Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA

NCT02784613 | Completed Phase 4 Results

• 1 other identifier: SDSM-2015-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvovaginal Atrophy; Dyspareunia

Outcome Measures

Primary Outcomes (1)

• Visible Changes to the Vulva, Vestibule and Vaginal Region on Photography

  Change in score on the Vulvoscopic Genital Tissue Appearance (VGTA) scale from baseline to 20 weeks was measured using ten parameters: 1) loss of labia majora, 2) loss of labia minora, 3) decreased glans clitoris, 4) prominence of the urethral meatus, 5) stenosis of the introitus, 6) vestibular pallor, 7) vestibular erythema, 8) loss of vestibular moisture, 9) loss of vaginal rugae, and 10) loss of prominence of the anterior vaginal wall to determine health of the vulva, vestibule and vaginal region using vulvoscopic photographs. VGTA scoring ranges from 0 (normal) to 3 (most severe) for each parameter, for a total score ranging from 0 (normal) to 30 (most severe). Each region assessed is reflected as worse for a higher score and better for a lower score in the 0-3 range, and the same for the total score, with 0 being the best possible score and 30 the worse.

  Baseline and 20 weeks

Secondary Outcomes (2)

• Changes in Pain Scale

  Baseline and 20 weeks

• Percentage of Sexual Encounters in Which Pain Was Experienced

  Baseline and 20 weeks

Study Arms (1)

Ospemifene open label

EXPERIMENTAL

60 mg ospemifene daily for 20 weeks

Drug: Ospemifene

Interventions

Ospemifene DRUG

FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia

Also known as: Osphena

Ospemifene open label

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject provides written informed consent and HIPAA authorization before any study procedures are conducted
• Subject is female
• Subject is aged 21-80 years
• Subject has a body mass index (BMI) \< 37 kg/m2
• 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
• Subject has vulvovaginal atrophy with dyspareunia
• Subject has had a normal mammogram within the last 6 months
• Subject has normal pap smear within last 6 months
• Subject has an endometrial stripe ≤ 4 mm within the last 6 months if she has a uterus
• Subject agrees to comply with the study procedures and visits.

You may not qualify if:

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

Sponsors & Collaborators

• Sue Goldstein: lead

Study Sites (1)

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

Related Publications (5)

• 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.

  PMID: 20032798 BACKGROUND

• 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.

  PMID: 23361170 BACKGROUND

• 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.

  PMID: 23984673 BACKGROUND

• 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.

  PMID: 23096251 BACKGROUND

• 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.

  PMID: 29678557 RESULT

MeSH Terms

Conditions

Dyspareunia

Interventions

Ospemifene

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Limitations and Caveats

Small pilot study size; open label without placebo; reader of vulvoscopic photographs was not involved in any part of data collection or subject visits but was aware of whether the photos were from baseline or end of study.

Results Point of Contact

• Title: Irwin Goldstein
• Organization: San Diego Sexual Medicine

dr.irwingoldstein@gmail.com

619-265-8865

Study Officials

• Irwin Goldstein, MD

  San Diego Sexual Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: May 27, 2016
• Study Start: July 1, 2015
• Primary Completion: February 7, 2017
• Study Completion: April 17, 2017
• Last Updated: April 2, 2019
• Results First Posted: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)