Trials / Unknown
UnknownNCT04433559
Study of Pharmacological Treatment in Women With Female Sexual Interest/Arousal Disorder (FSIAD).
Randomized, Double-blind, Two-arms Study With Parallel Groups to Determine the Effect of a Phosphodiesterase Inhibitor for 14 Weeks of Treatment Versus Placebo in Women With FSIAD.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Lidia Larrañaga · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tadalafil 1,5 mg oral tablets | Use of tadalafil in the treatment of FSIAD |
| DRUG | Placebo oral tablets | Use of placebo in control group |
Timeline
- Start date
- 2020-08-01
- Primary completion
- 2021-08-01
- Completion
- 2021-08-01
- First posted
- 2020-06-16
- Last updated
- 2020-06-16
Source: ClinicalTrials.gov record NCT04433559. Inclusion in this directory is not an endorsement.