Health Condition 1: null- Sexual Dysfunction
Conditions
Interventions
Intervention1: Provestra TM: One Tablet Once in a day preferably with meals for 84 Days
Control Intervention1: Placebo: One Tablet once in a day for 60 days
Sponsors
Leading Edge Marketing
PO Box CR-56766, Suite 1210
Nassau Bahamas
Eligibility
Inclusion criteria
Inclusion criteria: Sexually active female aged between 21-55 yrs, in a stable monogamous relationship with a male partner for at least 6 months and who has been involved in sexual intercourse over the last four weeks Females who have mixed desire / arousal /orgasm disorder and are distressed due to it since at least 3 months Females with a baseline FSFI score of ≤ 20 and/or a domain score of Willing to attempt sexual activity at least twice a week during the study period.
Exclusion criteria
Exclusion criteria: Women whose sexual dysfunction is limited to certain types of stimulation, situation or specific partners. BMI > 40 kg/m2 Evidence of unresolved sexual trauma or abuse. Primary anorgasmia, vaginismus, sexual pain disorder, sexual aversion disorder, or persistent sexual arousal disorder. ? Female sexual dysfunction caused by untreated endocrine disease, e.g., hypopituitarism, hypothyroidism, diabetes mellitus; Hyperprolactinemia Chronic or complicated urinary tract or vaginal infections within previous 12 months (as determined by history). Pelvic inflammatory disease within previous 12 months. Currently active sexually transmitted disease. Chronic dyspareunia not attributable to vaginal dryness within previous 12 months. Currently active moderate to severe vaginitis. Cervical dysplasia within previous 12 months. Significant cervicitis as manifested by mucopurulent discharge from the cervix. Significant gynecologic conditions such as uterine fibroids, vulvar vestibulitis, or vaginismus that may (in the investigator?s opinion) interfere with the subject?s ability to comply with study procedures. Psychoses, bipolar and anxiety disorders. History or evidence of significant cardiac, renal or hepatic disease within previous 6 months. Significant central nervous system diseases within the last 6 months, i.e., stroke, spinal cord injury, multiple sclerosis, etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Female sexual Function Index (FSFI) domain scores and total scoreTimepoint: Change in FSFI scores as compared to baseline values | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of ProvestraTM in females suffering with FSD.Timepoint: ? Grade assigned by investigator to the investigational product as good, fair or poor. ? Subject opinion on willingness to continue the treatment ? Change in values of safety variables as compared to baseline values ? Tolerability to the investigational product. | — |
Countries
India
Contacts
Public ContactMs. Sakshi Pawar
Outcome results
None listed