Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
- Registration Number
- NCT01358760
- Lead Sponsor
- EndoCeutics Inc.
- Brief Summary
The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 450
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - 0.25% DHEA DHEA - 0.5% DHEA DHEA -
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear 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.
Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Baseline and Week 12 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.
Change From Baseline to Week 12 in Vaginal pH 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.
Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity 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.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness 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.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color 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.
Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions 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.
Change From Baseline to Week 12 in Severity of Dyspareunia 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.
Trial Locations
- Locations (42)
EndoCeutics site # 66
🇺🇸Danbury, Connecticut, United States
EndoCeutics site # 27
🇺🇸Baltimore, Maryland, United States
EndoCeutics site # 15
🇺🇸Columbus, Ohio, United States
EndoCeutics site # 09
🇺🇸West Jordan, Utah, United States
EndoCeutics site # 59
🇨🇦Toronto, Ontario, Canada
EndoCeutics site # 39
🇺🇸Montgomery, Alabama, United States
EndoCeutics site # 42
🇺🇸Milford, Connecticut, United States
EndoCeutics site # 56
🇺🇸Pinellas Park, Florida, United States
EndoCeutics site # 10
🇺🇸Meridian, Idaho, United States
EndoCeutics site # 64
🇺🇸Jackson, Tennessee, United States
EndoCeutics site # 51
🇺🇸Sandy City, Utah, United States
EndoCeutics site # 08
🇨🇦Shawinigan, Quebec, Canada
EndoCeutics site # 30
🇺🇸San Diego, California, United States
EndoCeutics site # 21
🇺🇸Sacramento, California, United States
EndoCeutics site # 23
🇺🇸Sandy Springs, Georgia, United States
EndoCeutics site # 05
🇺🇸Cleveland, Ohio, United States
EndoCeutics site # 47
🇺🇸Cleveland, Ohio, United States
EndoCeutics site # 62
🇺🇸Providence, Rhode Island, United States
EndoCeutics site # 53
🇺🇸San Antonio, Texas, United States
EndoCeutics site # 33
🇺🇸Beachwood, Ohio, United States
EndoCeutics site # 03
🇺🇸Norfolk, Virginia, United States
EndoCeutics site # 36
🇺🇸Denver, Colorado, United States
EndoCeutics site # 55
🇺🇸Wichita, Kansas, United States
EndoCeutics site # 52
🇺🇸Denver, Colorado, United States
EndoCeutics site # 06
🇨🇦Bathurst, New Brunswick, Canada
EndoCeutics site # 61
🇺🇸Newark, Delaware, United States
EndoCeutics site # 60
🇺🇸Lake Worth, Florida, United States
EndoCeutics site # 63
🇺🇸Memphis, Tennessee, United States
EndoCeutics site # 54
🇺🇸North Miami, Florida, United States
EndoCeutics site # 01
🇨🇦Quebec City, Quebec, Canada
EndoCeutics site # 13
🇨🇦Calgary, Alberta, Canada
EndoCeutics site # 12
🇨🇦Montreal, Quebec, Canada
EndoCeutics site # 57
🇺🇸West Hartford, Connecticut, United States
EndoCeutics site # 18
🇨🇦St-Romuald, Quebec, Canada
EndoCeutics site # 14
🇺🇸Tucson, Arizona, United States
EndoCeutics site # 50
🇺🇸Neptune City, New Jersey, United States
EndoCeutics site # 11
🇨🇦Sherbrooke, Quebec, Canada
EndoCeutics site # 02
🇨🇦Quebec City, Quebec, Canada
EndoCeutics site # 65
🇺🇸Little Rock, Arkansas, United States
EndoCeutics site # 26
🇺🇸Jacksonville, Florida, United States
EndoCeutics site # 24
🇺🇸Omaha, Nebraska, United States
EndoCeutics site # 04
🇨🇦Drummondville, Quebec, Canada