DHEA Against Vaginal Atrophy - Safety Study of 12 Months

Vaginal Atrophy Clinical Trial

Official title:

DHEA Against Vaginal Atrophy - Safety Study of 12 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256671
• Other study ID #: ERC-230
• Status: Completed
• Phase: Phase 3
• First received: December 3, 2010
• Last updated: September 15, 2017
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: September 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 assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

Main Inclusion Criteria:

• Postmenopausal women (non-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.

• Willing to have endometrial biopsy at screening and end of study (Week 52).

Main 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:
• DHEA
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.

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 # 34	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
United States	EndoCeutics site # 27	Baltimore	Maryland
United States	EndoCeutics site # 33	Beachwood	Ohio
United States	EndoCeutics site # 45	Boynton Beach	Florida
United States	EndoCeutics site # 31	Charlottesville	Virginia
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 # 36	Denver	Colorado
United States	EndoCeutics site # 16	Durham	North Carolina
United States	EndoCeutics site # 26	Jacksonville	Florida
United States	EndoCeutics site # 22	Kalamazoo	Michigan
United States	EndoCeutics site # 25	Lincoln	Nebraska
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 # 28	Moorestown	New Jersey
United States	EndoCeutics site # 50	Neptune City	New Jersey
United States	EndoCeutics site # 44	New Brunswick	New Jersey
United States	EndoCeutics site # 19	New York	New York
United States	EndoCeutics site # 03	Norfolk	Virginia
United States	EndoCeutics site # 24	Omaha	Nebraska
United States	EndoCeutics site # 35	Pittsburgh	Pennsylvania
United States	EndoCeutics site # 38	Renton	Washington
United States	EndoCeutics site # 21	Sacramento	California
United States	EndoCeutics site # 17	San Diego	California
United States	EndoCeutics site # 30	San Diego	California
United States	EndoCeutics site # 23	Sandy Springs	Georgia
United States	EndoCeutics site # 14	Tucson	Arizona
United States	EndoCeutics site # 07	Washington, D.C.	District of Columbia
United States	EndoCeutics site # 09	West Jordan	Utah
United States	EndoCeutics site # 41	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
EndoCeutics Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (5)

Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Côté I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on — View Citation

Ke Y, Gonthier R, Simard JN, Archer D, Lavoie L, Martel C, Vaillancourt M, Labrie F. Serum steroids remain within the same normal postmenopausal values during 12-month intravaginal 0.50% DHEA. Horm Mol Biol Clin Investig. 2015 Dec;24(3):117-29. doi: 10.15 — View Citation

Labrie F, Archer DF, Bouchard C, Girard G, Ayotte N, Gallagher JC, Cusan L, Baron M, Blouin F, Waldbaum AS, Koltun W, Portman DJ, Côté I, Lavoie L, Beauregard A, Labrie C, Martel C, Balser J, Moyneur É; Members of the VVA Prasterone Group. Prasterone has — 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 postmenopausal — 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	Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium	The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.	Baseline and Week 52 (or discontinuation)
Primary	Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels	The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.	Baseline and Week 52
Secondary	Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells).	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 52 as well as the change from Baseline to Week 52 are presented.	Baseline and Week 52
Secondary	Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells).	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 52 as well as the change from Baseline to Week 52 are presented.	Baseline and Week 52
Secondary	Change From Baseline to Week 52 of 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 52 as well as the change from Baseline to Week 52 are presented.	Baseline and Week 52
Secondary	Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia	The severity of dyspareunia was evaluated by a questionnaire. 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 52 as well as the change from Baseline to Week 52 are presented.	Baseline and Week 52
Secondary	Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness	The severity of vaginal dryness was evaluated by a questionnaire. 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 52 as well as the change from Baseline to Week 52 are presented.	Baseline and Week 52
Secondary	Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching	The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching 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 52 as well as the change from Baseline to Week 52 are presented.	Baseline and Week 52