Phase 3
Completed N=218
Topical DHEA Against Vaginal Atrophy
Source: ClinicalTrials.gov NCT01846442 ↗Enrolled (actual)
218
Serious AEs
0.9%
Results posted
Apr 2017
Primary outcomePrimary: Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) — 46.7; 65.5; 53.4; 61.8 percentage of parabasal cells
◆ Published Evidence
Highly cited
190citations · ~11 / year
Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women.
Summary
The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.
Linked Publications (5)
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Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women.
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Intravaginal dehydroepiandrosterone (Prasterone), a physiological and highly efficient treatment of vaginal atrophy.
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Serum steroid levels during 12-week intravaginal dehydroepiandrosterone administration.
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Intravaginal dehydroepiandrosterone (prasterone), a highly efficient treatment of dyspareunia.
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High internal consistency and efficacy of intravaginal DHEA for vaginal atrophy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells) |
46.7; 65.5; 53.4; 61.8; 47.8; 16.9 | — |
| PRIMARY Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells) |
0.6; 0.4; 0.4; 0.4; 0.5; 5.7 | — |
| PRIMARY Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH. |
6.5; 6.6; 6.6; 6.5; 6.0; 5.5 | — |
| PRIMARY Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia |
2.8; 2.8; 2.7; 2.6; 2.3; 1.4 | — |
| SECONDARY Change From Baseline to Week 12 of Vaginal Secretions |
3.1; 3.1; 3.2; 3.0; 2.7; 1.9 | — |
| SECONDARY Change From Baseline to Week 12 of Vaginal Epithelial Integrity |
2.8; 2.7; 2.8; 2.7; 2.4; 1.7 | — |
| SECONDARY Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness |
3.0; 2.9; 3.1; 3.0; 2.6; 1.9 | — |
| SECONDARY Change From Baseline to Week 12 of Vaginal Color |
3.1; 3.0; 3.1; 3.1; 2.7; 2.0 | — |
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 having a low maturation index (no greater part of guidance than 5% of superficial cells on vaginal smear)
- Women having a vaginal pH above 5
- Women who have self-identified at least one moderate to severe symptoms of vulvovaginal atrophy
Exclusion Criteria
- Undiagnosed abnormal genital bleeding
- Hypertension equal to or above 160/95 mm Hg or not controlled by standard therapy
- The administration of any investigational drug within 30 days of screening visit
- Endometrial hyperplasia at biopsy performed at screening or endometrial cancer
- Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc) in the 4 weeks to 6 months (depending on the product used) prior study entry
Data sourced from ClinicalTrials.gov (NCT01846442) 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.