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NCT07274956: DIENerveDens
Nerve Fiber Density in DIE Nodules & Pelvic Pain
trial in Deep Infiltrating Endometriosis, Pelvic Pain, Dysmenorrhea Dyspareunia in 65 participants. Completed in 27 June 2025.
27 June 2025
Quick facts
| Lead sponsor | Başakşehir Çam & Sakura City Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 65 |
| Start date | 1 February 2022 |
| Primary completion | 27 June 2025 |
| Estimated completion | 27 June 2025 |
| Sites | 2 locations across Turkey (Türkiye) |
Conditions studied
- Deep Infiltrating Endometriosis, Pelvic Pain, Dysmenorrhea Dyspareunia — all drugs for Deep Infiltrating Endometriosis, Pelvic Pain, Dysmenorrhea Dyspareunia →
Sponsor
Başakşehir Çam & Sakura City Hospital
Who can join
Adults 18 to 55, female only, with Deep Infiltrating Endometriosis, Pelvic Pain, Dysmenorrhea Dyspareunia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Deep infiltrating endometriosis (DIE) is a highly symptomatic form of endometriosis linked to severe dysmenorrhea, dyspareunia, dyschezia, dysuria, and chronic pelvic pain. Histologic studies suggest abundant neural elements in DIE nodules, but the relationship between nodule-level nerve fiber density and patient-reported pelvic pain remains insufficiently defined. This retrospective, cross-sectional study with prospective pathology re-review evaluates whether nerve fiber density in surgically excised DIE nodules correlates with pain severity and location. Women aged 18-55 who underwent surgery for DIE after inadequate response to medical therapy are included. Clinical data (demographics, gynecologic history, prior treatments) and standardized pain scores (VAS for pain domains) are abstracted from records. Archived blocks are recut; sections are stained with H\&E and immunolabeled (e.g., SOX-10) to quantify neural profiles and derive a nerve fiber density metric per nodule. Primary endpoint: association between nerve fiber density and pain intensity/localization. Secondary endpoints: relationships with lesion site/depth and other clinicopathologic variables; exploratory discrimination of severe-pain phenotypes. Statistics (χ²/Fisher, t/Mann-Whitney, Kaplan-Meier/Cox if applicable) use two-sided p\<0.05. This minimal-risk study uses existing records and archived tissue only; findings may inform counseling, nerve-sparing surgical planning, and future biomarker-driven, response-adapted trials.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07274956 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Başakşehir Çam & Sakura City Hospital
- Last refreshed: 10 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07274956.
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