Dyspareunia
Conditions
Keywords
vulvovaginal atrophy, dyspareunia, prasterone, vulvoscopy
Brief summary
Open label study at a single research center. Subjects meeting inclusion and exclusion criteria will receive 6.5 mg prasterone vaginal inserts daily for twenty weeks. A physical examination and vulvoscopy with photography of the vulva, vestibule, urethral meatus and vagina will be performed at baseline and every 4 weeks for 20 weeks. Pain diaries will be completed between visits.
Detailed description
This is an open label study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive 6.5 mg prasterone vaginal inserts daily for twenty weeks. After the informed consent is signed, a baseline physical examination and vulvoscopy with detailed photography of the vulva, vestibule, urethral meatus and vagina will be performed. Physical examination and vulvoscopy with detailed photography of the vulva, vestibule, urethral meatus and vagina will be repeated prospectively every 4 weeks for a total of 20 weeks. Therefore, physical examination and vulvoscopy with detailed photography of the vulva, vestibule, urethral meatus and vagina will be performed prospectively at baseline (vulvoscopy session 1), 4 weeks (vulvoscopy session 2), 8 weeks (vulvoscopy session 3), 12 weeks (vulvoscopy session 4), 16 weeks (vulvoscopy session 5) and 20 weeks (vulvoscopy session 6) following daily administration of 6.5 mg prasterone. In addition, pain diaries will be dispensed at each visit and collected at the following visit, with questions regarding pain during sexual activity.
Interventions
DRUGPrasterone
6.5 vaginal insert prasterone (dehydroepiandrosterone)
Sponsors
San Diego Sexual Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label study of daily administration of 6.5 mg prasterone, approved for moderate to severe dyspareunia for vaginal atrophy in menopausal women, to see if there are changes to the vulva, vestibule, urethral meatus and vagina on vulvoscopy after 20 weeks
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* provides written informed consent and HIPAA authorization before any study procedures are conducted; * has a body mass index (BMI) \< 37 kg/m2 * is menopausal either naturally (at least 12 months amenorrheic) or 6 weeks after a bilateral salpingo-oophorectomy prior to natural menopause; subjects with hysterectomy only must have a serum FSH \> 40 mIU/mL; * has vulvovaginal atrophy with moderate to severe dyspareunia; * has at least one score ≥ 2 on cotton-tipped swab test * agrees to comply with the study procedures and visits.
Exclusion criteria
* has a hypersensitivity to DHEA; * has used prasterone in the past 6 months; * has documented or suspected breast cancer; * has undiagnosed genital bleeding: * has clinically significant findings on physical examination; * has uncontrolled hypertension; * has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study; * is currently on local or systemic androgen therapy including local or systemic testosterone (washout 14 days for local or topical androgen or non-depot injection, 1 month for depot, 6 months for pellet; * is currently on local or systemic estrogen therapy or androgen therapy (washout 14 days for vaginal estrogen, 60 days for oral/transdermal therapy); * is currently using a selective estrogen receptor modulator (SERM) or products that have estrogenic or anti-estrogenic effects within last month; * has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week; * has received an investigational drug within 30 days prior to signing consent; * has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vulvoscopic changes to the vulva, vestibule, urethral meatus and vaginal region on VGTA scale | Twenty weeks | The primary objective of this study is to prospectively document, using vulvoscopy with detailed photography, the visible changes to the vulva, vestibule, urethral meatus and vaginal region in menopausal women with moderate to severe dyspareunia using 6.5 mg daily prasterone for twenty weeks, comparing baseline to 20 weeks. Photographs will be assessed by an independent reviewer using a ten-parameter Likert rating scale, the Vulvoscopic Genitourinary Tissue Appearance (VGTA) scale. This scale assesses for labia majora resorption, labia minora resorption, clitoral atrophy, urethral meatal prolapse, introital stenosis, pallor, erythema, mucosa inflammation, loss of vaginal ruggation, and anterior vaginal wall atrophy. VGTA values for each parameter are 0 (normal), 1(mild), 2 (moderate) or 3 (severe). Each parameter will be calculated separately as well as the total score as primary outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pain as noted on cotton-tipped swab (Q-tips®) test. | Twenty weeks | Secondary objectives include changes in pain as noted on the Pain Scale during the cotton-tipped swab (Q-tips®) test. Pain is assessed by applying pressure with the cotton-tipped swab in 7 specific locations around the vestibule (1:00, 3:00, 5:00, 6:00, 7:00, 9:00 and 11:00) and the patient is asked to assess her pain at each location on a scale of 0-3 with 0 being no pain and 3 being the most severe. The total score is then used to determine outcome. |
| Subject diary | Twenty weeks | Changes in responses to questions on subject diary from first 4 week period prior to start of medication, to last 4 week period ending at twenty weeks. |
Countries
United States
Outcome results
None listed