Sexual Dysfunctions, PsychologicalPhase 3FSIADNCT04433559

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

A Phase 3 study testing Tadalafil 1,5 mg oral tablets in people with Sexual Dysfunctions, Psychological, run by Lidia Larrañaga.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Sexual Dysfunctions, Psychological
What is being tested?: Tadalafil 1,5 mg oral tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: No sites listed yet
Study dates: Aug 2020to Aug 2021
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
contraceptive methods or partner vasectomy, and confirm who are not pregnant by pregnancy test negative in the Selection Consultation.
2. Signature of the informed consent obtained in writing,including a data protection declaration before the participation in the study.
3. Women with disorders of interest and sexual arousal diagnosed using a semi-structured questionnaire of 5 questions based on DSM-V criteria.

Who cannot join

The following groups of patients with cardiovascular risk:
Patients who had suffered myocardial infarction in the 90s previous days,
Patients with unstable angina or angina produced during sexual activity,
Patients with heart failure corresponding to class II or higher than the New York Heart Association classification (NYHA) in the previous 6 months,
Patients with uncontrolled arrhythmias,
Patients who had suffered a stroke in the previous 6 months.

Show all 27Show fewer

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.
Lactation
Hypersensitivity to tadalafil and / or drugs and products related (including excipients of the formulation).
Patients undergoing treatment with any form of organic nitrate.
Patients on treatment with potent CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole, clarithromycin, erythromycin, and saquinavir) and strong CYP3A4 inducers (carbamazepine, phenytoin, phenobarbital, St. John's wort, rifampin).
Patients who have loss of vision in one eye a consequence of anterior ischemic optic neuropathy not arteritic.
Patients with any pelvic surgery in the previous 6 months.
Known history of drug and / or alcohol abuse in the 6 months prior to the selection consultation.
Participation in another study in the 3 months prior to the consultation of selection.
Any illness that, in the investigator's judgment, can interfere with compliance with study procedures or study evaluations.
Patient with any medical or surgical condition that may interfere with absorption, distribution, metabolism or excretion of the study drug according to the criteria of the researcher.
Patients in judicial or police custody.
Patients with difficulties in understanding the language in which they gives the information to the subject.
Patients who do not agree to the transmission of their anonymous data regarding the documentation and notification functions.
Study center, sponsor or CRO staff, their own researcher or relatives of the same.

About this study

Official title: 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.

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.

Read the 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: Sexual Dysfunctions, Psychological
Being tested: Tadalafil 1,5 mg oral tablets, Placebo oral tablets
Medical subject headings: Sexual Dysfunctions, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tadalafil 1,5 mg oral tabletsDrug
Also called Tadalafil
Use of tadalafil in the treatment of FSIAD
Placebo oral tabletsDrug
Also called Placebo
Use of placebo in control group

Study groups in NCT04433559
Study group	Role	What they receive
Group Active Tadalafile	Active comparator	One oral tablet of 1.5 mg IPDE daily for 14 weeks of treatment. Receives: Drug: Tadalafil 1,5 mg oral tablets
Group Placebo	Placebo comparator	One oral tablet of placebo daily for 14 weeks of treatment. Receives: Drug: Placebo oral tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of IPDE (Tadalafile) according to FSFI (Female Sexual Function Index)
To determine the effect of IPDE at a dose of 1.5 mg versus placebo in women with disorders of interest and sexual arousal using the FSFI (Female Sexual Function Index).
FSFI contains 19 questions, with each questions with a value minimum of 0 and maximum of 6 points, beeing 0 the worst scenario y 6 the best scenario.
Measured: 14 weeks

Secondary outcomes (6)

Comparative IPDE Vs placebo according to FSFI
To compare the effect of IPDE with respect to placebo in women with disorders of interest and sexual arousal using the FSFI (Female Sexual Function Index).
FSFI contains 19 questions, with each questions with a value minimum of 0 and maximum of 6 points, beeing 0 the worst scenario y 6 the best scenario.
Measured: 14 weeks
Comparaive of IPDE Vs placebo according NSSS-Short (New Sexual Satisfaction Scale)
To compare the effect of IPDE with respect to placebo in women with disorders of interest and sexual arousal using the questionnaire "The New Sexual Satisfaction Scale" (NSSS-Short).
NSSS-Short (New Sexual Satisfaction Scale) contains 7 questions, with each questions with a value minimum of 0 and maximum of 100 points, beeing 0 the worst scenario y 100 the best scenario.
Measured: 14 weeks
Comparative IPDE Vs placebo according to the TSQM (Treatment Satisfaction questionnaire for Medication)
To compare the effect of IPDE with respect to placebo in women with disorders of interest and sexual arousal using the "Treatment Satisfaction questionnaire for Medication" (TSQM) version 1.4.
TSQM (Treatment Satisfaction questionnaire for Medication) contains 14 questions with each questions with a value minimum of 0 and maximum of 80 points, beeing 0 the worst scenario y 80 the best scenario.
Measured: 14 weeks
Comparative of IPDE Vs placebo according to number of sexual events
To compare the effect of IPDE with respect to placebo in women with sexual interest and arousal disorder by measuring the number of sexual events recorded in the weekly diary.
The diary will be fullfilled by the women according to the number of sexual events.
Measured: 14 weeks
Comparative of IPDE Vs placebo according to the sexual satisfaction
To compare the effect of IPDE with respect to placebo in women with sexual interest and arousal disorder by measuring the sexual satisfaction of sexual intercourse.
The scale will contain 3 questions, with a visual analog scale. This visual analog scale will contain a scale with different visual easy identificable progesion faces, from very sad face to very happy face, beeging the first sad face, the no satisfaction point, and the last very happy face the very satisfactory sexual event point.
Measured: 14 weeks
Comparative of IPDE Vs placebo according to ease of arousal
To compare the effect of IPDE with respect to placebo in women with disorder of interest and sexual arousal by measuring the ease of arousal during sexual intercourse determined using an analog visual scale.
The scale will contain 3 questions, with a visual analog scale. This visual analog scale will contain a scale with different visual easy identificable progesion faces, from very sad face to very happy face, beeging the first sad face, the no satisfaction point, and the last very happy face the very satisfactory sexual event point.
Measured: 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2020Aug 2021

First posted16 Jun 2020
Study startAug 2020 (estimated)
Primary completionAug 2021 (estimated)
Study completionAug 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sexual Dysfunctions, PsychologicalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04433559
Sponsor's protocol ID: LITA-004
Acronym: FSIAD
Status last verified: Jun 2020
First submitted: 6 May 2020
Last updated: 16 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT04433559
Acronym / sponsor ID: FSIAD / LITA-004
Conditions: Sexual Dysfunctions, Psychological
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Lidia LarrañagaIndustry (pharma, biotech, devices)
Study start: Aug 2020 (estimated)
Primary completion: Aug 2021 (estimated)
Study completion: Aug 2021 (estimated)
First posted: 16 Jun 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group Active Tadalafile	Active comparator	Drug: Tadalafil 1,5 mg oral tabletsOne oral tablet of 1.5 mg IPDE daily for 14 weeks of treatment.
Group Placebo	Placebo comparator	Drug: Placebo oral tabletsOne oral tablet of placebo daily for 14 weeks of treatment.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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:
2. Signature of the informed consent obtained in writing,including a data protection declaration before the participation in the study.
3. Women with disorders of interest and sexual arousal diagnosed using a semi-structured questionnaire of 5 questions based on DSM-V criteria.

Key exclusion criteria (27 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tadalafil 1,5 mg oral tabletsAlso: TadalafilUse of tadalafil in the treatment of FSIAD	Drug	Group Active Tadalafile
Placebo oral tabletsAlso: PlaceboUse of placebo in control group	Drug	Group Placebo

Primary outcome

Effect of IPDE (Tadalafile) according to FSFI (Female Sexual Function Index)
Time frame: 14 weeks
To determine the effect of IPDE at a dose of 1.5 mg versus placebo in women with disorders of interest and sexual arousal using the FSFI (Female Sexual Function Index). FSFI contains 19 questions, with each questions with a value minimum of 0 and maximum of 6 points, beeing 0 the worst scenario y 6 the best scenario.

6 secondary outcomes

Comparative IPDE Vs placebo according to FSFI
Time frame: 14 weeks
Comparaive of IPDE Vs placebo according NSSS-Short (New Sexual Satisfaction Scale)
Time frame: 14 weeks
Comparative IPDE Vs placebo according to the TSQM (Treatment Satisfaction questionnaire for Medication)
Time frame: 14 weeks
Comparative of IPDE Vs placebo according to number of sexual events
Time frame: 14 weeks
Comparative of IPDE Vs placebo according to the sexual satisfaction
Time frame: 14 weeks
Comparative of IPDE Vs placebo according to ease of arousal
Time frame: 14 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tadalafil 1,5 mg oral tablets in people with Sexual Dysfunctions, Psychological, run by Lidia Larrañaga.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of IPDE (Tadalafile) according to FSFI (Female Sexual Function Index) (time frame: 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04433559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.