article · Menopause The Journal of The North American Menopause Society
A pooled analysis of two phase 3 randomised placebo-controlled trials examined the effects of low-dose paroxetine on body weight and sexual function in postmenopausal women. The trials evaluated women aged 40 years and older experiencing moderate to severe vasomotor symptoms who took either 7.5 mg of paroxetine or a placebo once daily for 12 or 24 weeks. Across more than 1,170 participants, baseline weight, body mass index, and rates of sexual dysfunction were comparable between groups. Treatment with low-dose paroxetine resulted in no statistically significant or clinically meaningful alterations in body weight, body mass index, or sexual function measures. Furthermore, rates of adverse events related to sexual dysfunction were low and matched those seen with placebo. Overall, the findings confirm that paroxetine 7.5 mg manages vasomotor symptoms without inducing weight gain or adverse changes in libido.
Many women experiencing menopausal vasomotor symptoms seek non-hormonal treatment alternatives but worry about common medication side effects such as weight gain and reduced libido. By demonstrating that a low 7.5 mg dose of paroxetine avoids these adverse effects, this evidence provides reassurance to patients and healthcare professionals considering this therapy for managing hot flushes and night sweats.
Derived from completed phase 3 clinical trials, these findings provide late-stage clinical evidence supporting the use of 7.5 mg paroxetine as an applied, near-market treatment. The primary users are healthcare providers and postmenopausal women seeking relief from moderate to severe vasomotor symptoms. Because weight gain and sexual side effects frequently hinder drug compliance, establishing this neutral tolerability profile supports clinical adoption and commercial positioning of low-dose formulations.
AI-generated from the published abstract. Always read the original work before citing.
OBJECTIVE: Two phase 3, randomized, placebo-controlled trials demonstrated that low-dose paroxetine 7.5 mg reduced the frequency and severity of vasomotor symptoms (VMS) associated with menopause and had a favorable tolerability profile. The impact of paroxetine 7.5 mg on body weight and sexual function was evaluated in a pooled analysis. METHODS: Postmenopausal women aged 40 years or older who had moderate to severe VMS were randomly assigned to receive paroxetine 7.5 mg or placebo once daily for 12 or 24 weeks. Assessments included changes in body mass index (BMI) and weight, Arizona Sexual Experiences Scale score, Hot Flash-Related Daily Interference Scale sexuality subscore, and adverse events related to weight or sexual dysfunction. RESULTS: Pooled efficacy and safety populations comprised 1,174 and 1,175 participants, respectively. Baseline values were similar for median weight (∼75 kg), median BMI (∼28 kg/m), and the proportion of women with sexual dysfunction (∼58%). No clinically meaningful or statistically significant changes from baseline in weight or sexual function assessments occurred in the paroxetine 7.5 mg group. Small but statistically significant increases in weight and BMI were observed in the placebo group only on week 4. No significant difference between treatment groups was observed in the proportion of participants who had 7% or higher gain in body weight on week 4, 12, or 24. Rates of adverse events suggestive of sexual dysfunction were low and similar in both treatment groups. CONCLUSIONS: Paroxetine 7.5 mg does not cause weight gain or negative changes in libido when used to treat menopause-associated VMS in postmenopausal women.
This page summarises published work. The authoritative version sits with the publisher.
DOI: 10.1097/gme.0000000000000210
Is something wrong with this record? Report it or request removal.
Discussion
Have you built on this work, tried to replicate it, or seen it applied in practice? Share what you know. Verified researchers and MARATTO™ domain experts can open a discussion, and any member can reply. Contributions are reviewed before they appear.
No discussion yet. Open the first thread.
New to MARATTO™? Create a free account.
