An exploratory, double blind, randomized, parallel group, placebo controlled, multicentric study to evaluate the efficacy and safety of ProvestraTM in female sexual dysfunction (FSD).
- Conditions
- Health Condition 1: null- Sexual Dysfunction
- Registration Number
- CTRI/2010/091/002919
- Lead Sponsor
- eading Edge MarketingPO Box CR-56766, Suite 1210Nassau Bahamas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
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 <3 in at least 1 domain
Willing to attempt sexual activity at least twice a week during the study period.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Female sexual Function Index (FSFI) domain scores and total scoreTimepoint: Change in FSFI scores as compared to baseline values
- Secondary Outcome Measures
Name Time Method 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 <br> poor.<br><br>?Subject opinion on willingness to continue the treatment<br><br>?Change in values of safety variables as compared to baseline values <br><br>?Tolerability to the investigational product.<br>