Phase 3
Completed N=255
DHEA Against Vaginal Atrophy - 3-Month Efficacy Study
Source: ClinicalTrials.gov NCT01256684 ↗Enrolled (actual)
255
Serious AEs
1.6%
Results posted
Apr 2017
Primary outcomePrimary: 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
◆ Published Evidence
Highly cited
104citations · ~9 / year
Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone).
Summary
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
Linked Publications (3)
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Treatment of pain at sexual activity (dyspareunia) with intravaginal dehydroepiandrosterone (prasterone).
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Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women.
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Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks.
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 | — |
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) 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.