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Trial record 7 of 235 for:    PRASTERONE

Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

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ClinicalTrials.gov Identifier: NCT02013544
Recruitment Status : Completed
First Posted : December 17, 2013
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
EndoCeutics Inc.

Brief Summary:
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.

Condition or disease Intervention/treatment Phase
Vaginal Atrophy Drug: Placebo Drug: Prasterone (DHEA) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo vaginal ovule daily for 12 weeks
Drug: Placebo
Experimental: Prasterone
Prasterone (DHEA) vaginal ovule daily for 12 weeks
Drug: Prasterone (DHEA)



Primary Outcome Measures :
  1. Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear [ Time Frame: Baseline and Week 12 ]
    The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

  2. Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear [ Time Frame: Baseline and Week 12 ]
    The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

  3. Change From Baseline to Week 12 in Vaginal pH [ Time Frame: Baseline and Week 12 ]
    A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

  4. Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia [ Time Frame: Baseline and Week 12 ]
    The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.


Secondary Outcome Measures :
  1. Change From Baseline to Week 12 in Severity of Vaginal Dryness [ Time Frame: Baseline and Week 12 ]
    The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

  2. Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions [ Time Frame: Baseline and Week 12 ]
    To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

  3. Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity [ Time Frame: Baseline and Week 12 ]
    To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

  4. Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness [ Time Frame: Baseline and Week 12 ]
    To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.

  5. Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color [ Time Frame: Baseline and Week 12 ]
    To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Main criteria:

  • Postmenopausal women (hysterectomized or not)
  • Women between 40 and 80 years of age
  • Women having ≤5% of superficial cells on vaginal smear at baseline
  • Women having a vaginal pH above 5 at baseline
  • Women who have self-identified moderate or severe symptom(s) of vaginal atrophy
  • Willing to participate in the study and sign an informed consent

Exclusion Criteria:

Main criteria:

  • Previous enrollment in EndoCeutics studies performed with intravaginal DHEA
  • Previous diagnosis of cancer, except skin cancer (non melanoma)
  • Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
  • The administration of any investigational drug within 30 days of screening visit
  • Clinically significant abnormal serum biochemistry, urinalysis or hematology

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): NCT02013544


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Sponsors and Collaborators
EndoCeutics Inc.
Investigators
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Study Chair: Fernand Labrie, M.D., Ph.D. EndoCeutics Inc.
Principal Investigator: David F Archer, M.D. Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA

Publications of Results:

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Responsible Party: EndoCeutics Inc.
ClinicalTrials.gov Identifier: NCT02013544     History of Changes
Other Study ID Numbers: ERC-238
First Posted: December 17, 2013    Key Record Dates
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017
Last Verified: May 2017
Keywords provided by EndoCeutics Inc.:
Vulvovaginal atrophy (VVA)
Vaginal atrophy
Atrophic vaginitis
prasterone
DHEA
Intrarosa
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs