143 Randomized, Double-blind, Placebo-Controlled Multicenter Study to Evaluate Efficacy and Safety of Ospemifene in Patients with Moderate to Severe Vaginal Dryness, Including Evaluation of Vulvar Health by Photographic Images
Bibliographic record
Abstract
Vulvovaginal atrophy (VVA), a symptom of genitourinary syndrome of menopause, results from atrophy of vaginal epithelium. Ospemifene, an oral, selective estrogen receptor modulator, was evaluated in a phase 3 clinical trial in postmenopausal women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA. Vulvar photography was used as an innovative assessment of vulvar health. The objective was to demonstrate safety and efficacy of 60mg ospemifene daily in treatment of vaginal dryness due to VVA. Photographic assessments of VVA performed during this study are reported herein. Postmenopausal women age 40-80 with moderate to severe vaginal dryness as MBS of VVA were randomized 1:1 to ospemifene 60 mg or placebo daily. Co-primary efficacy endpoints included change from baseline to week 12 in parabasal/superficial cells, vaginal pH, severity of vaginal dryness. Secondary endpoints were vaginal health index (VHI), vulvar health index (VuHI), and optional vulvovaginal photographic imaging assessment of clitoris size, labia majora/minora loss, urethral glans prominence, introital stenosis/pallor/ erythema/moisture, mucosal inflammation, and other findings including petechiae, excoriation, and ulceration.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
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, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".