Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

Vaginal Atrophy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02013544
• Other study ID #: ERC-238
• Status: Completed
• Phase: Phase 3
• First received: December 9, 2013
• Last updated: May 30, 2017
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: May 2017
• Source: EndoCeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy

Intervention

Drug:
• Placebo

• Prasterone (DHEA)

Locations

Country	Name	City	State
Canada	EndoCeutics site # 85	Burlington	Ontario
Canada	EndoCeutics site # 69	Corunna	Ontario
Canada	EndoCeutics site # 04	Drummondville	Quebec
Canada	EndoCeutics site # 12	Montreal	Quebec
Canada	EndoCeutics site # 79	Pointe-Claire	Quebec
Canada	EndoCeutics site # 01	Quebec City	Quebec
Canada	EndoCeutics site # 02	Quebec City	Quebec
Canada	EndoCeutics site # 77	Quebec City	Quebec
Canada	EndoCeutics site # 78	Quebec City	Quebec
Canada	EndoCeutics site # 68	Sarnia	Ontario
Canada	EndoCeutics site # 74	Sherbrooke	Quebec
Canada	EndoCeutics site # 18	St-Romuald	Quebec
Canada	EndoCeutics site # 67	Victoriaville	Quebec
Canada	EndoCeutics site # 73	Waterloo	Ontario
United States	EndoCeutics site # 23	Atlanta	Georgia
United States	EndoCeutics site # 45	Boynton Beach	Florida
United States	EndoCeutics site # 05	Cleveland	Ohio
United States	EndoCeutics site # 15	Columbus	Ohio
United States	EndoCeutics site # 84	Corpus Christi	Texas
United States	EndoCeutics site # 36	Denver	Colorado
United States	EndoCeutics site # 52	Denver	Colorado
United States	EndoCeutics site # 82	Houston	Texas
United States	EndoCeutics site # 60	Lake Worth	Florida
United States	EndoCeutics site # 87	Lawrenceville	New Jersey
United States	EndoCeutics site # 86	Louisville	Kentucky
United States	EndoCeutics site # 27	Lutherville	Maryland
United States	EndoCeutics site # 39	Montgomery	Alabama
United States	EndoCeutics site # 03	Norfolk	Virginia
United States	EndoCeutics site # 54	North Miami	Florida
United States	EndoCeutics site # 75	Philadelphia	Pennsylvania
United States	EndoCeutics site # 81	Plainsboro	New Jersey
United States	EndoCeutics site # 21	Sacramento	California
United States	EndoCeutics site # 30	San Diego	California
United States	EndoCeutics site # 83	San Diego	California
United States	EndoCeutics site # 76	Seattle	Washington
United States	EndoCeutics site # 14	Tucson	Arizona
United States	EndoCeutics site # 80	West Palm Beach	Florida
United States	EndoCeutics site # 55	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
EndoCeutics Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (6)

Ke Y, Labrie F, Gonthier R, Simard JN, Bergeron D, Martel C, Vaillancourt M, Montesino M, Lavoie L, Archer DF, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group.. Serum levels of sex steroids and metabolites follow — View Citation

Labrie F, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Côté I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur É; VVA Prasterone Research Group.. Efficacy of intravaginal dehydroepiandrosterone — View Citation

Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Côté I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur É; Members of the VVA Prasterone Research Group.. Effect of Intravagin — View Citation

Labrie F, Montesino M, Archer DF, Lavoie L, Beauregard A, Côté I, Martel C, Vaillancourt M, Balser J, Moyneur E; other participating Members of the Prasterone Clinical Research Group.. Influence of treatment of vulvovaginal atrophy with intravaginal prast — View Citation

Martel C, Labrie F, Archer DF, Ke Y, Gonthier R, Simard JN, Lavoie L, Vaillancourt M, Montesino M, Balser J, Moyneur É; other participating members of the Prasterone Clinical Research Group.. Serum steroid concentrations remain within normal postmenopausa — View Citation

Montesino M, Labrie F, Archer DF, Zerhouni J, Côté I, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Moyneur E, Balser J. Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator. Gynecol Endocrinol. 2016;32(3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear	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.	Baseline and Week 12
Primary	Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear	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.	Baseline and Week 12
Primary	Change From Baseline to Week 12 in Vaginal pH	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.	Baseline and Week 12
Primary	Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia	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.	Baseline and Week 12
Secondary	Change From Baseline to Week 12 in Severity of Vaginal Dryness	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.	Baseline and Week 12
Secondary	Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions	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.	Baseline and Week 12
Secondary	Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity	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.	Baseline and Week 12
Secondary	Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness	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.	Baseline and Week 12
Secondary	Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color	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.	Baseline and Week 12