Vulvovaginal AtrophyPhase 4NCT02784613

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

A Phase 4 study testing Ospemifene in people with Vulvovaginal Atrophy and Dyspareunia, run by Sue Goldstein at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 80 years, women only
Conditions the study is for: Vulvovaginal Atrophy, Dyspareunia
What is being tested?: Ospemifene
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Jul 2015to 17 Apr 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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.

Who cannot join

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

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

San Diego Sexual Medicine
San Diego, California, 92120

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Vulvovaginal Atrophy, Dyspareunia
Being tested: Ospemifene
Medical subject headings: Dyspareunia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OspemifeneDrug
Also called Osphena
FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia

Study groups in NCT02784613
Study group	Role	What they receive
Ospemifene open label	Experimental	60 mg ospemifene daily for 20 weeks Receives: Drug: Ospemifene

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 20 weeks

Secondary outcomes (2)

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.
Measured: Baseline and 20 weeks
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.
Measured: Baseline and 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201517 Apr 2017

First posted27 May 2016 (estimated)
Study startJul 2015
Primary completion7 Feb 2017
Study completion17 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Vulvovaginal AtrophyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02784613
Sponsor's protocol ID: SDSM-2015-02
Status last verified: Mar 2019
First submitted: 20 May 2016
Last updated: 2 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Information will be combined and not reported as individual participant data.

Publications

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.
PubMed 20032798
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.
PubMed 23361170
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.
PubMed 23984673
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.
PubMed 23096251
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.
PubMed 29678557

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer

All Vulvovaginal Atrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02784613
Acronym / sponsor ID: SDSM-2015-02
Conditions: Vulvovaginal Atrophy, Dyspareunia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Sue GoldsteinUniversity, hospital or other
Study start: Jul 2015
Primary completion: 7 Feb 2017 (actual)
Study completion: 17 Apr 2017 (actual)
First posted: 27 May 2016 (estimated)
Results: Posted 2 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ospemifene open label	Experimental	Drug: Ospemifene60 mg ospemifene daily for 20 weeks

Who may qualify

Ages: 21 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OspemifeneAlso: OsphenaFDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia	Drug	Ospemifene open label

Primary outcome

Visible Changes to the Vulva, Vestibule and Vaginal Region on Photography
Time frame: Baseline and 20 weeks
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.

2 secondary outcomes

Changes in Pain Scale
Time frame: Baseline and 20 weeks
Percentage of Sexual Encounters in Which Pain Was Experienced
Time frame: Baseline and 20 weeks

Results and safety

Results posted to the registry on 2 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ospemifene Open Label	10	8

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

Time frame: Baseline and 20 weeks. Median (Inter-Quartile Range). Unit: points improvement on VGTA scale

Measure	Open Label n = 8
Value	8 (7 to 8)

Open Label: p = 0.05, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months per participant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open Label	0 of 8 (0%)	4 of 8 (50%)	0 of 8

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20032798Bachmann 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.
Background: PubMed 23361170Portman 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.
Background: PubMed 23984673Goldstein 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.
Background: PubMed 23096251Simon 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 publication: PubMed 29678557Goldstein 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.
Individual participant dataSharing planned: No. Information will be combined and not reported as individual participant data.

Related trials for Vulvovaginal Atrophy

RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
Recruiting
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Female Urogenital Diseases, Breast Cancer Female
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
RecruitingObservational study
Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors
Genitourinary Syndrome of Menopause (GSM), Breast Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Irwin Goldstein, MD principal investigator

San Diego Sexual Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ospemifene in people with Vulvovaginal Atrophy and Dyspareunia, run by Sue Goldstein at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visible Changes to the Vulva, Vestibule and Vaginal Region on Photography (time frame: Baseline and 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02784613, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.