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Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Pelvic Pain Suggestive of Dysmenorrhea: A Prospective, Multicenter, Double-Blind, Randomized Placebo-Controlled Study.

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 (average VAS ≥ 6/10 over the last 3 months), described as cramp-like, localized in the pelvic region, and similar to the initial dysmenorrhea pain.

• Having failed optimal first-line medical treatment combining hormonal therapy and appropriate analgesics (Level I and II analgesics, and NSAIDs),

• Having undergone a pelvic MRI within 1 year prior to the randomization visit that shows no evidence of deep infiltrating endometriosis or endometrioma, following systematic review by radiologists from the expert center managing the patient (if the pelvic MRI is deemed of insufficient quality for interpretation, a new MRI will be performed at the center),

• Using a highly effective method of contraception (failure rate \<1%) for the entire duration of the follow-up period. Highly effective contraception methods are defined as one of the following: combined hormonal contraception (containing estrogen and progestin) with ovulation inhibition (oral, vaginal, or transdermal), progestin-only hormonal contraception with ovulation inhibition (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormonal system (IUS), condoms, bilateral tubal occlusion, vasectomized partner, or sexual abstinence,

• Having a negative urine pregnancy test on the day of the procedure,

• Having signed the informed consent form for the study at the M-1 visit.

Locations
Other Locations
France
Clinique axium / Centre resilience
RECRUITING
Aix-en-provence
CHU Angers
RECRUITING
Angers
CHU Brest
RECRUITING
Brest
CHU Lille
RECRUITING
Lille
Hôpital de la Croix-Rousse
RECRUITING
Lyon
CHU Nantes
RECRUITING
Nantes
Clinique Brétéché
RECRUITING
Nantes
CHU Rennes
NOT_YET_RECRUITING
Rennes
Contact Information
Primary
Claire CARDAILLAC
claire.cardaillac@chu-nantes.fr
+33 2 53 48 23 50
Time Frame
Start Date: 2026-02-09
Estimated Completion Date: 2028-09-09
Participants
Target number of participants: 222
Treatments
Experimental: Botulinum toxin type A
One injection will be performed via hysteroscopy under local anesthesia. The patient will be followed up remotely at M1 and M6 to complete questionnaires, and will be seen in site at M3 for a postoperative consultation and to complete questionnaires.
Placebo_comparator: Placebo
One injection will be performed via hysteroscopy under local anesthesia. The patient will be followed up remotely at M1 and M6 to complete questionnaires, and will be seen in site at M3 for a postoperative consultation and to complete questionnaires.
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital
Collaborators: Merz Pharmaceuticals GmbH, Ministry of Health, France

This content was sourced from clinicaltrials.gov