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

NCT03568604 | Completed Phase 4 FDA Drug

• 1 other identifier: SDSM-2018-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspareunia

Keywords

vulvovaginal atrophy; dyspareunia; prasterone; vulvoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  Twenty weeks

Secondary Outcomes (2)

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

  Twenty weeks

• Subject diary

  Twenty weeks

Study Arms (1)

Prasterone

EXPERIMENTAL

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

Drug: Prasterone

Interventions

Prasterone DRUG

6.5 vaginal insert prasterone (dehydroepiandrosterone)

Also known as: Intrarosa

Prasterone

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Diego Sexual Medicine: lead

Study Sites (1)

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

Related Publications (9)

• 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.

  PMID: 28640161 BACKGROUND

• 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.

  PMID: 27997350 BACKGROUND

• 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.

  PMID: 26972555 BACKGROUND

• 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.

  PMID: 26731686 BACKGROUND

• 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.

  PMID: 26725467 BACKGROUND

• 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.

  PMID: 26597311 BACKGROUND

• 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.

  PMID: 25734980 BACKGROUND

• 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.

  PMID: 24774442 BACKGROUND

• 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.

  PMID: 23954500 BACKGROUND

MeSH Terms

Conditions

Dyspareunia

Interventions

Dehydroepiandrosterone

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

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Irwin Goldstein, MD

  San Diego Sexual Medicine

  PRINCIPAL INVESTIGATOR

• Sue W Goldstein, BA, CCRC

  San Diego Sexual Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: August 7, 2018
• Primary Completion: January 28, 2020
• Study Completion: January 28, 2020
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)