Primary DysmenorrheaPhase 3HYSTEROXINENCT06995287
Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Pelvic Pain Suggestive of Dysmenorrhea
A Phase 3 study testing Xeomin in people with Primary Dysmenorrhea and Chronic Pelvic Pain, run by Nantes University Hospital at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Dysmenorrhea, Chronic Pelvic Pain
- What is being tested?
- Xeomin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 8 sitesFrance
- Study dates
- 9 Feb 2026to 9 Sep 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
Clinique axium / Centre resilience
Aix-en-Provence
Christine LEVEQUE, 33 6 64 91 72 45, c.leveque.chir@gmail.com
- Recruiting
CHU Angers
Angers
Léa DELBOS, 33 2 41 35 64 92, Lea.Delbos@chu-angers.fr
- Recruiting
CHU Brest
Brest
Christie REBAHI, 33 2 98 22 35 32, christie.rebahi@chu-brest.fr
- Recruiting
CHU Lille
Lille
Victoire DELPORTE, 33 3 20 44 66 41, Victoire.DELPORTE@chu-lille.fr
- Recruiting
Hôpital de la Croix-Rousse
Lyon
Gil DUBERNARD, 33 4 72 07 28 66, gil.dubernard@chu-lyon.fr
- Recruiting
CHU Nantes
Nantes
Claire CARDAILLAC, +33 2 53 48 23 50, claire.cardaillac@chu-nantes.fr
- Recruiting
Clinique Brétéché
Nantes
Pascal CALMELET, +33 2 51 86 88 13, pcalmelet.pro@gmail.com
- Not yet recruiting
CHU Rennes
Rennes
Krystel NYANGOH-TIMOH, 33 6 72 13 60 50, Krystel.NYANGOH.TIMOH@chu-rennes.fr
About this study
Official title: 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.
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.
Read the detailed description
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
- Primary Dysmenorrhea, Chronic Pelvic Pain
- Being tested
- Xeomin, Placebo
- Keywords
- Primary dysmenorrhea, injection, Botulimum toxin, Type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XeominDrug
One injection will be performed via hysteroscopy under local anesthesia.
PlaceboDrug
One injection will be performed via hysteroscopy under local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A | Experimental | 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. Receives: Drug: Xeomin |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Improvement
The response (favorable versus unfavorable) to the Patient Global Impression of Improvement questionnaire at 3 months following intra-myometrial injection. A response is considered favorable when the score of Patient Global Impression of Improvement questionnaire is 1 or 2. Patient Global Impression of Improvement questionnaire is self-assessment scale ranging from 1 (Very much improved) to 7 (Very much worsened).
Measured: 3 months
Secondary outcomes (67)
Average intensity of dysmenorrhea
Average intensity of dysmenorrhea evaluated using a numerical rating scale during the last menstrual cycle before injection, then at 3 and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
Maximum intensity of dysmenorrhea
Maximum intensity of dysmenorrhea evaluated using a numerical rating scale during the last menstrual cycle before injection, then at 3 and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
Duration of dysmenorrhea
Duration (in days) of dysmenorrhea during the last menstrual cycle before injection, then at 3 and 6 months.
Measured: 6 months
Average intensity of non-menstrual pelvic pain
Average intensity of non-menstrual pelvic pain evaluated using an numerical rating scale before injection, then at 1, 3, and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
Maximum intensity of non-menstrual pelvic pain
Maximum intensity of non-menstrual pelvic pain evaluated using an numerical rating scale before injection, then at 1, 3, and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
Duration of non-menstrual pelvic pain
Duration of non-menstrual pelvic pain (in days) evaluated before injection, then at 1, 3, and 6 months
Measured: 6 months
Average intensity of pain during the most recent sexual intercourse
Average intensity of pain during the most recent sexual intercourse, evaluated using an numerical rating scale before injection, then at 1, 3, and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
Sexual function assessed using the Female Sexual Function Index
Sexual function assessed using the Female Sexual Function Index before injection, and then at 1, 3, and 6 months. The Female Sexual Function Index consists of 19 items assessing six dimensions of female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm). The total score ranges from 2 to 36, with sexual dysfunction defined as a score below 23.
Measured: 6 months
Central sensitization to pain
Central sensitization to pain assessed using the Convergences PP score, before injection and at 3 months. The total Convergence PP score ranges from 0 to 10, with pelvic hypersensitivity defined as a score greater than or equal to 5.
Measured: 3 months
Heavy menstrual bleeding assessed using the Higham score
Heavy menstrual bleeding assessed using the Higham score during the last menstrual period, before injection, and at 3 and 6 months. The Higham score is an objective assessment score of menstrual blood loss. Each day of menstruation, the patiente counts the number of pads or tampons used, referring to a visual chart. A score above 100 points corresponds to a blood loss of 80 mL, which defines menorrhagia.
Measured: 6 months
General quality of life
General quality of life assessed using the The Short Form (36) Health Survey before injection, and at 1, 3, and 6 months. The questionnaire The Short Form (36) Health Survey is a multidimensional, generic scale, meaning it assesses health status regardless of the underlying condition, gender, age, or treatment. Its 36 items evaluate 8 domains: physical activity, physical role limitations, bodily pain, perceived health, vitality, social functioning, emotional state, and mental health. Each item is scored from 0 (lowest score) to 100 (highest score). At the end, a score for each SF-36 dimension is calculated based on the corresponding items, ranging from 0 (poor quality of life) to 100 (best quality of life).
Measured: 6 months
Disease-specific quality of life
Disease-specific quality of life assessed using the Endometriosis Health Profile EHP-5 questionnaire (it is the short version of Endometriosis Health Profile EHP-30) before injection, and at 1, 3, and 6 months. This short questionnaire includes only 11 out of 30 questions, to which patients must respond with Always, Often, Sometimes, Rarely, or Never. This questionnaire ranging from 0 (the best health status) to 44 (the worst health status).
Measured: 6 months
Number of days of school or work absenteeism
Number of days of school or work absenteeism in the past month, assessed before injection and at 1, 3, and 6 months.
Measured: 6 months
Anxiety assessed using the State and Tait Anxiety Inventoy-Y scale
Anxiety assessed using the State and Tait Anxiety Inventoy scale-Y before injection and at 3 months. This State and Tait Anxiety Inventoy scale-Y includes two distinct scales for assessing state anxiety (STAI Form Y-A) and trait anxiety (STAI Form Y-B). The Trait Anxiety scale consists of 20 items and assesses the individual's general tendency to experience anxiety. Scores range from 21 to 77.
The State Anxiety scale also includes 20 items and measures a temporary anxious mood (stress). Scores range from 20 to 80.
Measured: 3 months
Depression evaluated using the Beck Depression Inventory-II
Depression evaluated using the Beck Depression Inventory-II before injection and at 3 months. This is a self-administered questionnaire consisting of 21 items. Each item includes 4 statements corresponding to increasing levels of symptom intensity, rated on a scale from 0 to 3. The total score is obtained by summing the scores of the 21 items. The score can be interpreted according to the following four categories: no depression (score < 10); mild depression (10 < score < 18); moderate depression (19 < score < 29); and severe depression (score > 30).
Measured: 3 months
Global improvement percentage
Global improvement percentage (0-100%) assessed at 1, 3, and 6 months.
Measured: 6 months
Pain intensity during the procedure
Pain intensity during the procedure assessed via numerical rating scale. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: during procedure
Pain intensity at 5 minutes post-procedure
Pain intensity at 5 minutes post-procedure, assessed via numerical rating scale
Measured: 5 minutes post-procedure
Adverse events related to the injections
Adverse events related to the injections, recorded immediately postoperatively, and at 1, 3, and 6 months.
Measured: 6 months
Emergency visits following the procedure
Emergency visits following the procedure, assessed at 1 month.
Measured: 1 month
Exploratory analysis for the MEOPA subgroup : Primary Outcome
Exploratory analysis for the MEOPA subgroup: Primary outcome. The response (favorable versus unfavorable) to the Patient Global Impression of Improvement questionnaire at 3 months following intra-myometrial injection. A response is considered favorable when the score of Patient Global Impression of Improvement questionnaire is 1 or 2. Patient Global Impression of Improvement questionnaire is self-assessment scale ranging from 1 (Very much improved) to 7 (Very much worsened).
Measured: 3 months
Exploratory analysis for the MEOPA subgroup : Pain intensity during the procedure
Exploratory analysis for the MEOPA subgroup : procedural pain. Pain intensity during the procedure assessed via numerical rating scale. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: during procedure
Exploratory analysis for the MEOPA subgroup: Willingness to repeat the intervention
Exploratory analysis for the MEOPA subgroup: willingness to repeat the intervention. The response is rating Yes or No.
Measured: 6 months
Exploratory analysis for the MEOPA subgroup: Adverse event
Exploratory analysis for the MEOPA subgroup: adverse events.
Measured: 6 months
Exploratory analysis for the MEOPA subgroup : Emergency visits
Exploratory analysis for the MEOPA subgroup : emergency visits.
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Primary Outcome
Exploratory analysis for the hormonal treatment subgroup : Primary outcome. The response (favorable versus unfavorable) to the Patient Global Impression of Improvement questionnaire at 3 months following intra-myometrial injection. A response is considered favorable when the score of Patient Global Impression of Improvement questionnaire is 1 or 2. Patient Global Impression of Improvement questionnaire is self-assessment scale ranging from 1 (Very much improved) to 7 (Very much worsened).
Measured: 3 months
Exploratory analysis for the hormonal treatment subgroup : Pain intensity during the procedure
Exploratory analysis for the hormonal treatment subgroup : procedural pain. Pain intensity during the procedure assessed via numerical rating scale. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: during procedure
Exploratory analysis for the hormonal treatment subgroup : Adverse event
Exploratory analysis for the hormonal treatment subgroup : adverse events.
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Primary Outcome
For the exploratory analysis of subgroups of patients with and without amenorrhea : Primary outcome. The response (favorable versus unfavorable) to the Patient Global Impression of Improvement questionnaire at 3 months following intra-myometrial injection. A response is considered favorable when the score of Patient Global Impression of Improvement questionnaire is 1 or 2. Patient Global Impression of Improvement questionnaire is self-assessment scale ranging from 1 (Very much improved) to 7 (Very much worsened).
Measured: 3 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Average intensity of dysmenorrhea
For the exploratory analysis of subgroups of patients with and without amenorrhea: Average intensity of dysmenorrhea evaluated using a numerical rating scale during the last menstrual cycle before injection, then at 3 and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Emergency visits
Exploratory analysis for the hormonal treatment subgroup : emergency visits.
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Maximum intensity of dysmenorrhea
For the exploratory analysis of subgroups of patients with and without amenorrhea : Maximum intensity of dysmenorrhea evaluated using a numerical rating scale during the last menstrual cycle before injection, then at 3 and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Duration of dysmenorrhea
For the exploratory analysis of subgroups of patients with and without amenorrhea : Duration (in days) of dysmenorrhea during the last menstrual cycle before injection, then at 3 and 6 months.
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Average intensity of non-menstrual pelvic pain
For the exploratory analysis of subgroups of patients with and without amenorrhea : Average intensity of non-menstrual pelvic pain evaluated using an numerical rating scale before injection, then at 1, 3, and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Maximum intensity of non-menstrual pelvic pain
For the exploratory analysis of subgroups of patients with and without amenorrhea : Maximum intensity of non-menstrual pelvic pain evaluated using an numerical rating scale before injection, then at 1, 3, and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Duration of non-menstrual pelvic pain
For the exploratory analysis of subgroups of patients with and without amenorrhea : Duration of non-menstrual pelvic pain (in days) evaluated before injection, then at 1, 3, and 6 months
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Average intensity of pain during the most recent sexual intercourse
For the exploratory analysis of subgroups of patients with and without amenorrhea : Average intensity of pain during the most recent sexual intercourse, evaluated using an numerical rating scale before injection, then at 1, 3, and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Sexual function assessed using the Female Sexual Function Index
For the exploratory analysis of subgroups of patients with and without amenorrhea : Sexual function assessed using the Female Sexual Function Index before injection, and then at 1, 3, and 6 months. The Female Sexual Function Index consists of 19 items assessing six dimensions of female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm). The total score ranges from 2 to 36, with sexual dysfunction defined as a score below 23.
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Central sensitization to pain
For the exploratory analysis of subgroups of patients with and without amenorrhea : Central sensitization to pain assessed using the Convergences PP score, before injection and at 3 months. The total Convergence PP score ranges from 0 to 10, with pelvic hypersensitivity defined as a score greater than or equal to 5.
Measured: 3 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Heavy menstrual bleeding assessed using the Higham score
For the exploratory analysis of subgroups of patients with and without amenorrhea : Heavy menstrual bleeding assessed using the Higham score during the last menstrual period, before injection, and at 3 and 6 months. The Higham score is an objective assessment score of menstrual blood loss. Each day of menstruation, the patiente counts the number of pads or tampons used, referring to a visual chart. A score above 100 points corresponds to a blood loss of 80 mL, which defines menorrhagia.
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : General quality of life
For the exploratory analysis of subgroups of patients with and without amenorrhea : General quality of life assessed using the The Short Form (36) Health Survey before injection, and at 1, 3, and 6 months. The questionnaire The Short Form (36) Health Survey is a multidimensional, generic scale, meaning it assesses health status regardless of the underlying condition, gender, age, or treatment. Its 36 items evaluate 8 domains: physical activity, physical role limitations, bodily pain, perceived health, vitality, social functioning, emotional state, and mental health. Each item is scored from 0 (lowest score) to 100 (highest score). At the end, a score for each SF-36 dimension is calculated based on the corresponding items, ranging from 0 (poor quality of life) to 100 (best quality of life).
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Disease-specific quality of life
For the exploratory analysis of subgroups of patients with and without amenorrhea : Disease-specific quality of life assessed using the Endometriosis Health Profile EHP-5 questionnaire (it is the short version of Endometriosis Health Profile EHP-30) before injection, and at 1, 3, and 6 months. This short questionnaire includes only 11 out of 30 questions, to which patients must respond with Always, Often, Sometimes, Rarely, or Never. This questionnaire ranging from 0 (the best health status) to 44 (the worst health status).
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Number of days of school or work absenteeism
For the exploratory analysis of subgroups of patients with and without amenorrhea : Number of days of school or work absenteeism in the past month, assessed before injection and at 1, 3, and 6 months.
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Anxiety assessed using the State and Tait Anxiety Inventoy-Y scale
For the exploratory analysis of subgroups of patients with and without amenorrhea : Anxiety assessed using the State and Tait Anxiety Inventoy scale-Y before injection and at 3 months. This State and Tait Anxiety Inventoy scale-Y includes two distinct scales for assessing state anxiety (STAI Form Y-A) and trait anxiety (STAI Form Y-B). The Trait Anxiety scale consists of 20 items and assesses the individual's general tendency to experience anxiety. Scores range from 21 to 77.
The State Anxiety scale also includes 20 items and measures a temporary anxious mood (stress). Scores range from 20 to 80.
Measured: 3 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Depression evaluated using the Beck Depression Inventory-II
For the exploratory analysis of subgroups of patients with and without amenorrhea : Depression evaluated using the Beck Depression Inventory-II before injection and at 3 months. This is a self-administered questionnaire consisting of 21 items. Each item includes 4 statements corresponding to increasing levels of symptom intensity, rated on a scale from 0 to 3. The total score is obtained by summing the scores of the 21 items. The score can be interpreted according to the following four categories: no depression (score < 10); mild depression (10 < score < 18); moderate depression (19 < score < 29); and severe depression (score > 30).
Measured: 3 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Global improvement percentage
For the exploratory analysis of subgroups of patients with and without amenorrhea : Global improvement percentage (0-100%) assessed at 1, 3, and 6 months.
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Pain intensity during the procedure
For the exploratory analysis of subgroups of patients with and without amenorrhea : Pain intensity during the procedure assessed via numerical rating scale. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: during procedure
For the exploratory analysis of subgroups of patients with and without amenorrhea : Pain intensity at 5 minutes post-procedure
For the exploratory analysis of subgroups of patients with and without amenorrhea : Pain intensity at 5 minutes post-procedure, assessed via numerical rating scale
Measured: 5 minutes post-procedure
For the exploratory analysis of subgroups of patients with and without amenorrhea : Adverse events related to the injections
For the exploratory analysis of subgroups of patients with and without amenorrhea : Adverse events related to the injections, recorded immediately postoperatively, and at 1, 3, and 6 months.
Measured: 6 months
For the exploratory analysis of subgroups of patients with and without amenorrhea : Emergency visits following the procedure
For the exploratory analysis of subgroups of patients with and without amenorrhea : Emergency visits following the procedure, assessed at 1 month.
Measured: 1 month
Exploratory analysis for the hormonal treatment subgroup : Average intensity of dysmenorrhea
Exploratory analysis for the hormonal treatment subgroup : Average intensity of dysmenorrhea evaluated using a numerical rating scale during the last menstrual cycle before injection, then at 3 and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Maximum intensity of dysmenorrhea
Exploratory analysis for the hormonal treatment subgroup : Maximum intensity of dysmenorrhea evaluated using a numerical rating scale during the last menstrual cycle before injection, then at 3 and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Duration of dysmenorrhea
Exploratory analysis for the hormonal treatment subgroup : Duration (in days) of dysmenorrhea during the last menstrual cycle before injection, then at 3 and 6 months.
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Average intensity of non-menstrual pelvic pain
Exploratory analysis for the hormonal treatment subgroup : Average intensity of non-menstrual pelvic pain evaluated using an numerical rating scale before injection, then at 1, 3, and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Maximum intensity of non-menstrual pelvic pain
Exploratory analysis for the hormonal treatment subgroup : Maximum intensity of non-menstrual pelvic pain evaluated using an numerical rating scale before injection, then at 1, 3, and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Duration of non-menstrual pelvic pain
Exploratory analysis for the hormonal treatment subgroup : Duration of non-menstrual pelvic pain (in days) evaluated before injection, then at 1, 3, and 6 months
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Average intensity of pain during the most recent sexual intercourse
Exploratory analysis for the hormonal treatment subgroup : Average intensity of pain during the most recent sexual intercourse, evaluated using an numerical rating scale before injection, then at 1, 3, and 6 months. Numerical rating scale is self-assessment scale ranging from 0 (no pain) to 10 (maximum imaginable pain).
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Sexual function assessed using the Female Sexual Function Index
Exploratory analysis for the hormonal treatment subgroup : Sexual function assessed using the Female Sexual Function Index before injection, and then at 1, 3, and 6 months. The Female Sexual Function Index consists of 19 items assessing six dimensions of female sexual function (desire, arousal, pain, lubrication, satisfaction, orgasm). The total score ranges from 2 to 36, with sexual dysfunction defined as a score below 23.
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Central sensitization to pain
Exploratory analysis for the hormonal treatment subgroup : Central sensitization to pain assessed using the Convergences PP score, before injection and at 3 months. The total Convergence PP score ranges from 0 to 10, with pelvic hypersensitivity defined as a score greater than or equal to 5.
Measured: 3 months
Exploratory analysis for the hormonal treatment subgroup : Heavy menstrual bleeding assessed using the Higham score
Exploratory analysis for the hormonal treatment subgroup : Heavy menstrual bleeding assessed using the Higham score during the last menstrual period, before injection, and at 3 and 6 months. The Higham score is an objective assessment score of menstrual blood loss. Each day of menstruation, the patiente counts the number of pads or tampons used, referring to a visual chart. A score above 100 points corresponds to a blood loss of 80 mL, which defines menorrhagia.
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : General quality of life
Exploratory analysis for the hormonal treatment subgroup : General quality of life assessed using the The Short Form (36) Health Survey before injection, and at 1, 3, and 6 months. The questionnaire The Short Form (36) Health Survey is a multidimensional, generic scale, meaning it assesses health status regardless of the underlying condition, gender, age, or treatment. Its 36 items evaluate 8 domains: physical activity, physical role limitations, bodily pain, perceived health, vitality, social functioning, emotional state, and mental health. Each item is scored from 0 (lowest score) to 100 (highest score). At the end, a score for each SF-36 dimension is calculated based on the corresponding items, ranging from 0 (poor quality of life) to 100 (best quality of life).
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Disease-specific quality of life
Exploratory analysis for the hormonal treatment subgroup : Disease-specific quality of life assessed using the Endometriosis Health Profile EHP-5 questionnaire (it is the short version of Endometriosis Health Profile EHP-30) before injection, and at 1, 3, and 6 months. This short questionnaire includes only 11 out of 30 questions, to which patients must respond with Always, Often, Sometimes, Rarely, or Never. This questionnaire ranging from 0 (the best health status) to 44 (the worst health status).
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Number of days of school or work absenteeism
Exploratory analysis for the hormonal treatment subgroup : Number of days of school or work absenteeism in the past month, assessed before injection and at 1, 3, and 6 months.
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Anxiety assessed using the State and Tait Anxiety Inventoy-Y scale
Exploratory analysis for the hormonal treatment subgroup : Anxiety assessed using the State and Tait Anxiety Inventoy scale-Y before injection and at 3 months. This State and Tait Anxiety Inventoy scale-Y includes two distinct scales for assessing state anxiety (STAI Form Y-A) and trait anxiety (STAI Form Y-B). The Trait Anxiety scale consists of 20 items and assesses the individual's general tendency to experience anxiety. Scores range from 21 to 77.
The State Anxiety scale also includes 20 items and measures a temporary anxious mood (stress). Scores range from 20 to 80.
Measured: 3 months
Exploratory analysis for the hormonal treatment subgroup : Depression evaluated using the Beck Depression Inventory-II
Exploratory analysis for the hormonal treatment subgroup : Depression evaluated using the Beck Depression Inventory-II before injection and at 3 months. This is a self-administered questionnaire consisting of 21 items. Each item includes 4 statements corresponding to increasing levels of symptom intensity, rated on a scale from 0 to 3. The total score is obtained by summing the scores of the 21 items. The score can be interpreted according to the following four categories: no depression (score < 10); mild depression (10 < score < 18); moderate depression (19 < score < 29); and severe depression (score > 30).
Measured: 3 months
Exploratory analysis for the hormonal treatment subgroup : Global improvement percentage
Exploratory analysis for the hormonal treatment subgroup : Global improvement percentage (0-100%) assessed at 1, 3, and 6 months.
Measured: 6 months
Exploratory analysis for the hormonal treatment subgroup : Pain intensity at 5 minutes post-procedure
Exploratory analysis for the hormonal treatment subgroup : Pain intensity at 5 minutes post-procedure, assessed via numerical rating scale
Measured: 5 minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start9 Feb 2026
- Primary completion9 Jun 2028 (estimated)
- Study completion9 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Pharmaceuticals GmbH, Ministry of Health, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995287
- Sponsor's protocol ID
- RC24_0428
- Other IDs
- 2025-520638-53-00, 2025
- Acronym
- HYSTEROXINE
- Status last verified
- Jul 2026
- First submitted
- 12 May 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided