Evaluation of the Sexual Function and Vaginal environment of menopausal women before and after treatment.
Not Applicable
Recruiting
- Conditions
- Female urogenital diseases and pregnancy complications, postmenopause, atrophy, sexual dysfunction physiological, urinary incontinence, vulvovaginitis.
- Registration Number
- RBR-94dx93
- Lead Sponsor
- niversidade Federal do Rio Grande do Norte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
The study will include healthy postmenopausal women (55 to 65 years old, with whom at least 12 months have passed since last menstrual period or bilateral oophorectomy), who are still sexually active, with GSM, plasma gonadotropin and presenting serum estradiol levels in the postmenopausal range (FSH >40 U/L; estradiol <25 pg/ml) as well as negative Papanicolaou (Pap) smear for cervical cancer precursor cells.
Exclusion Criteria
Women who have used any form of hormonal (systemic or local) therapy in the last six months, lubricants or vaginal moisturizers in the past month, suffering from active genital infections (diagnosis by GRAM stain and Multiplex-PCR), and any disease that would interfere following the protocol.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome includes vulvovaginal atrophy (vaginal pain, burning, itching, dryness, dyspareunia, and dysuria), using the 11-point Visual Analog Scale (VAS).
- Secondary Outcome Measures
Name Time Method The Secondary outcome includes the sexual function, using the Female Sexual Index (FSFI), vaginal health (epithelial integrity, vaginal elasticity, moisture, fluid volume, and pH vaginal), using the Vaginal Health Index (VHI), the quality of life using the Short Form 12 (SF-12) to assess physical (PCS12) and mental (MCS12) component, beyond the vaginal microbiota, and cell maturation.