Phase 3
Completed N=558
Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause
Source: ClinicalTrials.gov NCT02013544 ↗Enrolled (actual)
558
Serious AEs
0.9%
Results posted
Jun 2017
Primary outcomePrimary: Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear — 1.04; 1.02; 2.78; 11.22 Percentage of superficial cells
◆ Published Evidence
Highly cited
245citations · ~25 / year
Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause.
Summary
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.
Linked Publications (5)
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Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause.
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Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy.
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Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks.
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Serum levels of sex steroids and metabolites following 12 weeks of intravaginal 0.50% DHEA administration.
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Influence of treatment of vulvovaginal atrophy with intravaginal prasterone on the male partner.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear |
1.04; 1.02; 2.78; 11.22; 1.75; 10.20 | — |
| PRIMARY Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear |
51.66; 54.25; 39.68; 12.74; -11.98; -41.51 | — |
| PRIMARY Change From Baseline to Week 12 in Vaginal pH |
6.32; 6.34; 6.05; 5.39; -0.27; -0.94 | — |
| PRIMARY Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia |
2.56; 2.54; 1.50; 1.13; -1.06; -1.42 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Dryness |
2.30; 2.30; 1.13; 0.86; -1.17; -1.44 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions |
2.63; 2.70; 2.24; 1.97; -0.39; -0.73 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity |
2.43; 2.45; 2.06; 1.75; -0.37; -0.69 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness |
2.76; 2.83; 2.41; 2.09; -0.36; -0.74 | — |
| SECONDARY Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color |
2.67; 2.75; 2.34; 2.03; -0.33; -0.73 | — |
Eligibility Criteria
Inclusion Criteria
Main criteria:
- Postmenopausal women (hysterectomized or not)
- Women between 40 and 80 years of age
- Women having ≤5% of superficial cells on vaginal smear at baseline
- Women having a vaginal pH above 5 at baseline
- Women who have self-identified moderate or severe symptom(s) of vaginal atrophy
- Willing to participate in the study and sign an informed consent
Exclusion Criteria
Main criteria:
- Previous enrollment in EndoCeutics studies performed with intravaginal DHEA
- Previous diagnosis of cancer, except skin cancer (non melanoma)
- Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication
- The administration of any investigational drug within 30 days of screening visit
- Clinically significant abnormal serum biochemistry, urinalysis or hematology
Data sourced from ClinicalTrials.gov (NCT02013544) 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.