this was scored
- Study design
- Randomised controlled trial
- Funding
- Industry funded
- Published in
- Top-tier peer-reviewed journal
- Sample size
- 98
- Preregistered
- Yes
- Conflicts disclosed
- Yes
- Independent of proponent
- No
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published August 19, 2026.
Where we put this study in context
Questions
How strong is the evidence behind this?
Resolv rates this source "moderate evidence". Reasonable evidence with real limitations. It scores 57 out of 100 on our published rubric. One caveat travels with that badge: The funding statement reads: "This study was supported by an independent investigator-initiated grant from Pfizer Inc, New York, New York. Pfizer Inc provided sildenafil and matching placebo," with the role-of-sponsor statement adding that "Pfizer had no other role in the design and conduct of the study." Pfizer makes sildenafil, and several authors disclose financial relationships with it. The Cochrane review of this literature concluded that for women it remains uncertain whether sildenafil is more effective than placebo, and flagged that unpublished data could change the picture — a direct disagreement a reader should know about. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
Sildenafil treatment of women with antidepressant-associated sexual dysfunction: a randomized controlled trial. — Nurnberg HG, Hensley PL, Heiman JR, Croft HA, Debattista C, Paine S. (2008). Published in: Top-tier peer-reviewed journal. DOI: 10.1001/jama.300.4.395. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Randomised controlled trial. Funding: Industry funded. The researchers were not independent of whoever benefits from the result. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.