Phase 3
N=255
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
Vaginal Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT01256684 ↗Enrolled (actual)
255
Serious AEs
1.6%
Results posted
Apr 2017
Primary outcome: Primary: Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear — 68.48; 65.72; 65.05; 66.86 Percentage of parabasal cells
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); DHEA (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- EndoCeutics Inc.
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear |
68.48; 65.72; 65.05; 66.86; 28.43; 17.65 | — |
| PRIMARY Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear |
0.73; 0.68; 0.68; 1.64; 5.43; 6.30 | — |
| PRIMARY Change From Baseline to Week 12 in Vaginal pH |
6.51; 6.48; 6.47; 6.31; 5.70; 5.43 | — |
| PRIMARY Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia |
2.58; 2.56; 2.63; 1.71; 1.54; 1.36 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Dryness |
2.33; 2.20; 2.37; 1.32; 0.91; 0.92 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions |
2.78; 2.81; 2.83; 2.36; 2.10; 1.95 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity |
2.58; 2.57; 2.57; 2.13; 1.92; 1.69 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness |
2.91; 2.90; 2.89; 2.57; 2.32; 2.14 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color |
2.82; 2.94; 2.94; 2.56; 2.27; 2.05 | — |
Summary
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
Eligibility Criteria
Main Inclusion Criteria:
- Postmenopausal women (hysterectomized or 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.
- For non-hysterectomized women, willing to have endometrial biopsy at screening and end of study.
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.
Data sourced from ClinicalTrials.gov (NCT01256684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.