DHEA Against Vaginal Atrophy - Safety Study of 12 Months
- Registration Number
- NCT01256671
- Lead Sponsor
- EndoCeutics Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 530
- 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
- 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DHEA DHEA 0.5% DHEA (intravaginal)
- Primary Outcome Measures
Name Time Method Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels Baseline and Week 52 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.
Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium Baseline and Week 52 (or discontinuation) 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells). Baseline and Week 52 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.
Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). Baseline and Week 52 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.
Change From Baseline to Week 52 of Vaginal pH. Baseline and Week 52 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.
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia Baseline and Week 52 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.
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness Baseline and Week 52 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.
Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching Baseline and Week 52 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.
Trial Locations
- Locations (41)
EndoCeutics site # 25
🇺🇸Lincoln, Nebraska, United States
EndoCeutics site # 09
🇺🇸West Jordan, Utah, United States
EndoCeutics site # 13
🇨🇦Calgary, Alberta, Canada
EndoCeutics site # 12
🇨🇦Montreal, Quebec, Canada
EndoCeutics site # 02
🇨🇦Quebec City, Quebec, Canada
EndoCeutics site # 08
🇨🇦Shawinigan, Quebec, Canada
EndoCeutics site # 30
🇺🇸San Diego, California, United States
EndoCeutics site # 21
🇺🇸Sacramento, California, United States
EndoCeutics site # 39
🇺🇸Montgomery, Alabama, United States
EndoCeutics site # 17
🇺🇸San Diego, California, United States
EndoCeutics site # 23
🇺🇸Sandy Springs, Georgia, United States
EndoCeutics site # 19
🇺🇸New York, New York, 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 # 35
🇺🇸Pittsburgh, Pennsylvania, United States
EndoCeutics site # 31
🇺🇸Charlottesville, Virginia, United States
EndoCeutics site # 03
🇺🇸Norfolk, Virginia, United States
EndoCeutics site # 38
🇺🇸Renton, Washington, United States
EndoCeutics site # 36
🇺🇸Denver, Colorado, United States
EndoCeutics site # 16
🇺🇸Durham, North Carolina, United States
EndoCeutics site # 45
🇺🇸Boynton Beach, Florida, United States
EndoCeutics site # 41
🇺🇸West Palm Beach, Florida, United States
EndoCeutics site # 01
🇨🇦Quebec City, Quebec, Canada
EndoCeutics site # 18
🇨🇦St-Romuald, Quebec, Canada
EndoCeutics site # 06
🇨🇦Bathurst, New Brunswick, Canada
EndoCeutics site # 42
🇺🇸Milford, Connecticut, United States
EndoCeutics site # 27
🇺🇸Baltimore, Maryland, United States
EndoCeutics site # 28
🇺🇸Moorestown, New Jersey, United States
EndoCeutics site # 44
🇺🇸New Brunswick, New Jersey, United States
EndoCeutics site # 24
🇺🇸Omaha, Nebraska, United States
EndoCeutics site # 50
🇺🇸Neptune City, New Jersey, United States
EndoCeutics site # 22
🇺🇸Kalamazoo, Michigan, United States
EndoCeutics site # 07
🇺🇸Washington, D.C., District of Columbia, United States
EndoCeutics site # 34
🇨🇦Montreal, Quebec, Canada
EndoCeutics site # 26
🇺🇸Jacksonville, Florida, United States
EndoCeutics site # 11
🇨🇦Sherbrooke, Quebec, Canada
EndoCeutics site # 10
🇺🇸Meridian, Idaho, United States
EndoCeutics site # 04
🇨🇦Drummondville, Quebec, Canada
EndoCeutics site # 14
🇺🇸Tucson, Arizona, United States