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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
530
Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
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.
Time frame: Baseline and Week 52 (or discontinuation)
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.
Time frame: Baseline and Week 52
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.
Time frame: Baseline and Week 52
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.
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EndoCeutics site # 39
Montgomery, Alabama, United States
EndoCeutics site # 14
Tucson, Arizona, United States
EndoCeutics site # 21
Sacramento, California, United States
EndoCeutics site # 30
San Diego, California, United States
EndoCeutics site # 17
San Diego, California, United States
EndoCeutics site # 36
Denver, Colorado, United States
EndoCeutics site # 42
Milford, Connecticut, United States
EndoCeutics site # 07
Washington D.C., District of Columbia, United States
EndoCeutics site # 45
Boynton Beach, Florida, United States
EndoCeutics site # 26
Jacksonville, Florida, United States
...and 31 more locations
Time frame: Baseline and Week 52
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.
Time frame: Baseline and Week 52
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.
Time frame: Baseline and Week 52
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.
Time frame: Baseline and Week 52
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.
Time frame: Baseline and Week 52