(124) An Open-Label, Vulvoscopic Pilot Study of Intravaginal Prasterone in Menopausal Women with Dyspareunia Examining Vestibular Tissue Changes
Bibliographic record
Abstract
Abstract Introduction Prasterone (DHEA), a daily 6.5 mg intravaginal insert, is approved in the US and Canada for moderate to severe dyspareunia, a symptom of vulvovaginal atrophy from menopause. Prasterone converts intracellularly in vaginal epithelial cells into active androgens and estrogens without affecting systemic hormone blood levels. Although prasterone is a vaginal insert, the significant reduction of pain in the phase 3 registration trials suggests improvement of the vestibular endodermal genital tissue health associated with dyspareunia in androgen and estrogen deficient states like menopause. To the best of our knowledge, there have not been previous prospective studies documenting visible changes to the vestibule with daily administration of 6.5 mg prasterone in menopausal women with vulvovaginal atrophy and moderate to severe dyspareunia. Objective It is the aim of this study to investigate whether an intravaginal therapy, prasterone, could affect the vestibular tissue, assessing for changes in visual appearance, pain, and responses on sexual event diaries over the 20-week administration of intravaginal 6.5 mg prasterone. Methods This 20-week, open-label, prospective, pilot study included 11 menopausal women (median age = 56 y) treated daily with 6.5 mg prasterone intravaginal inserts and assessed every 4 weeks. During vulvoscopy, vestibular pain was assessed by cotton-tipped swab testing and vestibular and vaginal health were independently assessed using the Visual Scale (VS). In addition, vulvoscopic photographs were obtained and assessed using the Vulvoscopic Genital Tissue Appearance (VGTA) scale to evaluate overall genital tissue health. Mean changes from baseline for genital tissue health and pain assessments were analyzed by repeated measures one-way analysis of variance, followed by Dunnett’s post-hoc test. Sexual event diaries were completed, and adverse events recorded. Results Eleven participants completed the study, with a total of 1607 vulvoscopic photographs, showing reduction in vestibular erythema and pallor at end of study. Total VGTA scores at week 20 showed improvement from baseline (mean change = -7.9, p = 0.0016). Changes in VS scores were significantly reduced from baseline after active treatment by week 4 and maintained through week 20 for the vestibule (3.00, p = 0.004) and vagina (4.00, p = 0.002) respectively), suggesting improved vestibular and vaginal tissue health. Cotton-tipped swab test scores were significantly reduced from baseline after week 8 through week 20 (mean change = (-7.27, p = 0.019), suggesting decreased pain. Diary results showed decrease in pain from 81.3% during the first month to 8.3% during the last month of the study, with sexual activities discontinued due to discomfort reduced from 45.8% to 6.3% respectively. No prasterone related adverse events were reported. Conclusions This is the first prospective vulvoscopic study showing that intravaginal hormone therapy significantly improves total VGTA, VS and cotton-tipped swab test scores. This observation may explain the robust effect of prasterone in lowering dyspareunia in menopausal women with moderate to severe dyspareunia. Our findings suggest that intravaginal prasterone exerts biologic activity on the androgenic endodermal vestibule, as the medication passes from vagina to vestibule, resulting in amelioration of pain associated with sexual activity. Disclosure Yes, this is sponsored by industry/sponsor: AMAG Pharmaceuticals, Inc. Clarification: Industry funding only - investigator initiated and executed study.
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How this classification was reachedexpand
Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | no category Domain: not available · Genre: Empirical About the Canadian research system: no · About a Canadian topic: no | Non-randomized trial | low |
| gpt | no category Domain: not available · Genre: Empirical About the Canadian research system: no · About a Canadian topic: no | Bench or experimental | low |
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedLabeled directly by 2 models reading the full record.
The models disagree on parts of this classification; every voice is preserved in the section at the end of the page.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".