Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy

Vaginal Atrophy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358760
• Other study ID #: ERC-234
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2011
• Last updated: June 8, 2017
• Start date: June 2011
• Est. completion date: May 2012

Study information

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

Clinical Trial Summary

The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Postmenopausal women (non-hysterectomized or hysterectomized)

• Women between 40 and 75 years of age

• Willing to participate in the study and sign an informed consent

• Women who have self-identified symptom(s) of vaginal atrophy

• For non-hysterectomized women, willing to have endometrial biopsy at baseline and end of study

Exclusion Criteria:

• Undiagnosed abnormal genital bleeding

• Hypertension equal to or above 140/90 mm Hg

• The administration of any investigational drug within 30 days of screening visit

• Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening

Related Conditions & MeSH terms

• Atrophy
• Vaginal Atrophy

Intervention

Drug:
• Placebo
Placebo vaginal suppository
• DHEA
Vaginal suppository containing 0.25% (3.25 mg) DHEA
• DHEA
Vaginal suppository containing 0.5% (6.5 mg) DHEA

Locations

Country	Name	City	State
Canada	EndoCeutics site # 06	Bathurst	New Brunswick
Canada	EndoCeutics site # 13	Calgary	Alberta
Canada	EndoCeutics site # 04	Drummondville	Quebec
Canada	EndoCeutics site # 12	Montreal	Quebec
Canada	EndoCeutics site # 01	Quebec City	Quebec
Canada	EndoCeutics site # 02	Quebec City	Quebec
Canada	EndoCeutics site # 08	Shawinigan	Quebec
Canada	EndoCeutics site # 11	Sherbrooke	Quebec
Canada	EndoCeutics site # 18	St-Romuald	Quebec
Canada	EndoCeutics site # 59	Toronto	Ontario
United States	EndoCeutics site # 27	Baltimore	Maryland
United States	EndoCeutics site # 33	Beachwood	Ohio
United States	EndoCeutics site # 05	Cleveland	Ohio
United States	EndoCeutics site # 47	Cleveland	Ohio
United States	EndoCeutics site # 15	Columbus	Ohio
United States	EndoCeutics site # 66	Danbury	Connecticut
United States	EndoCeutics site # 36	Denver	Colorado
United States	EndoCeutics site # 52	Denver	Colorado
United States	EndoCeutics site # 64	Jackson	Tennessee
United States	EndoCeutics site # 26	Jacksonville	Florida
United States	EndoCeutics site # 60	Lake Worth	Florida
United States	EndoCeutics site # 65	Little Rock	Arkansas
United States	EndoCeutics site # 63	Memphis	Tennessee
United States	EndoCeutics site # 10	Meridian	Idaho
United States	EndoCeutics site # 42	Milford	Connecticut
United States	EndoCeutics site # 39	Montgomery	Alabama
United States	EndoCeutics site # 50	Neptune City	New Jersey
United States	EndoCeutics site # 61	Newark	Delaware
United States	EndoCeutics site # 03	Norfolk	Virginia
United States	EndoCeutics site # 54	North Miami	Florida
United States	EndoCeutics site # 24	Omaha	Nebraska
United States	EndoCeutics site # 56	Pinellas Park	Florida
United States	EndoCeutics site # 62	Providence	Rhode Island
United States	EndoCeutics site # 21	Sacramento	California
United States	EndoCeutics site # 53	San Antonio	Texas
United States	EndoCeutics site # 30	San Diego	California
United States	EndoCeutics site # 51	Sandy City	Utah
United States	EndoCeutics site # 23	Sandy Springs	Georgia
United States	EndoCeutics site # 14	Tucson	Arizona
United States	EndoCeutics site # 57	West Hartford	Connecticut
United States	EndoCeutics site # 09	West Jordan	Utah
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 (2)

Bouchard C, Labrie F, Archer DF, Portman DJ, Koltun W, Elfassi É, Grainger DA, Ayotte N, Cooper TA, Martens M, Waldbaum AS, Labrie C, Côté I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Decreased efficacy of twice-weekly intravaginal dehydroepiand — View Citation

Portman DJ, Labrie F, Archer DF, Bouchard C, Cusan L, Girard G, Ayotte N, Koltun W, Blouin F, Young D, Wade A, Martel C, Dubé R; other participating members of VVA Prasterone Group. Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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 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 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 Vaginal Dryness	The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of 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 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 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