Female Sexual Arousal Disorder (FSAD), a subtype of female sexual dysfunction, is an inability to attain, or to maintain an adequate lubrication-swelling response of sexual excitement. There is no currently approved treatment for FSAD. The goal of this clinical trial is to assess the efficacy and safety of the study drug, Estetrol, for the treatment of Female Sexual Arousal Disorder associated with menopause in hysterectomized postmenopausal women. Estretrol is a natural estrogenic steroid that is normally produced by the human fetal liver.

The potential benefits to participants would be study-related medical care at no-cost and knowledge gained about their condition. On a wider scale, there may be general benefits to society because the investigational treatment may become a future treatment option.

To qualify for the study, you must be:

  • Postmenopausal Female between 40 to 65 years of age at Visit 1 (Randomization).
  • Diagnosed with Female Sexual Arousal Disorder. Symptoms of FSAD should not be caused by:
    ‒ A coexisting medical or psychiatric condition.
    ‒ Problems within the relationship.
    ‒ The effects of a medication or other drug substance.
  • Documented hysterectomy (with or without oophorectomy) must have occurred at
    least 6 months prior to the start of screening. Hysterectomy can be total or subtotal
    (i.e., cervix was not removed).
  • Body mass index (BMI) ≥18.0 kg/m² up to ≤38.0 kg/m².
  • Other criteria may apply*

*There are multiple studies available to participate in and each may require different criteria to be approved as a participant.

To learn more about this trial and to find out if you qualify, please call 402.934.0044 or complete the form on our Contact page.