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Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia

Primary Purpose

Dyspareunia

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Prasterone

About this trial

This is an interventional treatment trial for Dyspareunia focused on measuring vulvovaginal atrophy, dyspareunia, prasterone, vulvoscopy

Eligibility Criteria

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

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.

Sites / Locations

San Diego Sexual Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prasterone

Arm Description

6.5 mg vaginal inserts of prasterone will be used daily once the patient meets inclusion and exclusion for 20 weeks.

Outcomes

Primary Outcome Measures

Vulvoscopic changes to the vulva, vestibule, urethral meatus and vaginal region on VGTA scale

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 Outcome Measures

Changes in pain as noted on cotton-tipped swab (Q-tips®) test.

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

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.

Full Information

NCT ID

NCT03568604

First Posted

June 14, 2018

Last Updated

June 8, 2022

Sponsor

San Diego Sexual Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03568604

Brief Title

Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia

Official Title

Open-Label Vulvoscopy Photography Study of Changes in Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Administration of 6.5 Mg Vaginal Prasterone in Menopausal Women With Moderate to Severe Dyspareunia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

August 7, 2018 (Actual)

Primary Completion Date

January 28, 2020 (Actual)

Study Completion Date

January 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

San Diego Sexual Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Dyspareunia

Keywords

vulvovaginal atrophy, dyspareunia, prasterone, vulvoscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prasterone

Arm Type

Experimental

Arm Description

6.5 mg vaginal inserts of prasterone will be used daily once the patient meets inclusion and exclusion for 20 weeks.

Intervention Type

Drug

Intervention Name(s)

Prasterone

Other Intervention Name(s)

Intrarosa

Intervention Description

6.5 vaginal insert prasterone (dehydroepiandrosterone)

Primary Outcome Measure Information:

Title

Vulvoscopic changes to the vulva, vestibule, urethral meatus and vaginal region on VGTA scale

Description

Time Frame

Twenty weeks

Secondary Outcome Measure Information:

Title

Changes in pain as noted on cotton-tipped swab (Q-tips®) test.

Description

Time Frame

Twenty weeks

Title

Subject diary

Description

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.

Time Frame

Twenty 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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Irwin Goldstein, MD

Organizational Affiliation

San Diego Sexual Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sue W Goldstein, BA, CCRC

Organizational Affiliation

San Diego Sexual Medicine

Official's Role

Study Director

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

Individual participant data will not be shared with other researchers.

Citations:

PubMed Identifier

28640161

Citation

Labrie F, Archer DF, Martel C, Vaillancourt M, Montesino M. Combined data of intravaginal prasterone against vulvovaginal atrophy of menopause. Menopause. 2017 Nov;24(11):1246-1256. doi: 10.1097/GME.0000000000000910.

Results Reference

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PubMed Identifier

27997350

Citation

Labrie F, Martel C. A low dose (6.5 mg) of intravaginal DHEA permits a strictly local action while maintaining all serum estrogens or androgens as well as their metabolites within normal values. Horm Mol Biol Clin Investig. 2017 Feb 1;29(2):39-60. doi: 10.1515/hmbci-2016-0042.

Results Reference

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PubMed Identifier

26972555

Citation

Martel C, Labrie F, Archer DF, Ke Y, Gonthier R, Simard JN, Lavoie L, Vaillancourt M, Montesino M, Balser J, Moyneur E; other participating members of the Prasterone Clinical Research Group. Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks. J Steroid Biochem Mol Biol. 2016 May;159:142-53. doi: 10.1016/j.jsbmb.2016.03.016. Epub 2016 Mar 10.

Results Reference

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PubMed Identifier

26731686

Citation

Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Research Group. Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause. Menopause. 2016 Mar;23(3):243-56. doi: 10.1097/GME.0000000000000571.

Results Reference

background

PubMed Identifier

26725467

Citation

Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044.

Results Reference

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PubMed Identifier

26597311

Citation

Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.

Results Reference

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PubMed Identifier

25734980

Citation

Archer DF, Labrie F, Bouchard C, Portman DJ, Koltun W, Cusan L, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone). Menopause. 2015 Sep;22(9):950-63. doi: 10.1097/GME.0000000000000428.

Results Reference

background

PubMed Identifier

24774442

Citation

Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Gilbert L, Martel C, Balser J. Lack of influence of dyspareunia on the beneficial effect of intravaginal prasterone (dehydroepiandrosterone, DHEA) on sexual dysfunction in postmenopausal women. J Sex Med. 2014 Jul;11(7):1766-85. doi: 10.1111/jsm.12517. Epub 2014 Apr 28.

Results Reference

background

PubMed Identifier

23954500

Citation

Labrie F, Martel C, Berube R, Cote I, Labrie C, Cusan L, Gomez JL. Intravaginal prasterone (DHEA) provides local action without clinically significant changes in serum concentrations of estrogens or androgens. J Steroid Biochem Mol Biol. 2013 Nov;138:359-67. doi: 10.1016/j.jsbmb.2013.08.002. Epub 2013 Aug 14.

Results Reference

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Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia

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