Phase 3
Completed N=450
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
Source: ClinicalTrials.gov NCT01358760 ↗Enrolled (actual)
450
Serious AEs
1.6%
Results posted
Jun 2017
Primary outcomePrimary: Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear — 60.66; 56.74; 59.54; 62.22 percentage of parabasal cells
◆ Published Evidence
Established
90citations · ~8 / year
Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women.
Summary
The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
Linked Publications (2)
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Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women.
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Decreased efficacy of twice-weekly intravaginal dehydroepiandrosterone on vulvovaginal atrophy.
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 |
60.66; 56.74; 59.54; 62.22; 39.23; 33.02 | — |
| PRIMARY Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear |
0.97; 1.12; 0.93; 1.80; 3.43; 3.58 | — |
| PRIMARY Change From Baseline to Week 12 in Vaginal pH |
6.34; 6.27; 6.29; 6.06; 5.69; 5.67 | — |
| PRIMARY Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness |
2.38; 2.37; 2.35; 1.27; 1.10; 1.13 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Dyspareunia |
2.56; 2.58; 2.60; 1.78; 1.48; 1.54 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions |
2.71; 2.55; 2.55; 2.33; 2.07; 2.07 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity |
2.32; 2.19; 2.19; 1.94; 1.74; 1.69 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness |
2.78; 2.66; 2.72; 2.40; 2.25; 2.16 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color |
2.66; 2.60; 2.65; 2.31; 2.16; 2.12 | — |
Eligibility Criteria
Inclusion Criteria
- 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
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 (NCT01358760) and the linked publication. 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. Informational only — not medical advice.