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NCT06995287: HYSTEROXINE
Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea
Phase 3 trial testing Xeomin in Primary Dysmenorrhea in 222 participants. Currently enrolling.
9 June 2028
Quick facts
| Lead sponsor | Nantes University Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 222 |
| Start date | 9 February 2026 |
| Primary completion | 9 June 2028 |
| Estimated completion | 9 September 2028 |
| Sites | 8 locations across France |
Drugs / interventions tested
- Xeomin (INCOBOTULINUMTOXINA) — full drug profile →
- Placebo
Conditions studied
- Primary Dysmenorrhea — all drugs for Primary Dysmenorrhea →
- Chronic Pelvic Pain — all drugs for Chronic Pelvic Pain →
Sponsor
Nantes University Hospital
Who can join
18 and older, female only, with Primary Dysmenorrhea or Chronic Pelvic Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of the study is to evaluate the global impression of improvement at 3 months following intramyometrial botulinum toxin injections via hysteroscopy in women with severe primary dysmenorrhea who have failed first-line medical treatment, compared to intramyometrial placebo injections.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06995287
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Xeomin
Trials testing the same drug.
- NCT05980559 — Evaluation of BTX Injections in Treatment of Bruxism · Phase 3 · unknown
- NCT04102670 — Combination Therapy for Rejuvenation of the Lower Face and Neck · NA · unknown
- NCT03977493 — IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia · Phase 3 · recruiting
Other recruiting trials for Primary Dysmenorrhea
Currently open trials in the same condition.
- NCT07409337 — Self-Acupressure for Primary Dysmenorrhea and Premenstrual Symptoms · NA · recruiting
- NCT07352982 — Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea · NA · recruiting
- NCT07239232 — "Knee Joint Position Sense and Dynamic Balance in Females With Primary Dysmenorrhea · recruiting
- NCT07314021 — Primary Dysmenorrhea and Mobilization. · NA · active not recruiting
- NCT07095725 — Effect of Primary Dysmenorrhea on Muscle Activity in Young Adult Females · recruiting
Other Nantes University Hospital trials
Trials by the same sponsor.
- NCT07278661 — Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. · Phase 2 · recruiting
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- NCT07467382 — GOAT (Gait Observation of Achilles Tendon) · not yet recruiting
- NCT07490379 — Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients Wi · NA · not yet recruiting
- NCT07423481 — Weight Trajectories and Predictive Factors After Semaglutide in Patients With Grade 3 and Complicated Obesity · not yet recruiting
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 NCT06995287 (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 Nantes University Hospital
- Last refreshed: 12 February 2026
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/NCT06995287.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing