Drugs in early clinical development for the treatment of female sexual dysfunction.
Belkin. Zoe R ZR; Krapf. Jill M JM; Goldstein. Andrew T AT
Key Findings
- There are no FDA‑approved drugs for the most common female sexual complaint—decreased desire.
- Bremelanotide (pt‑141) is in early clinical trials and has shown some promise in improving sexual interest/arousal.
- Other agents being explored include topical alprostadil, intranasal testosterone, intravaginal DHEA, and combinations like sublingual testosterone with sildenafil.
- Most studies still use older DSM‑IV‑R definitions rather than the newer DSM‑5 classification.
Practical Outcomes
- For biohackers, pt‑141 is not yet a legally available or proven option, so it can't be added to a self‑experiment protocol today. Keep an eye on emerging Phase II data for dosing and safety signals, and consider discussing off‑label use only with a qualified clinician if you decide to explore it in the future.
Summary
This review looks at drugs that are still in early testing for women who have low sexual desire, a condition that currently has no approved medication. One of the candidates is pt‑141 (bremelanotide), a peptide that may boost desire when given as a nasal spray or injection. The paper lists several other compounds in Phase I‑II trials, but all are experimental and not yet on the market.
Abstract
There is growing recognition of female sexual dysfunction (FSD) as an important women's health concern. Despite an increased awareness of the pathophysiologic components to FSD, currently, there are no drugs approved for the most common sexual complaint in women-decreased sexual desire. In response to an overwhelming demand for therapy for FSD, several drugs are undergoing development and testing. The aim of this paper is to provide the latest data on pharmacological treatments for FSD currently in Phase I and II clinical trials. These include topical alprostadil, bremelanotide (BMT), intranasal testosterone (TBS-2), intravaginal dehydroepiandrosterone (DHEA), sublingual testosterone with sildenafil, apomorphine (APO), bupropprion and trazodone. It should be noted that the definitions of FSD have recently been revised in the diagnostic and statistical manual for mental disorders (DSM) 5, with merging of hypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD) into female sexual interest/arousal disorder (FSIAD). However, it is noted that the majority of clinical trials discussed in this paper use the DSM IV-R diagnoses of HSDD and FSAD. Medications in early phase trials show promise for the treatment of FSD. These therapies focus on treating many possible causes of FSD. Concerns over gender bias within the FDA need to be resolved given the need for new treatment options for FSD.
Study Information
pubmed
2014
2014-11-06T00:00:00.000Z
10.1517/13543784.2015.978283
33
46