Clinical trial NCT02784613: Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA
Official title: Open-Label Pilot Prospective Vulvoscopy Photography Study of Visible Changes in the Vulva, Vestibule, Vagina Pre/Post 20 Weeks of Daily Administration 60 Mg Ospemifene in Post-Menopausal Women With Dyspareunia From Vulvar Vaginal Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vulvovaginal Atrophy
Dyspareunia
Lead sponsor: San Diego Sexual Medicine
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 10
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive 60 mg ospemifene daily for twenty weeks. After the informed consent is signed, a baseline physical examination, and vulvoscopy with detailed photography of the vulva, vestibule and vagina, will be performed. Physical examination and vulvoscopy with detailed photography of the vulva, vestibule 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 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 60 mg ospemifene.

Detailed description: Ospemifene is indicated for post-menopausal women diagnosed with vulvar vaginal atrophy (VVA) and dyspareunia. While ospemifene clinically significantly reduces pain associated with dyspareunia, there has been little prospective documentation using vulvoscopy with detailed photography of the visible changes to the vulva, vestibule and vaginal region with daily administration of 60 mg ospemifene in post-menopausal women with VVA and dyspareunia. This study will include a total of 6 prospective photographic sessions of the vulva, vestibule and vagina over the 20 weeks administration of 60 mg ospemifene in the study. Comparisons will be made of baseline photography (vulvoscopy session 0) with photography at 4 weeks (vulvoscopy session 1), 8 weeks (vulvoscopy session 2), 12 weeks (vulvoscopy session 3), 16 weeks (vulvoscopy session 4) and 20 weeks (vulvoscopy session 5).

Currently there have been limited prospective studies using vulvoscopy with detailed photography demonstrating visible changes to the vulva, vestibule and vagina following oral administration of 60 mg ospemifene in post-menopausal women with VVA and dyspareunia. Information regarding visible changes to the vulva, vestibule and vagina may be very important to the patient and to the health care provider to best understand the beneficial effects of ospemifene and to ensure patient compliance with treatment.

Eligibility criteria: Inclusion Criteria:

1. Subject provides written informed consent and HIPAA authorization before any study procedures are conducted
2. Subject is female
3. Subject is aged 21-80 years
4. Subject has a body mass index (BMI) \< 37 kg/m2
5. Subject 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 Follicle Stimulating Hormone \> 40 milli-International unit /mL
6. Subject has vulvovaginal atrophy with dyspareunia
7. Subject has had a normal mammogram within the last 6 months
8. Subject has normal pap smear within last 6 months
9. Subject has an endometrial stripe ≤ 4 mm within the last 6 months if she has a uterus
10. Subject agrees to comply with the study procedures and visits.

Exclusion Criteria:

1. Subject has a hypersensitivity to any of the ingredients of ospemifene
2. Subject has used ospemifene in the past
3. Subject has documented or suspected breast cancer, history of heart attack or stroke
4. Subject has clinically significant findings on physical examination
5. Subject has uncontrolled hypertension
6. Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study
7. Subject 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
8. Subject is currently on local or systemic estrogen therapy or androgen therapy (washout 14 days for vaginal estrogen, 60 days for oral/transdermal therapy)
9. Subject is currently using a Selective Estrogen Receptor Modulator (SERM) or products that have estrogenic or anti-estrogenic effects within last month
10. Subject currently using itraconazole, ketoconazole, digitalis or alkaloids heparin or strong cytochrome P 450 3A4 inhibitors
11. Subject has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week
12. Subject has received an investigational drug within 30 days prior to signing consent
13. Subject 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.

Primary outcomes:
measure: Visible Changes to the Vulva, Vestibule and Vaginal Region on Photography
timeFrame: Baseline and 20 weeks
Secondary outcomes:
measure: Changes in Pain Scale
timeFrame: Baseline and 20 weeks
measure: Percentage of Sexual Encounters in Which Pain Was Experienced
timeFrame: Baseline and 20 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
Study officials:
affiliation: San Diego Sexual Medicine
name: Irwin Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bachmann GA, Komi JO; Ospemifene Study Group. Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause. 2010 May-Jun;17(3):480-6. doi: 10.1097/gme.0b013e3181c1ac01.
citation: Portman DJ, Bachmann GA, Simon JA; Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013 Jun;20(6):623-30. doi: 10.1097/gme.0b013e318279ba64.
citation: Goldstein SR, Bachmann GA, Koninckx PR, Lin VH, Portman DJ, Ylikorkala O; Ospemifene Study Group. Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy. Climacteric. 2014 Apr;17(2):173-82. doi: 10.3109/13697137.2013.834493. Epub 2013 Nov 23.
citation: Simon JA, Lin VH, Radovich C, Bachmann GA; Ospemifene Study Group. One-year long-term safety extension study of ospemifene for the treatment of vulvar and vaginal atrophy in postmenopausal women with a uterus. Menopause. 2013 Apr;20(4):418-27. doi: 10.1097/gme.0b013e31826d36ba.
citation: Goldstein SW, Winter AG, Goldstein I. Improvements to the Vulva, Vestibule, Urethral Meatus, and Vagina in Women Treated With Ospemifene for Moderate to Severe Dyspareunia: A Prospective Vulvoscopic Pilot Study. Sex Med. 2018 Jun;6(2):154-161. doi: 10.1016/j.esxm.2018.03.002. Epub 2018 Apr 18.