Sexual interest and arousal disorder in menopausal and hierpertensive women
Conditions
Interventions
Trade Name: Cialis 5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: TADALAFIL
CAS Number: 171596-29-5
Concentration unit: mg millig
Sponsors
Litaphar S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Menopausal women until the age of 65 year with date of last menstruation >1 year. 2. Signed informed consent including data protection declaration prior to study participation. 3. Women with sexual interest and arousal disorder diagnosed through an semi-strucuted questionnarie of 5 questions based on the criteria of the DSM-V. 4. Patients with history of well controlled essential arterial hypertension for >1 year (with the last control at most within the last 6 months prior to Screening Visit, that have not suffered changes in her antihypertensive medication within the last 6 months and with diastolic and systolic pressure at Screening Visit =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. The following patients groups: ? Patients who have suffered heart attack in the past 90 days, ? Patients with unstable angina or angina caused during sexual activity ? Patients with cardiac insufficiency correponding to class II or higher of the New York Heart Association (NYHA) classification in the previous 6 months, ? Patients with uncontrolled arrythmia, ? Patients who have suffered cerebrovascular accident within the previous 6 months, 2. Patients with neurogenic origin female sexual arousal disorder. 3. Patients with female sexual dysfuntion associated with psychiatric disorders. 4. Patients with sustitutive hormone treatment. 5. Patients without sexual partner, or affected by her partner?s situational sexual dysfunction, or with partner that suffers sexual dysfunction. 6. Patients with dysphoric arousal disorder and/or with unpleasant sensation of genital thickening. 7. Patients with history of serious thromboembolic disease, hepatic, renal, or neoplastic. 8. Non-controlled diabetic patients (HbA1c>8% in the last control). 9. Patients with depression and/or taking antidepressant drugs and/or under psychotherapy. 10. Hypersensitivity to tadalafil or related drugs and products (including excipients of the formulation). 11. Patients on treatment with any form of organic nitrate. 12. Patients on treatment with potent inhibitors of CYP3A (ritonavir, ketoconazole, itraconazole, clarothromycin, erythromycin and saquinavir) and potent inductors of CYP3A4 (carbamazepine, phenytoin, phenobarbital, St. John?s wort and rifampicin). 13. Patients on treatment with drugs that may cause sexual dysfunction as beta-blockers and thiazides. 14. Patients with vision loss in one eye as a result of nonarteritic anterior ischemic optic neuropathy 15. Patients with hysterectomy with bilateral oophorectomy <1 año ago. 16. Known history of drug and/or alcohol abuse within 6 months prior to the Screening Visit. 17. Withdrawal of infomed consent (patients that do not wish to continue in the study or not return to the consultation). 18. participation in an other investigational study within 3 months prior to Screeining Visit. 19. Any disease that, as judged by the Principal Investigator, may interfere with the compliance of study procedures or study assesments. 20. Patients with any medical or surgical condition that may interfere with the absorption, distribution, metabolism or excretion of the investigational medicinal product according to the investigator. 21. Patients in custody by juridical or official order. 22. Patients who have difficulties in understanding the language in which the volunteer information is given. 23. Patients who do not agree to the transmission of their anonymous data within the liability of documentation and notification 24. Staff of the study centre, staff of the sponsor or CRO, the investigator herself or close relatives of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The effect of tadalafil on clitoral blood flow in menopausal and hypertensive women with sexual interest and arousal disorder, will be determined using the average change between value at baseline and at the end of treatment of the peak systolic velocity measured by Eco-Doppler.;Timepoint(s) of evaluation of this end point: Reference Visit (C1, Week 0), Visit 2 (C2, Week 6) ,End of treatment Visit (CFT, Week 12);Main Objective: To determine the effect of tadalafil on clitoral blood flow in menopausal and hipertensive women with sexual interest and arousal disorder through Eco-Doppler; Secondary Objective: -To evaluate the efficacy of tadalafil in treatment of sexual interest and arousal disorder in menopausal women with hypertension through FSFI index (Female Sexual Function Index) -To evaluate the efficacy of tadalafil in menopausal women with hypertension diagnosed of sexual interest and arousal disorder through Scale of Evaluation of Sexual Activity in Women (EVAS-M) -To determine the effect of tadalafil in quality of life after 12 weeks of treatment according to SF-36 score -To evaluate the safety of tadalafil | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Efficacy: ? Average change in the irrigation of clitoris between the value at baseline and at the end of treatment of the following variables mesured with Eco-doppler: o Resistance Index (RI) o End-diastolic velocity (EDV) o Pulse Index (PI) ? Average change between value at baseline and at the end of treatment of total score of FSFI index. ? Average change between value at baseline and at the end of treatment in the arousal section of FSFI index. ? Average change between value at baseline and at the end of treatment in the desire section of FSFI index. ? Average change between value at baseline and at the end of treatment in the lubrication section of FSFI index. ? Average change between value at baseline and at the end of treatment in the orgasm section of FSFI index. ? Average change between value at baseline and at the end of treatment in the pleasure section of FSFI. ? Average change between value at baseline and at the end of treatment in the pain section of FSFI. ? Determination of sexual pleasure, arousal, lubrication, orgasm and pain according to the values obtained through EVAS-M scale considering the baseline values. ? Average change between value at baseline and at the end of treatment in the SF-36 questionnaire of quality of life ? Safety: Only treatment-emergent AEs will be considered in order to assess the safety and tolerability of the IMP. Observed abnormalities with respect to vital signs (systolic/diastolic blood pressure, heart rate and body temperature), 12-lead ECG, physical examination and safety laboratory tests will be documented on the CRF. Patients will register in the « patient?s diary »any adverse event that they suffer during the study. ; Timepoin | — |
Countries
Spain
Contacts
Public ContactClinical Trial Department
Dynakin S.L.
Outcome results
None listed