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

Primary Purpose

Vulvovaginal Atrophy, Dyspareunia

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ospemifene

About this trial

This is an interventional treatment trial for Vulvovaginal Atrophy

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

San Diego Sexual Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ospemifene open label

Arm Description

60 mg ospemifene daily for 20 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in Pain Scale

Changes in pain as noted on the pain scale (0-3) by q-tip testing of the vestibule by the clinician, with 0 representing no pain at the location and 3 being severe in each location, 1 o'clock, 3 o'clock, 5 o'clock, 6 o'clock, 7 o'clock, 9 o'clock and 11 o'clock circling the vestibule. The maximum total pain score range is 0 (no pain) to the worst score possible of 21 indicating severe pain at all locations.

Percentage of Sexual Encounters in Which Pain Was Experienced

For each sexual encounter, patients were required to record a ''yes" or "no" response to the following question: Did you experience pain during intercourse? The percentage of sexual encounters in which the woman answered "yes" to this question at baseline (first month of the study) and at week 20 (last month of the study) was compared. The worst score possible was experiencing pain during 100% of sexual encounters and the best possible score was experiencing pain during 0% of sexual encounters at any given assessment period.

Full Information

NCT ID

NCT02784613

First Posted

May 20, 2016

Last Updated

March 13, 2019

Sponsor

Sue Goldstein

1. Study Identification

Unique Protocol Identification Number

NCT02784613

Brief Title

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

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

February 7, 2017 (Actual)

Study Completion Date

April 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sue Goldstein

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vulvovaginal Atrophy, Dyspareunia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ospemifene open label

Arm Type

Experimental

Arm Description

60 mg ospemifene daily for 20 weeks

Intervention Type

Drug

Intervention Name(s)

Ospemifene

Other Intervention Name(s)

Osphena

Intervention Description

FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline and 20 weeks

Secondary Outcome Measure Information:

Title

Changes in Pain Scale

Description

Time Frame

Baseline and 20 weeks

Title

Percentage of Sexual Encounters in Which Pain Was Experienced

Description

Time Frame

Baseline and 20 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Irwin Goldstein, MD

Organizational Affiliation

San Diego Sexual Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Diego Sexual Medicine

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Information will be combined and not reported as individual participant data.

Citations:

PubMed Identifier

20032798

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.

Results Reference

background

PubMed Identifier

23361170

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.

Results Reference

background

PubMed Identifier

23984673

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.

Results Reference

background

PubMed Identifier

23096251

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.

Results Reference

background

PubMed Identifier

29678557

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.

Results Reference

result

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

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