Female Sexual Interest/Arousal Disorder Clinical Trial
— VITALOfficial title:
National, Multicentric, Randomized, Single-blind, Active-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Libicare® in Women With Low Arousal and Sexual Desire Levels
| Verified date | April 2024 |
| Source | Procare Health Iberia S.L. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the effectiveness of Libicare® in the sexual desire and arousal at 12 weeks in peri or postmenopausal women aged between 40 and 60 years old with low sexual desire and arousal compared with active control.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 30, 2023 |
| Est. primary completion date | November 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 45 Years and older |
| Eligibility | Inclusion Criteria: 1. Female aged between 40 and 60 years old. 2. Healthy peri or postmenopausal women. 3. Body Mass Index (BMI) between 18,5-29,9. 4. Female with low sexual desire and low arousal with a score =26.55 on the questionnaire Female Sexual Function Index (FSFI) . 5. Patients who signed the Informed Consent Form. Exclusion Criteria: 1. Female with uncontrolled thyroid function. 2. Female with severe genital pain (vaginism, stopping intercourse because of severe pain). 3. Female diagnosed with primary female orgasmic disorder. 4. No coital intercourse a month. 5. Lack of steady sexual partner. 6. Suffering from any serious medical condition (any disease which may force the participant to use drug during the study). 7. Suffering from major depression disorder or other psychiatric disorders. 8. Women on anticoagulant treatment. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Procare Health Iberia | Castelldefels | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Procare Health Iberia S.L. |
Spain,
Akhtari E, Raisi F, Keshavarz M, Hosseini H, Sohrabvand F, Bioos S, Kamalinejad M, Ghobadi A. Tribulus terrestris for treatment of sexual dysfunction in women: randomized double-blind placebo - controlled study. Daru. 2014 Apr 28;22(1):40. doi: 10.1186/20 — View Citation
Rao A, Steels E, Beccaria G, Inder WJ, Vitetta L. Influence of a Specialized Trigonella foenum-graecum Seed Extract (Libifem), on Testosterone, Estradiol and Sexual Function in Healthy Menstruating Women, a Randomised Placebo Controlled Study. Phytother R — View Citation
Zhao J, Dasmahapatra AK, Khan SI, Khan IA. Anti-aromatase activity of the constituents from damiana (Turnera diffusa). J Ethnopharmacol. 2008 Dec 8;120(3):387-93. doi: 10.1016/j.jep.2008.09.016. Epub 2008 Sep 26. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evolution of sexual desire and arousal | The evolution of the composite score from sexual desire and arousal obtained using FSFI (Female Sexual Function Index) questionnaire. It has 19 questions with six domains included desire, arousal, lubrication, orgasm, satisfaction and pain, and a general score in which higher scores reflected better sexual activity. | 12 weeks | |
| Secondary | The evolution of the composite score from sexual desire and arousal | The evolution of the composite score from sexual desire and arousal obtained using FSFI (Female Sexual Function Index) questionnaire. It has 19 questions with six domains included desire, arousal, lubrication, orgasm, satisfaction and pain, and a general score in which higher scores reflected better sexual activity. | at 6 and 24 weeks | |
| Secondary | The evolution of the FSFI questionnaire total score | The evolution of the FSFI (Female Sexual Function Index) questionnaire total score. Composite score from sexual desire and arousal domains will be calculed as the sum of desire items (2 questions) and arousal items (4 questions). Higher scores reflected better sexual activity. | at 6, 12 and 24 weeks | |
| Secondary | The evolution of other each sexual FSFI domain score | The evolution of other each sexual FSFI domain score (Female Sexual Function Index) It contains 2 questions of desire domain and 4 questions of arousal domain. Higher scores reflected better sexual activity. | at 6, 12 and 24 weeks | |
| Secondary | To evaluate the hormonal levels (free testosterone and SHBG) | changes in hormonals levels | at 6, 12 and 24 weeks | |
| Secondary | The evolution of the vitality status obtained using the Subjective Vitality Scale questionnaire | The evolution of the vitality scale (an 7-point Likert Scale) contains 7 items. Higher scores reflected better vitality status. | at 12 and 24 weeks | |
| Secondary | The improvement in the Quality of life of women by EQ-5D-5L questionnaire | The improvement in the Quality of life of women by EQ-5D-5L (European Quality of Life-5 Dimensions) questionnaire. It comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The result is in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | at 12 and 24 weeks | |
| Secondary | Clinical satisfaction of the women with the treatment, using a Likert-type scale | Clinical satisfaction of the women with the treatment, using a Likert-type scale of 7 points (from 1 = Very satisfied to 7 = Very dissatisfied) | at 6, 12 and 24 weeks | |
| Secondary | The improvement of is frequency of intercourse and non-intercourse activity (total and satisfying events), number of orgasms using the SAL© | The improvement of is frequency of intercourse and non-intercourse activity (total and satisfying events), number of orgasms using the SAL© ((Sexual Activity Log©). It is a weekly diary that it measures frequency of intercourse and non-intercourse activity (total and satisfying events), number of orgasms. | at 6, 12 and 24 weeks | |
| Secondary | The evaluation of the degree of therapeutic compliance | The evaluation of the degree of therapeutic compliance throught Likert Scale of 5 points (from 1 = Very satisfied to 5 = Very dissatisfied) will be analysed by means of percentage. | at 6, 12 and 24 weeks | |
| Secondary | Adverse events and adverse drug reactions | To evaluate the safety of libicare measuring the incidence and duration of adverse events and adverse drug reactions. | at 6, 12 and 24 weeks. | |
| Secondary | Weight, height and BMI | Safety endpoint for evaluating weigh and BMI (body mass index) changes. | at baseline, 6, 12 and 24 weeks |