Primary DysmenorrheaTENS-DYSNCT07521553
TENS for Primary Dysmenorrhea
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Primary Dysmenorrhea and Menstrual Pain, run by Centro Universitario La Salle at 1 site in Spain.
Trial summary
Primary dysmenorrhea is a common gynecological condition characterized by recurrent menstrual pain in the absence of pelvic pathology. It affects a large proportion of women of reproductive age and may significantly interfere with daily activities, academic performance, and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Primary Dysmenorrhea, Menstrual Pain, Dysmenorrhea
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 20 Dec 2019
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with primary dysmenorrhea
- History of recurrent menstrual pain without identifiable pelvic pathology
- Regular menstrual cycles
- Age between 18 and 45 years old
- Pain intensity of at least 4 on a 10-cm Visual Analogue Scale (VAS)
- Willingness to participate in the study and to comply with study procedures
- Provision of written informed consent
Who cannot join
- Secondary dysmenorrhea associated with identifiable pelvic pathology
- Pregnancy
- Irregular menstrual cycles
- Use of hormonal contraceptives initiated or modified during the study period
- Presence of gynecological or systemic conditions that could influence menstrual pain
- Contraindications to transcutaneous electrical nerve stimulation (TENS), such as pacemaker implantation or skin lesions at the electrode placement site
- Inability to understand study procedures or complete study questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Portable Transcutaneous Electrical Nerve Stimulation on Pain Intensity in Women With Primary Dysmenorrhea: A Randomized Controlled Pilot Study
Primary dysmenorrhea is a common gynecological condition characterized by recurrent menstrual pain in the absence of pelvic pathology. It affects a large proportion of women of reproductive age and may significantly interfere with daily activities, academic performance, and quality of life. Although pharmacological treatments such as nonsteroidal anti-inflammatory drugs are frequently used to manage menstrual pain, some women experience insufficient relief or prefer non-pharmacological treatment options.
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electrotherapy technique widely used in pain management. TENS is thought to reduce pain through mechanisms including modulation of nociceptive transmission at the spinal cord level and activation of endogenous analgesic pathways. Portable TENS devices may provide a convenient and accessible option for self-management of menstrual pain.
Read more
The aim of this randomized controlled pilot study was to evaluate the effectiveness of a portable TENS device in reducing pain intensity in women with primary dysmenorrhea. Participants diagnosed with primary dysmenorrhea were randomly assigned to either an intervention group receiving treatment with a portable TENS device or a control group receiving usual care.
The intervention consisted of the application of a portable TENS patch to the lower abdominal region during menstrual pain episodes. The device delivered alternating stimulation cycles combining high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). Each treatment session lasted approximately 20 minutes and was applied during menstrual pain episodes.
Participants were followed for up to three menstrual cycles. Pain intensity was assessed using a visual analogue scale (VAS). Additional outcomes included quality of life assessed using the Short Form-12 Health Survey (SF-12), anxiety and depression measured with the Hospital Anxiety and Depression Scale (HADS), female sexual function evaluated with the Female Sexual Function questionnaire (FSM), and analgesic medication use recorded in a pain diary.
The results of this study aim to contribute to the evidence on non-pharmacological interventions for menstrual pain and to evaluate the potential role of portable TENS devices as a safe and accessible option for women with primary dysmenorrhea.
Read the detailed description
Primary dysmenorrhea is a common gynecological condition characterized by recurrent menstrual pain in the absence of identifiable pelvic pathology. It affects a substantial proportion of women of reproductive age and is frequently associated with symptoms such as abdominal cramps, low back pain, nausea, fatigue, and headache. The condition may negatively affect daily functioning, academic performance, and quality of life. Despite its high prevalence, many women continue to experience inadequate pain control or adverse effects from pharmacological treatments.
Menstrual pain in primary dysmenorrhea is primarily associated with increased production of prostaglandins in the endometrium during menstruation. Elevated prostaglandin levels increase uterine contractility and vasoconstriction, which can result in uterine ischemia and activation of nociceptive pathways. These mechanisms contribute to the characteristic cramping pain experienced during menstruation.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used as first-line pharmacological treatment because they inhibit prostaglandin synthesis. However, some women experience insufficient pain relief, contraindications, or adverse effects associated with pharmacological therapies. For this reason, there is growing interest in non-pharmacological approaches to the management of primary dysmenorrhea.
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electrotherapy modality widely used for pain management in various clinical conditions. TENS delivers low-voltage electrical currents through electrodes placed on the skin, stimulating peripheral nerves. The analgesic effect of TENS is thought to be mediated by several physiological mechanisms, including activation of large-diameter afferent fibers that inhibit nociceptive transmission at the spinal cord level (gate control mechanism), as well as activation of descending inhibitory pathways and endogenous opioid release.
Several studies have suggested that TENS may reduce pain intensity in women with primary dysmenorrhea. In addition, portable TENS devices allow self-administration of therapy and may represent a convenient and accessible strategy for managing menstrual pain outside of clinical settings.
The aim of this randomized controlled pilot study was to evaluate the effectiveness of a portable transcutaneous electrical nerve stimulation device in reducing pain intensity in women with primary dysmenorrhea.
Participants diagnosed with primary dysmenorrhea were recruited and randomly allocated to one of two groups: an intervention group receiving portable TENS therapy or a control group receiving usual care. Randomization was performed using a simple allocation procedure to assign participants to either group.
Participants in the intervention group used a portable TENS device applied to the lower abdominal region during menstrual pain episodes. The device delivered alternating stimulation cycles combining high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). This combination of stimulation parameters was selected to potentially activate both segmental analgesic mechanisms and endogenous opioid-mediated pathways.
Each treatment session lasted approximately 20 minutes and was applied during menstrual pain episodes. Participants were instructed on the correct placement and use of the device before beginning the study.
Participants in the control group continued their usual management strategies for menstrual pain, which typically consisted of analgesic medication taken as needed.
The study was conducted over two to three menstrual cycles. During this period, participants recorded their pain intensity and medication use. Pain intensity was assessed using a visual analogue scale (VAS), which is a widely used and validated tool for measuring subjective pain intensity.
Additional outcomes were assessed to explore the potential broader effects of the intervention. Quality of life was evaluated using the Short Form-12 Health Survey (SF-12). Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS). Female sexual function was evaluated using a validated questionnaire. Analgesic medication use was also recorded during the study period.
Data collected during the study were analyzed to compare pain intensity and other outcomes between the intervention and control groups across menstrual cycles. The results of this study are intended to contribute to the evidence regarding the effectiveness of portable TENS devices as a non-pharmacological intervention for primary dysmenorrhea.
The findings may help inform future research and support the development of non-invasive strategies to improve pain management and quality of life in women experiencing menstrual pain.
- Conditions
- Primary Dysmenorrhea, Menstrual Pain, Dysmenorrhea
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Primary Dysmenorrhea, Menstrual Pain, Transcutaneous Electrical Nerve Stimulation, Non-Pharmacological Treatment, Pain Management, Women's Health
- Medical subject headings
- Dysmenorrhea, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Participants received treatment with a portable transcutaneous electrical nerve stimulation (TENS) device applied to the lower abdominal region during episodes of menstrual pain. The device delivered alternating stimulation cycles combining high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). Each session lasted approximately 20 minutes, with stimulation intensity adjusted individually to a strong but comfortable sensory level. The intervention was self-administered during menstrual pain episodes across up to three consecutive menstrual cycles.
| Study group | Role | What they receive |
|---|---|---|
| TENS Intervention Group | Experimental | Portable transcutaneous electrical nerve stimulation (TENS) device applied to the lower abdominal region during menstrual pain episodes. The device delivered alternating cycles of high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). Each session lasted approximately 20 minutes, with intensity adjusted to a strong but comfortable sensory level. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Usual care control group | No intervention | Participants continued their usual care during menstrual pain episodes, including the use of analgesic medication if needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured using the Visual Analogue Scale (VAS)
Pain intensity associated with primary dysmenorrhea measured using a 10-cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable.
Measured: Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles
Secondary outcomes (4)
Health-related quality of life measured using the Short Form-12 Health Survey (SF-12)
Health-related quality of life assessed using the Short Form-12 Health Survey (SF-12), which evaluates physical and mental health components. Higher scores indicate better perceived health status.
Measured: Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles
Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS)
Psychological symptoms assessed using the Hospital Anxiety and Depression Scale (HADS), a validated questionnaire composed of two subscales measuring anxiety and depressive symptoms. Higher scores indicate greater levels of anxiety or depression.
Measured: Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles
Female sexual function assessed using the Female Sexual Function questionnaire (FSM)
Female sexual function assessed using the Female Sexual Function questionnaire (FSM), a validated instrument evaluating domains such as desire, arousal, lubrication, orgasm, satisfaction, and pain during sexual activity.
Measured: Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles
Analgesic medication use recorded during menstrual pain episodes
Use of analgesic medication recorded in a pain diary during menstrual pain episodes to monitor the need for pharmacological pain management.
Measured: Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jun 2019
- Primary completion1 Nov 2019
- Study completion20 Dec 2019
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to either an intervention group receiving transcutaneous electrical nerve stimulation (TENS) or a control group receiving usual care. The study used a parallel assignment design, with no crossover between groups. Participants remained in their allocated group throughout the study period. Outcomes were measured longitudinally at the end of each menstrual cycle (approximately 28 days per cycle), for up to three consecutive cycles.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Vicente Leon Hernandez, Centro Universitario La Salle
- Investigators
- Jose Vicente León Hernández, PhD, Principal investigator, CSEU La Salle, UAM (Madrid)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521553
- Sponsor's protocol ID
- CSEULS-PI-025/2019
- Acronym
- TENS-DYS
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available because the dataset contains sensitive health-related information and there is no established data-sharing plan for this study. Aggregate results will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Portable Transcutaneous Electrical Nerve Stimulation on Pain Intensity in Women With Primary Dysmenorrhea: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07521553
- Acronym / sponsor ID
- TENS-DYS / CSEULS-PI-025/2019
- Conditions
- Primary Dysmenorrhea, Menstrual Pain, Dysmenorrhea
- Keywords
- Primary Dysmenorrhea, Menstrual Pain, Transcutaneous Electrical Nerve Stimulation, Non-Pharmacological Treatment, Pain Management, Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 13 Apr 2026 (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.
Primary dysmenorrhea is a common gynecological condition characterized by recurrent menstrual pain in the absence of pelvic pathology. It affects a large proportion of women of reproductive age and may significantly interfere with daily activities, academic performance, and quality of life. Although pharmacological treatments such as nonsteroidal anti-inflammatory drugs are frequently used to manage menstrual pain, some women experience insufficient relief or prefer non-pharmacological treatment options.
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electrotherapy technique widely used in pain management. TENS is thought to reduce pain through mechanisms including modulation of nociceptive transmission at the spinal cord level and activation of endogenous analgesic pathways. Portable TENS devices may provide a convenient and accessible option for self-management of menstrual pain.
The aim of this randomized controlled pilot study was to evaluate the effectiveness of a portable TENS device in reducing pain intensity in women with primary dysmenorrhea. Participants diagnosed with primary dysmenorrhea were randomly assigned to either an intervention group receiving treatment with a portable TENS device or a control group receiving usual care.
The intervention consisted of the application of a portable TENS patch to the lower abdominal region during menstrual pain episodes. The device delivered alternating stimulation cycles combining high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). Each treatment session lasted approximately 20 minutes and was applied during menstrual pain episodes.
Participants were followed for up to three menstrual cycles. Pain intensity was assessed using a visual analogue scale (VAS). Additional outcomes included quality of life assessed using the Short Form-12 Health Survey (SF-12), anxiety and depression measured with the Hospital Anxiety and Depression Scale (HADS), female sexual function evaluated with the Female Sexual Function questionnaire (FSM), and analgesic medication use recorded in a pain diary.
The results of this study aim to contribute to the evidence on non-pharmacological interventions for menstrual pain and to evaluate the potential role of portable TENS devices as a safe and accessible option for women with primary dysmenorrhea.
Detailed description
Primary dysmenorrhea is a common gynecological condition characterized by recurrent menstrual pain in the absence of identifiable pelvic pathology. It affects a substantial proportion of women of reproductive age and is frequently associated with symptoms such as abdominal cramps, low back pain, nausea, fatigue, and headache. The condition may negatively affect daily functioning, academic performance, and quality of life. Despite its high prevalence, many women continue to experience inadequate pain control or adverse effects from pharmacological treatments.
Menstrual pain in primary dysmenorrhea is primarily associated with increased production of prostaglandins in the endometrium during menstruation. Elevated prostaglandin levels increase uterine contractility and vasoconstriction, which can result in uterine ischemia and activation of nociceptive pathways. These mechanisms contribute to the characteristic cramping pain experienced during menstruation.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used as first-line pharmacological treatment because they inhibit prostaglandin synthesis. However, some women experience insufficient pain relief, contraindications, or adverse effects associated with pharmacological therapies. For this reason, there is growing interest in non-pharmacological approaches to the management of primary dysmenorrhea.
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electrotherapy modality widely used for pain management in various clinical conditions. TENS delivers low-voltage electrical currents through electrodes placed on the skin, stimulating peripheral nerves. The analgesic effect of TENS is thought to be mediated by several physiological mechanisms, including activation of large-diameter afferent fibers that inhibit nociceptive transmission at the spinal cord level (gate control mechanism), as well as activation of descending inhibitory pathways and endogenous opioid release.
Several studies have suggested that TENS may reduce pain intensity in women with primary dysmenorrhea. In addition, portable TENS devices allow self-administration of therapy and may represent a convenient and accessible strategy for managing menstrual pain outside of clinical settings.
The aim of this randomized controlled pilot study was to evaluate the effectiveness of a portable transcutaneous electrical nerve stimulation device in reducing pain intensity in women with primary dysmenorrhea.
Participants diagnosed with primary dysmenorrhea were recruited and randomly allocated to one of two groups: an intervention group receiving portable TENS therapy or a control group receiving usual care. Randomization was performed using a simple allocation procedure to assign participants to either group.
Participants in the intervention group used a portable TENS device applied to the lower abdominal region during menstrual pain episodes. The device delivered alternating stimulation cycles combining high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). This combination of stimulation parameters was selected to potentially activate both segmental analgesic mechanisms and endogenous opioid-mediated pathways.
Each treatment session lasted approximately 20 minutes and was applied during menstrual pain episodes. Participants were instructed on the correct placement and use of the device before beginning the study.
Participants in the control group continued their usual management strategies for menstrual pain, which typically consisted of analgesic medication taken as needed.
The study was conducted over two to three menstrual cycles. During this period, participants recorded their pain intensity and medication use. Pain intensity was assessed using a visual analogue scale (VAS), which is a widely used and validated tool for measuring subjective pain intensity.
Additional outcomes were assessed to explore the potential broader effects of the intervention. Quality of life was evaluated using the Short Form-12 Health Survey (SF-12). Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS). Female sexual function was evaluated using a validated questionnaire. Analgesic medication use was also recorded during the study period.
Data collected during the study were analyzed to compare pain intensity and other outcomes between the intervention and control groups across menstrual cycles. The results of this study are intended to contribute to the evidence regarding the effectiveness of portable TENS devices as a non-pharmacological intervention for primary dysmenorrhea.
The findings may help inform future research and support the development of non-invasive strategies to improve pain management and quality of life in women experiencing menstrual pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either an intervention group receiving transcutaneous electrical nerve stimulation (TENS) or a control group receiving usual care. The study used a parallel assignment design, with no crossover between groups. Participants remained in their allocated group throughout the study period. Outcomes were measured longitudinally at the end of each menstrual cycle (approximately 28 days per cycle), for up to three consecutive cycles.
| Arm | Type | Receives |
|---|---|---|
| TENS Intervention Group | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Portable transcutaneous electrical nerve stimulation (TENS) device applied to the lower abdominal region during menstrual pain episodes. The device delivered alternating cycles of high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). Each session lasted approximately 20 minutes, with intensity adjusted to a strong but comfortable sensory level. |
| Usual care control group | No intervention | –Participants continued their usual care during menstrual pain episodes, including the use of analgesic medication if needed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women diagnosed with primary dysmenorrhea
- History of recurrent menstrual pain without identifiable pelvic pathology
- Regular menstrual cycles
- Age between 18 and 45 years old
- Pain intensity of at least 4 on a 10-cm Visual Analogue Scale (VAS)
Key exclusion criteria (7 listed)
- Secondary dysmenorrhea associated with identifiable pelvic pathology
- Pregnancy
- Irregular menstrual cycles
- Use of hormonal contraceptives initiated or modified during the study period
- Presence of gynecological or systemic conditions that could influence menstrual pain
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)Participants received treatment with a portable transcutaneous electrical nerve stimulation (TENS) device applied to the lower abdominal region during episodes of menstrual pain. The device delivered alternating stimulation cycles combining high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). Each session lasted approximately 20 minutes, with stimulation intensity adjusted individually to a strong but comfortable sensory level. The intervention was self-administered during menstrual pain episodes across up to three consecutive menstrual cycles. | Device | TENS Intervention Group |
Primary outcome
Pain intensity measured using the Visual Analogue Scale (VAS)
Time frame: Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles
Pain intensity associated with primary dysmenorrhea measured using a 10-cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable.
4 secondary outcomes
Health-related quality of life measured using the Short Form-12 Health Survey (SF-12)
Time frame: Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles
Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS)
Time frame: Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles
Female sexual function assessed using the Female Sexual Function questionnaire (FSM)
Time frame: Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles
Analgesic medication use recorded during menstrual pain episodes
Time frame: Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles
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 13 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available because the dataset contains sensitive health-related information and there is no established data-sharing plan for this study. Aggregate results will be reported in scientific publications.
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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.
Jose Vicente León Hernández, PhD principal investigator
CSEU La Salle, UAM (Madrid)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Primary Dysmenorrhea and Menstrual Pain, run by Centro Universitario La Salle at 1 site in Spain.
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 7 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 13 Apr 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. 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 intensity measured using the Visual Analogue Scale (VAS) (time frame: Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.