Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 235 for:    PRASTERONE
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03568604
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
San Diego Sexual Medicine

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.

Condition or disease Intervention/treatment Phase
Dyspareunia Drug: Prasterone Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

Arm Intervention/treatment
Experimental: Prasterone
6.5 mg vaginal inserts of prasterone will be used daily once the patient meets inclusion and exclusion for 20 weeks.
Drug: Prasterone
6.5 vaginal insert prasterone (dehydroepiandrosterone)
Other Name: Intrarosa




Primary Outcome Measures :
  1. Vulvoscopic changes to the vulva, vestibule, urethral meatus and vaginal region on VGTA scale [ Time Frame: Twenty weeks ]
    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 :
  1. Changes in pain as noted on cotton-tipped swab (Q-tips®) test. [ Time Frame: Twenty weeks ]
    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.

  2. Subject diary [ Time Frame: Twenty weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568604


Contacts
Layout table for location contacts
Contact: Wendy Ramirez, BA 6192658865 wramirez@sdsm.info
Contact: JoAnna Williams, CCRC 6192658865 jwilliams@sdsm.info

Locations
Layout table for location information
United States, California
San Diego Sexual Medicine Recruiting
San Diego, California, United States, 92120
Contact: Sue W Goldstein, BA, CCRC    619-265-8865    suewgoldstein@gmail.com   
Contact: JoAnna Williams, CCRC    619-265-8865    jwilliams@sdsm.info   
Principal Investigator: Irwin Goldstein, MD         
Sponsors and Collaborators
San Diego Sexual Medicine
Investigators
Layout table for investigator information
Principal Investigator: Irwin Goldstein, MD San Diego Sexual Medicine
Study Director: Sue W Goldstein, BA, CCRC San Diego Sexual Medicine

Publications:

Layout table for additonal information
Responsible Party: San Diego Sexual Medicine
ClinicalTrials.gov Identifier: NCT03568604     History of Changes
Other Study ID Numbers: SDSM-2018-01
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by San Diego Sexual Medicine:
vulvovaginal atrophy
dyspareunia
prasterone
vulvoscopy
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyspareunia
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Mental Disorders
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs