Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-09

Study Completion Date

2028-09-09

Brief Summary

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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.

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Detailed Description

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This trial is multicenter, placebo-controlled, randomized with center-based stratification, double-blind and prospective. The treatment consists of a single injection follow by 6 months of follow-up.

Conditions

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Primary Dysmenorrhea Chronic Pelvic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Xeomin

Intervention Type DRUG

One injection will be performed via hysteroscopy under local anesthesia.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One injection will be performed via hysteroscopy under local anesthesia.

Interventions

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Xeomin

One injection will be performed via hysteroscopy under local anesthesia.

Intervention Type DRUG

Placebo

One injection will be performed via hysteroscopy under local anesthesia.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult women who are not menopausal,
* Experiencing severe dysmenorrhea, defined as an average pain intensity score ≥ 6/10 on a Numerical Rating Scale (NRS) over the past 3 months at the inclusion visit,
* 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 6 months prior to the inclusion 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.

Exclusion Criteria

* Pregnant or planning a pregnancy during the entire study period,
* Currently breastfeeding,
* Refusal to use effective contraception during the study and for 6 months after its completion,
* Contraindications to botulinum toxin, including:
* Generalized disorders of muscular activity (e.g., myasthenia gravis, Lambert-Eaton syndrome),
* Ongoing treatment with aminoglycosides, peripheral muscle relaxants, or amino-4-quinolines,
* Hypersensitivity to the active substance, human albumin, or sucrose,
* Bleeding disorders or current treatment with anticoagulants,
* Ongoing vaginal or upper genital tract infection,
* Participation in another interventional clinical trial,
* Inability to cooperate or understand the study requirements in a way that would allow strict adherence to the protocol,
* Subject to legal protection measures (e.g., guardianship, curatorship, or judicial protection),
* Not affiliated with the French social security system,
* Unable to access the internet to complete questionnaires at Month 1 and Month 6.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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