Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Pelvic Pain Suggestive of Dysmenorrhea

Recruiting Phase 3 Interventional Study
Primary Dysmenorrhea Chronic Pelvic Pain
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
222 (estimated)
Sponsor
Nantes University Hospital · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Adult women who are not menopausal, * Presenting with: * Either severe primary dysmenorrhea, defined by an average pain intensity (VAS) ≥ 6/10 over the last 3 months at the inclusion visit, * Or, in cases of amenorrhea under hormonal treatment, severe chronic pelvic pain (aver…
Contacts

Claire CARDAILLAC

+33 2 53 48 23 50

claire.cardaillac@chu-nantes.fr

CONTACT