UnknownPhase 3

Study of Pharmacological Treatment in Women With Female Sexual Interest/Arousal Disorder (FSIAD).

80 participantsStarted 2020-08

Plain-language summary

This clinical trial is a prospective, randomized, double-blind Phase III study with two arms to determine the efficacy and safety of the use of an IPDE in women with FSIAD. Patients who meet all inclusion criteria and do not meet any of the exclusion criteria will enter the study and receive active product or placebo for 14 weeks. Patients will be assigned to each treatment group in a randomized and parallel manner. In addition, all volunteers participating in the study will receive medical advice during the study. The study will have a duration of minimum of 18 weeks and will consist of 3 periods.

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. Women between 18 and 65 years old. Women of childbearing age (premenopausal, not surgically sterilized at least 3 months before the Selection Visit) must be used during the study a highly effective contraceptive method such as:

Exclusion criteria

✕. The following groups of patients with cardiovascular risk:
✕. Patients with disorders of female sexual arousal of origin neurogenic.
✕. Patients with female sexual dysfunction associated with disorders psychiatric.
✕. Patients with a partner who suffers from sexual dysfunction.
✕. Patients with dysphoric excitation disorder and / or with sensation unpleasant genital thickening.
✕. Patients with a history of severe thromboembolic disease, hepatic, renal, or neoplastic.
✕. Uncontrolled diabetic patients (HbA1c\> 8% in the last control).
✕. Patients with depression and / or taking antidepressants.

What they're measuring

Effect of IPDE (Tadalafile) according to FSFI (Female Sexual Function Index)

Timeframe: 14 weeks

Trial details

NCT IDNCT04433559

SponsorLidia Larrañaga

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08

View on ClinicalTrials.gov More Sexual Dysfunctions, Psychological trials