Primary DysmenorrheaDysmenorrheaNCT06233786

The Effectivenes of Non-invasive Neuromodulation in Adult Women With Primary Dysmenorrhea, Through the TENS Stimulation at Different Times of Menstrual Cycle in Each Group

A study testing Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase and Transcutaneous Electrical Nerve Stimulation (TENS) during luteal phase in people with Primary Dysmenorrhea, run by Naiara Benítez Aramburu at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The effectiveness of non-invasive neuromodulation in adult women with primary dysmenorrhea, through the TENS stimulation at different times in each group: during the bleeding phase (G1), between days 1 and 3 of menstrual cycle, and in the luteal phase (GI2), between days 17 to 24 of menstrual cycle. Read more about this study

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Primary Dysmenorrhea
What is being tested?: Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase and Transcutaneous Electrical Nerve Stimulation (TENS) during luteal phase
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteSpain
Study dates: 22 Feb 2024to 23 Sep 2026
Phase: Interventional
Are there results?: None posted in the registry

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 to 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

Adult women
Pain greater than 3 on the NPRS scale
Women with regular menstrual cycle, considered regular between 25-30 days

Who cannot join

Pregnancy or breastfeeding
Used of intrauterine device
Diagnosed gynaecological pathology: endometriosis, polycystic ovaries, uterine fibroid, adenomyosis, fibrosis, uterine malformation, pelvic inflammation, scars, SDT...
Skin lesions that prevent the placement of the electrodes
Other diagnosed pathologies that contraindicate the application of TENS, neurological pathologies, or cardiovascular diseases
Absence or doubling of bleeding in one month
Taking analgesic medications and/or NSAIDs

Trial locations and contacts

1 site in 1 country.

Spain1 site

Naiara Benítez Aramburu
Torrelavega, Cantabria, 39300

Other trials in Spain

About this study

Official title: Effectiveness of Non-invasive Neuromodulation in Primary Dysmenhorrea: A Randomized Clinical Trial

The control group (CG) will be treated just like GI1, during the bleeding phase, but without the TENS transmitting the current. Participants will be evaluated by the NPRS, MPQ, SF12, CVM-22, HADS, PCS, PSQI and UDP in the first day of menstruation. Aditionally, GI1 and GC women, will be evaluated inmediatelly after the first sesion of treatment.

Read the detailed description

This RCT will evaluate women of legal age, with pain greater than 3 on the NPRS scale, and whose menstrual cycle is regular, considered regular between 25-30 days. The sample will be divided into a cases group, which in turn will be divided into 2 subgroups: stimulation intervention in women with dysmenorrhea during the bleeding phase (GI1), and in the luteal phase (GI2). On the other hand, the control group (CG) will be treated just like GI1, during the bleeding phase, but without the transcutaneous electrical nerve stimulation (TENS) transmitting the current.

Initially, a screening questionnaire will be completed. Subsequently, a first assessment will be done to all included participants, which will be conducted by completing the Numerical Pain Scale (NPRS) in relation to their pain for 7 days, McGill Pain Questionnaire (MPQ), SF12 Health Survey, Specific Quality of life Questionnaire Related to Menstruation (CVM-22), Hospital Anxiety and Depression Scale (HADS) and Pain Catastrophizing Scale (PCS) and Pittsburgh Sleep Quality Index (PSQI), as well as pressure pain threshold measure (PPT).

Participants of G1 and GC group, will contact the researcher again to comunicate again the first day of bleeding of this second cycle to being evaluated that same day (without 24 hours passing). In this case, the scales, questionnaires and PPT are done before the intervention in order to observe possible changes from one cycle to another, so that it can be seen if the improvement achieved after treatment has been due to the treatment or other factors. Once the intervention in the bleeding phase is completed, only pain and PTT will be assessed. A second session will be done after 48 hour, but without any data being collected this time, and repeating the assessment on the first day of bleeding of the third cycle.

Regarding GI2, the two interventions sessions will be executed in the middle of the luteal phase, considering 21 days after the cycle start. They will be evaluated again on the first day of the bleeding of the second cycle, within 24 hours, which is estimated to be 7 days after the intervention.

GI1: TENS stimulation in the bleeding phase (days 1 and 3)
GI2: TENS stimulation in the follicular phase (days between 17 and 24)
GC: Same procedure as GI1, but without TENS stimulation.

This intervention is performed using a TENS with an asymmetric biphasic wave of 200 µs width, frequency of 100Hz and maximum intensity tolerated by the participant, adapting to avoid accommodation. The intervention will be carried out for 30 minutes, once a day, and 2 days a week, with 48-72 hours between both interventions. Regarding the electrodes, 4 adhesive electrodes (5.0x5.0) will be placed, 2 in the lower lumbar region and two in the parasacral region (S2-S4).

Conditions: Primary Dysmenorrhea
Being tested: Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase, Transcutaneous Electrical Nerve Stimulation (TENS) during luteal phase, Sham Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase
Keywords: Primary Dysmenorrhea, Transcutaneous Electrical Nerve Stimulation, Non-Invasive Neuromodulation, Sacral Surface Stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phaseDevice
Transcutaneous electrical nerve stimulation will be applied for 30 minutes on the first and third days of menstrual bleeding using a TENS device with 4 electrodes placed bilaterally along the midline of the lumbosacral region.
Transcutaneous Electrical Nerve Stimulation (TENS) during luteal phaseDevice
Transcutaneous electrical nerve stimulation will be applied for 30 minutes on cycle days 21 and 23, corresponding to the mid-luteal phase, using a TENS device with 4 electrodes placed bilaterally along the midline of the lumbosacral region.
Sham Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phaseDevice
The same procedure will be performed during the bleeding phase, but without delivering electrical current.

Study groups in NCT06233786
Study group	Role	What they receive
TENS in the bleeding phase	Experimental	Participants allocated to this arm will receive active TENS during the bleeding phase. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase
TENS in the luteal phase	Experimental	Participants allocated to this arm will receive active TENS during the luteal phase. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) during luteal phase
Sham TENS in the bleeding phase	Sham comparator	Participants allocated to this arm will receive sham TENS during the bleeding phase. Receives: Device: Sham Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phase

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain: Numerical Pain Scale (NPRS)
It evaluates the intensity of menstrual pain in this case. This scale is based on asking the patient about the intensity of their pain between a value of 0, which corresponds to the absence of pain, and a value of 10, which corresponds to the highest possible pain.
Measured: Pain intensity on the first day of menstrual bleeding will be assessed, in addition to the three days preceding and following it, across three consecutive cycles.
Pressure pain threshold (PDU): Analog pressure algometer (Wagner FPX, United States)
Pressure pain thresholds (PPTs) will be assessed in the abdominal and lumbar regions, corresponding to the usual areas of referred pain in women with dysmenorrhea. Five points will be evaluated in the lower abdominal region: two symmetrically located 4 cm from the umbilicus, two at the midpoint between the umbilicus and the anterior superior iliac spine, and one on the midline above the pubic symphysis (T10-T12). In the posterior region, the PPT will be measured at one point on the midline just below the last lumbar vertebra (L5), another at the central sacral level (S2-S4), and additionally at one point on the lateral wall of the right and left ischiorectal fossa.
Bilateral assessments will also be conducted at control sites: the temporal region, the lateral aspect of the arm 10 cm below the lateral border of the acromion (C6-C7), and the anterior aspect of the thigh 15 cm above the superior edge of the patella (L2-L3).
Measured: Assessments will be conducted on the first day of menstrual bleeding (within 24h) across three consecutive cycles. In the second cycle, both groups will undergo two assessments instead of one, carried out before and after the first treatment session.

Secondary outcomes (6)

Anxiety and Depresion: Hospital Anxiety and Depression Scale (HADS)
It is a 14-item self-administered questionnaire composed of two 7-item subscales: anxiety and depression. Each item is scored from 0 to 3, yielding subscale scores ranging from 0 to 21. Higher scores indicate greater symptom severity and a worse outcome of anxiety or depressive symptoms. The timeframe refers to the previous week.
Measured: Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.
Catastrophic thinking: Pain Catastrophizing Scale (PCS):
It is a self-report inventory that assesses pain catastrophizing, composed of 13 items, which are grouped into 3 factors, which are cognitive rumination, magnification, and hopelessness. Using a five-point Likert scale (0, not at all; 1, a little; 2, moderately; 3, a lot; and 4, all the time), the informant rates the intensity with which she has experienced each thought while experiencing pain. The higher the score, the greater the pain catastrophizing, which could be a total of 52 points.
Measured: Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.
Sleep quality: Pittsburgh Sleep Quality Index (PSQI):
It is a self-administered questionnaire that measures sleep quality, in addition to the subject's own perception of their sleep. It consists of 24 questions, of which 19 must be answered by the patient themselves (15 closed questions from 0 to 3, and 4 open), while 5 require feedback from the partner or roommate. The 19 self-assessed items are combined to form 7 scoring components (sleep quality, latency, duration, habitual efficiency, sleep disturbances, taking sleep medications, and daytime disturbances), each with a range of 0 to 3. A score of 0 points indicates that there is no difficulty, while a score of 3 corresponds to severe difficulty. The sum of the 7 components would give the global score, which has a range of 0 to 21 points, indicating severe difficulty in all the areas studied, as the score increase.
Measured: Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.
Quality of life: SF12 Health Questionnaire
It evaluates multidimensional health and it consists of 12 items (physical function, social function, physical role, emotional role, mental health, vitality, body pain and general health). It is a self-administered questionnaire, where the number of response options ranges between 2 and 6, among which the patient can only choose one. This questionnaire allows to obtain two scores, which correspond to the physical summary and the mental summary. A higher score is related to better health status.
Measured: Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.
Pain: McGill Pain Index (MPQ)
The McGill Pain Questionnaire (MPQ), developed by Melzack (1975), is a multidimensional tool with 78 descriptors across sensory, affective, evaluative, and miscellaneous dimensions. It characterizes pain quality and intensity through the Pain Rating Index (PRI) (0-78 total), Number of Words Chosen (NWC), and VAS (0-10). Higher PRI scores indicate greater pain severity.
Measured: Pain assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.
Quality of life related to menstruation: Specific quality of life questionnaire related to menstruation (CVM-22)
It assess the impact of menstruation on the woman's health status during bleeding days. The CVM-22 is a self-administered Likert-type questionnaire, made up of 22 items, where the questionnaire score ranges between 0 and 66, higher scores indicate worse quality of life.
Measured: Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 202423 Sep 2026

First posted31 Jan 2024
Study start22 Feb 2024
Primary completion13 Apr 2026
Study completion23 Sep 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (85)Papers the sponsor has linked to this study.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06233786
Sponsor's protocol ID: 2023.211
Acronym: Dysmenorrhea
Status last verified: Sep 2026
First submitted: 11 Jan 2024
Last updated: 28 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Iacovides S, Avidon I, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015 Nov-Dec;21(6):762-78. doi: 10.1093/humupd/dmv039. Epub 2015 Sep 7.
PubMed 26346058
Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.
PubMed 3461421
ACOG Committee Opinion No. 760: Dysmenorrhea and Endometriosis in the Adolescent. Obstet Gynecol. 2018 Dec;132(6):e249-e258. doi: 10.1097/AOG.0000000000002978.
PubMed 30461694
Coco AS. Primary dysmenorrhea. Am Fam Physician. 1999 Aug;60(2):489-96.
PubMed 10465224
Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.
PubMed 16690671
Osayande AS, Mehulic S. Diagnosis and initial management of dysmenorrhea. Am Fam Physician. 2014 Mar 1;89(5):341-6.
PubMed 24695505
Chen CX, Shieh C, Draucker CB, Carpenter JS. Reasons women do not seek health care for dysmenorrhea. J Clin Nurs. 2018 Jan;27(1-2):e301-e308. doi: 10.1111/jocn.13946. Epub 2017 Sep 7.
PubMed 28681499
Ramos-Pichardo JD, Ortega-Galan AM, Iglesias-Lopez MT, Abreu-Sanchez A, Fernandez-Martinez E. Why Do Some Spanish Nursing Students with Menstrual Pain Fail to Consult Healthcare Professionals? Int J Environ Res Public Health. 2020 Nov 5;17(21):8173. doi: 10.3390/ijerph17218173.
PubMed 33167417
Weissman AM, Hartz AJ, Hansen MD, Johnson SR. The natural history of primary dysmenorrhoea: a longitudinal study. BJOG. 2004 Apr;111(4):345-52. doi: 10.1111/j.1471-0528.2004.00090.x.
PubMed 15008771
Abreu-Sanchez A, Ruiz-Castillo J, Onieva-Zafra MD, Parra-Fernandez ML, Fernandez-Martinez E. Interference and Impact of Dysmenorrhea on the Life of Spanish Nursing Students. Int J Environ Res Public Health. 2020 Sep 5;17(18):6473. doi: 10.3390/ijerph17186473.
PubMed 32899505
Karout S, Soubra L, Rahme D, Karout L, Khojah HMJ, Itani R. Prevalence, risk factors, and management practices of primary dysmenorrhea among young females. BMC Womens Health. 2021 Nov 8;21(1):392. doi: 10.1186/s12905-021-01532-w.
PubMed 34749716
Dawood MY. Primary dysmenorrhea: advances in pathogenesis and management. Obstet Gynecol. 2006 Aug;108(2):428-41. doi: 10.1097/01.AOG.0000230214.26638.0c.
PubMed 16880317
Dawood MY. Dysmenorrhoea and prostaglandins: pharmacological and therapeutic considerations. Drugs. 1981 Jul;22(1):42-56. doi: 10.2165/00003495-198122010-00003.
PubMed 6790261
PICKLES VR. Myometrial responses to the menstrual plain muscle stimulant. J Endocrinol. 1959 Nov;19:150-7. doi: 10.1677/joe.0.0190150. No abstract available.
PubMed 14432762
Maybin JA, Critchley HO. Menstrual physiology: implications for endometrial pathology and beyond. Hum Reprod Update. 2015 Nov-Dec;21(6):748-61. doi: 10.1093/humupd/dmv038. Epub 2015 Aug 7.
PubMed 26253932

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Primary Dysmenorrhea trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Non-invasive Neuromodulation in Primary Dysmenhorrea: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT06233786
Acronym / sponsor ID: Dysmenorrhea / 2023.211
Conditions: Primary Dysmenorrhea
Keywords: Primary Dysmenorrhea, Transcutaneous Electrical Nerve Stimulation, Non-Invasive Neuromodulation, Sacral Surface Stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Naiara Benítez AramburuUniversity, hospital or other
Study start: 22 Feb 2024 (actual)
Primary completion: 13 Apr 2026 (actual)
Study completion: 23 Sep 2026 (actual)
First posted: 31 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

GI1: TENS stimulation in the bleeding phase (days 1 and 3)
GI2: TENS stimulation in the follicular phase (days between 17 and 24)
GC: Same procedure as GI1, but without TENS stimulation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
TENS in the bleeding phase	Experimental	Device: Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phaseParticipants allocated to this arm will receive active TENS during the bleeding phase.
TENS in the luteal phase	Experimental	Device: Transcutaneous Electrical Nerve Stimulation (TENS) during luteal phaseParticipants allocated to this arm will receive active TENS during the luteal phase.
Sham TENS in the bleeding phase	Sham comparator	Device: Sham Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phaseParticipants allocated to this arm will receive sham TENS during the bleeding phase.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Adult women
Pain greater than 3 on the NPRS scale
Women with regular menstrual cycle, considered regular between 25-30 days

Key exclusion criteria (7 listed)

Pregnancy or breastfeeding
Used of intrauterine device
Diagnosed gynaecological pathology: endometriosis, polycystic ovaries, uterine fibroid, adenomyosis, fibrosis, uterine malformation, pelvic inflammation, scars, SDT...
Skin lesions that prevent the placement of the electrodes
Other diagnosed pathologies that contraindicate the application of TENS, neurological pathologies, or cardiovascular diseases

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phaseTranscutaneous electrical nerve stimulation will be applied for 30 minutes on the first and third days of menstrual bleeding using a TENS device with 4 electrodes placed bilaterally along the midline of the lumbosacral region.	Device	TENS in the bleeding phase
Transcutaneous Electrical Nerve Stimulation (TENS) during luteal phaseTranscutaneous electrical nerve stimulation will be applied for 30 minutes on cycle days 21 and 23, corresponding to the mid-luteal phase, using a TENS device with 4 electrodes placed bilaterally along the midline of the lumbosacral region.	Device	TENS in the luteal phase
Sham Transcutaneous Electrical Nerve Stimulation (TENS) during bleeding phaseThe same procedure will be performed during the bleeding phase, but without delivering electrical current.	Device	Sham TENS in the bleeding phase

Primary outcome

Pain: Numerical Pain Scale (NPRS)
Time frame: Pain intensity on the first day of menstrual bleeding will be assessed, in addition to the three days preceding and following it, across three consecutive cycles.
It evaluates the intensity of menstrual pain in this case. This scale is based on asking the patient about the intensity of their pain between a value of 0, which corresponds to the absence of pain, and a value of 10, which corresponds to the highest possible pain.
Pressure pain threshold (PDU): Analog pressure algometer (Wagner FPX, United States)
Time frame: Assessments will be conducted on the first day of menstrual bleeding (within 24h) across three consecutive cycles. In the second cycle, both groups will undergo two assessments instead of one, carried out before and after the first treatment session.
Pressure pain thresholds (PPTs) will be assessed in the abdominal and lumbar regions, corresponding to the usual areas of referred pain in women with dysmenorrhea. Five points will be evaluated in the lower abdominal region: two symmetrically located 4 cm from the umbilicus, two at the midpoint between the umbilicus and the anterior superior iliac spine, and one on the midline above the pubic symphysis (T10-T12). In the posterior region, the PPT will be measured at one point on the midline just below the last lumbar vertebra (L5), another at the central sacral level (S2-S4), and additionally at one point on the lateral wall of the right and left ischiorectal fossa. Bilateral assessments will also be conducted at control sites: the temporal region, the lateral aspect of the arm 10 cm below the lateral border of the acromion (C6-C7), and the anterior aspect of the thigh 15 cm above the superior edge of the patella (L2-L3).

6 secondary outcomes

Anxiety and Depresion: Hospital Anxiety and Depression Scale (HADS)
Time frame: Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.
Catastrophic thinking: Pain Catastrophizing Scale (PCS):
Time frame: Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.
Sleep quality: Pittsburgh Sleep Quality Index (PSQI):
Time frame: Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.
Quality of life: SF12 Health Questionnaire
Time frame: Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.
Pain: McGill Pain Index (MPQ)
Time frame: Pain assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.
Quality of life related to menstruation: Specific quality of life questionnaire related to menstruation (CVM-22)
Time frame: Assessment using the scale will be conducted on the first day of menstrual bleeding during three consecutive cycles, together with the other scales.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Results publication: PubMed 26346058Iacovides S, Avidon I, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015 Nov-Dec;21(6):762-78. doi: 10.1093/humupd/dmv039. Epub 2015 Sep 7.
Results publication: PubMed 3461421Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.
Results publication: PubMed 30461694ACOG Committee Opinion No. 760: Dysmenorrhea and Endometriosis in the Adolescent. Obstet Gynecol. 2018 Dec;132(6):e249-e258. doi: 10.1097/AOG.0000000000002978.
Results publication: PubMed 10465224Coco AS. Primary dysmenorrhea. Am Fam Physician. 1999 Aug;60(2):489-96.
Results publication: PubMed 16690671Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.
Results publication: PubMed 24695505Osayande AS, Mehulic S. Diagnosis and initial management of dysmenorrhea. Am Fam Physician. 2014 Mar 1;89(5):341-6.
Results publication: PubMed 28681499Chen CX, Shieh C, Draucker CB, Carpenter JS. Reasons women do not seek health care for dysmenorrhea. J Clin Nurs. 2018 Jan;27(1-2):e301-e308. doi: 10.1111/jocn.13946. Epub 2017 Sep 7.
Results publication: PubMed 33167417Ramos-Pichardo JD, Ortega-Galan AM, Iglesias-Lopez MT, Abreu-Sanchez A, Fernandez-Martinez E. Why Do Some Spanish Nursing Students with Menstrual Pain Fail to Consult Healthcare Professionals? Int J Environ Res Public Health. 2020 Nov 5;17(21):8173. doi: 10.3390/ijerph17218173.
Results publication: PubMed 15008771Weissman AM, Hartz AJ, Hansen MD, Johnson SR. The natural history of primary dysmenorrhoea: a longitudinal study. BJOG. 2004 Apr;111(4):345-52. doi: 10.1111/j.1471-0528.2004.00090.x.
Results publication: PubMed 32899505Abreu-Sanchez A, Ruiz-Castillo J, Onieva-Zafra MD, Parra-Fernandez ML, Fernandez-Martinez E. Interference and Impact of Dysmenorrhea on the Life of Spanish Nursing Students. Int J Environ Res Public Health. 2020 Sep 5;17(18):6473. doi: 10.3390/ijerph17186473.
Results publication: PubMed 34749716Karout S, Soubra L, Rahme D, Karout L, Khojah HMJ, Itani R. Prevalence, risk factors, and management practices of primary dysmenorrhea among young females. BMC Womens Health. 2021 Nov 8;21(1):392. doi: 10.1186/s12905-021-01532-w.
Results publication: PubMed 16880317Dawood MY. Primary dysmenorrhea: advances in pathogenesis and management. Obstet Gynecol. 2006 Aug;108(2):428-41. doi: 10.1097/01.AOG.0000230214.26638.0c.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain: Numerical Pain Scale (NPRS) (time frame: Pain intensity on the first day of menstrual bleeding will be assessed, in addition to the three days preceding and following it, across three consecutive cycles.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06233786, which also lists 85 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.