EndometriosisPHAMEDENDONCT03994432
Effect of Mediterranean Diet and Physical Activity in Patients With Endometriosis
A study testing intervention group in people with Endometriosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The main aim of this study is to evaluate whether a dietary recommendation based on the Mediterranean diet's principles associated with a regular aerobic physical activity, according to the "7 minutes workout", may improve pain symptoms in patients with symptomatic endometriosis (pelvic pain with numerical rating… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2019to 20 Nov 2023
- 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
- age between 18 and 45 years
- body mass index between 18 and 29.9
- women with symptomatic endometriosis (pelvic pain with NRS score ≥ 4), in therapy with estro-progestins or progestins
- not seeking conception
Who cannot join
- associated diseases that cause pelvic pain regardless of the presence of endometriosis, or chronic intestinal diseases (Crohn's disease or ulcerative rectocolitis).
- patients in note for all kind of surgery
- women who conduct a strong physical activity.
- women who follow vegetarian-vegan diet regimens.
- metabolic diseases that require specific dietary indications (diabetes and celiac disease, food allergies).
- medical contraindications to proposed physical activity.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Laura Buggio Centro Endometriosi e Metrorragie Clinica Mangiagalli, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: Effect of Mediterranean Diet and Physical Activity in Patients With Symptomatic Endometriosis in Therapy With Estrogen-progestins or Progestins: a Randomized Controlled Trial
The main aim of this study is to evaluate whether a dietary recommendation based on the Mediterranean diet's principles associated with a regular aerobic physical activity, according to the "7 minutes workout", may improve pain symptoms in patients with symptomatic endometriosis (pelvic pain with numerical rating scale, NRS ≥ 4), in therapy with estrogen-progestins or progestins.
Read the detailed description
Endometriosis is an estrogen-dependent inflammatory disease, affecting almost 5% of the female population during the reproductive period. The most common symptom of women with endometriosis is dysmenorrhea. Nowadays, the main therapy is pharmacological treatment (estrogen-progestins and progestins); diet and physical exercises may represent a complementary and feasible approach to reduce the pain symptoms related to this disease.
Indeed, diet may be involved in several pathophysiological mechanisms linked to endometriosis, due to its ability to influence positively or negatively prostaglandins' metabolism, chronic inflammatory processes and circulating estrogen levels.
Among the various dietary regimes, the Mediterranean diet shows many anti-inflammatory and anti-oxidant properties.
Also regular physical activity can affect positively endometriosis, due to various etiopathogenetic mechanisms including the decrease of estrogenic levels and ovulatory frequency, the increase in SHBG levels, and the modulation of cytokines in an anti-inflammatory way.
One of the reasons of low regular physical activity is the lack of free time. For this reason, the American College of Sports Medicine developed a program designed for most of the population, called "7-minutes workout". It consists in 12 high-intensity physical exercises, lasting 30 seconds each and spaced out 10 seconds of short breaks, to be performed 2-3 times a week.
Currently, there are few studies evaluating the impact of regular physical activity and Mediterranean diet regimen on endometriosis.
The objective of this randomized controlled trial is to evaluate the potential beneficial impact of regular aerobic physical activity and Mediterranean diet on endometriosis pain symptoms.
Eligible women will be selected among those attending the Endometriosis Clinic of the "L. Mangiagalli ", IRCCS Ca 'Granda Foundation and Ospedale Maggiore Policlinico, and will be randomized into two homogeneous groups ("intervention" and "control") with a 1:1 ratio, according to the type of therapy: estro-progestins or progestins.
The "intervention" group will be composed of women with symptomatic endometriosis in estro-progestins or only progestin therapy, who will be asked to follow a Mediterranean diet and to practice a regular exercise program according to the "7-minutes workout" model. The "control" group will be composed of women with symptomatic endometriosis under therapy with estro-progestins or progestins who will continue to receive the routine clinical care.
All patients participating in the study will undergo clinical and ultrasonographic evaluation every fourth months. On these occasions, women will be routinely asked to complete some questionnaires, one on pain (a numerical rating scale, NRS), one on quality of life (the Short Form-12 questionnaire, SF-12), one on psychological status (the Hospital Anxiety and Depression scale, HADS), one on sexual functioning (theFemale Sexual Function Index, FSFI) and one on the global impression of change (Patients' Global Impression of Change scale, PGIC). Women will be also asked to rate the degree of satisfaction with their treatment. Moreover, at the beginning and at the end of the study all participants will be asked to complete a dietary questionnaire, a physical activity questionnaire (International Physical Activity Questionnaire, IPAQ) and a sleep quality questionnaire (The Pittsburgh Sleep Quality Index, PSQI).
Only the patients in the "intervention" group will be asked to follow a Mediterranean diet. They will receive a nutritional counseling with the investigator's hospital dietician periodically. Furthermore, these patients will follow an aerobic physical activity program 2-3 times a week for one year.
- Conditions
- Endometriosis
- Being tested
- intervention group
- Keywords
- mediterranean diet, endometriosis, physical activity, 7 minutes work-out
- Medical subject headings
- Endometriosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention groupBehavioural
follow a mediterranean diet and practice a regular aerobic exercise according to the "7-minutes workout" model.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | patients with symptomatic endometriosis in therapy with estro-progestins or progestins, who will be asked to follow a mediterranean diet and to practice an aerobic physical exercise according to the "7-minutes workout" model Receives: Behavioral: intervention group |
| Control group | No intervention | patients with symptomatic endometriosis in therapy with estro-progestins or progestins. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic pain changes in patients with endometriosis who follow a mediterranean diet and a regular physical activity
The presence and severity of dysmenorrhea, deep dyspareunia, and non-menstrual pelvic pain will be assessed using an 11-point numeric rating scale (NRS), with 0 indicating absence of pain and 10 pain as bad as it could be. Scores 1 to 4 will be considered mild pain, 5 to 7 moderate pain, and 8 to 10 severe pain. Patients will be considered for enrollment if they complained of at least moderate or severe pelvic pain (NRS score ≥ 4).
Measured: 12 months
Secondary outcomes (5)
The degree of satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity
Patients will rate the degree of satisfaction with their treatment according to a five-category scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).
Measured: 12 months
Changes in state of anxiety and depression in patients with endometriosis who follow a mediterranean diet and a regular physical activity
To determine states of anxiety and depression we'll use the Hospital Anxiety and Depression Scale (HADS) that is a self-assessment mood scale specifically designed for use in non-psychiatric hospital outpatients. It comprises 14 questions, 7 for the anxiety subscale and 7 for the depression subscale. Lower scores indicate better psychological status.
Measured: 12 months
Changes in sexual dysfunction and sexual satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity
We'll use the Female Sexual Function Index (FSFI) questionnaire that is a 19-item, multidimensional, self-report instrument for evaluating the main categories of female sexual dysfunction and sexual satisfaction. Domains include desire, arousal, lubrication, orgasm, satisfaction and pain. Each domain is scored on a scale of 1 to 5, and the maximum transformed full-scale score is 36, with a minimum full-scale score of 2.0. Women with a FSFI total score below 26.55 are categorized as experiencing sexual dysfunction
Measured: 12 months
Changes in quality of life in patients with endometriosis who follow a mediterranean diet and a regular physical activity.
Quality of life will be assessed with the Short-Form 12 (SF-12) health survey, developed from the original SF-36 questionnaire, a well-known, validated self-administered 12-item instrument. It measures health dimensions covering functional status, well-being, and overall health. Information from the 12 items is used to construct physical (PCS-12) and mental (MCS-12) component summary measures, with higher scores indicating better health perception.
Measured: 12 months
Changes in global improvement over time in patients with endometriosis who follow a mediterranean diet and a regular physical activity.
Overall improvement will be assessed by participants using the Patient Global Impression of Change scale, a 7-point categorical scale recommended for use in chronic pain studies as a core outcome measure of global improvement over time.According to this single-item rating system, the response during treatment is indicated by choosing one among seven alternative options, i.e., "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," and "very much worse."
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start10 Jan 2019
- Primary completion20 Jul 2020
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994432
- Sponsor's protocol ID
- 833_2018bis
- Acronym
- PHAMEDENDO
- Status last verified
- Jun 2025
- First submitted
- 25 Mar 2019
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Donati A, Giola F, Privitera G, Barbara G, Dridi D, Ottolini FL, Buggio L, Biciuffi R, Parazzini F, Chiaffarino F. Diet and physical activity coaching for well-being and pain reduction in patients with symptomatic endometriosis: a randomized-controlled clinical trial. Eur J Obstet Gynecol Reprod Biol. 2026 Aug 17;326:115381. doi: 10.1016/j.ejogrb.2026.115381. Online ahead of print.
PubMed 42632337
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mediterranean Diet and Physical Activity in Patients With Symptomatic Endometriosis in Therapy With Estrogen-progestins or Progestins: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03994432
- Acronym / sponsor ID
- PHAMEDENDO / 833_2018bis
- Conditions
- Endometriosis
- Keywords
- mediterranean diet, endometriosis, physical activity, 7 minutes work-out
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 21 Jun 2019 (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.
The main aim of this study is to evaluate whether a dietary recommendation based on the Mediterranean diet's principles associated with a regular aerobic physical activity, according to the "7 minutes workout", may improve pain symptoms in patients with symptomatic endometriosis (pelvic pain with numerical rating scale, NRS ≥ 4), in therapy with estrogen-progestins or progestins.
Detailed description
Endometriosis is an estrogen-dependent inflammatory disease, affecting almost 5% of the female population during the reproductive period. The most common symptom of women with endometriosis is dysmenorrhea. Nowadays, the main therapy is pharmacological treatment (estrogen-progestins and progestins); diet and physical exercises may represent a complementary and feasible approach to reduce the pain symptoms related to this disease.
Indeed, diet may be involved in several pathophysiological mechanisms linked to endometriosis, due to its ability to influence positively or negatively prostaglandins' metabolism, chronic inflammatory processes and circulating estrogen levels.
Among the various dietary regimes, the Mediterranean diet shows many anti-inflammatory and anti-oxidant properties.
Also regular physical activity can affect positively endometriosis, due to various etiopathogenetic mechanisms including the decrease of estrogenic levels and ovulatory frequency, the increase in SHBG levels, and the modulation of cytokines in an anti-inflammatory way.
One of the reasons of low regular physical activity is the lack of free time. For this reason, the American College of Sports Medicine developed a program designed for most of the population, called "7-minutes workout". It consists in 12 high-intensity physical exercises, lasting 30 seconds each and spaced out 10 seconds of short breaks, to be performed 2-3 times a week.
Currently, there are few studies evaluating the impact of regular physical activity and Mediterranean diet regimen on endometriosis.
The objective of this randomized controlled trial is to evaluate the potential beneficial impact of regular aerobic physical activity and Mediterranean diet on endometriosis pain symptoms.
Eligible women will be selected among those attending the Endometriosis Clinic of the "L. Mangiagalli ", IRCCS Ca 'Granda Foundation and Ospedale Maggiore Policlinico, and will be randomized into two homogeneous groups ("intervention" and "control") with a 1:1 ratio, according to the type of therapy: estro-progestins or progestins.
The "intervention" group will be composed of women with symptomatic endometriosis in estro-progestins or only progestin therapy, who will be asked to follow a Mediterranean diet and to practice a regular exercise program according to the "7-minutes workout" model. The "control" group will be composed of women with symptomatic endometriosis under therapy with estro-progestins or progestins who will continue to receive the routine clinical care.
All patients participating in the study will undergo clinical and ultrasonographic evaluation every fourth months. On these occasions, women will be routinely asked to complete some questionnaires, one on pain (a numerical rating scale, NRS), one on quality of life (the Short Form-12 questionnaire, SF-12), one on psychological status (the Hospital Anxiety and Depression scale, HADS), one on sexual functioning (theFemale Sexual Function Index, FSFI) and one on the global impression of change (Patients' Global Impression of Change scale, PGIC). Women will be also asked to rate the degree of satisfaction with their treatment. Moreover, at the beginning and at the end of the study all participants will be asked to complete a dietary questionnaire, a physical activity questionnaire (International Physical Activity Questionnaire, IPAQ) and a sleep quality questionnaire (The Pittsburgh Sleep Quality Index, PSQI).
Only the patients in the "intervention" group will be asked to follow a Mediterranean diet. They will receive a nutritional counseling with the investigator's hospital dietician periodically. Furthermore, these patients will follow an aerobic physical activity program 2-3 times a week for one year.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: intervention grouppatients with symptomatic endometriosis in therapy with estro-progestins or progestins, who will be asked to follow a mediterranean diet and to practice an aerobic physical exercise according to the "7-minutes workout" model |
| Control group | No intervention | –patients with symptomatic endometriosis in therapy with estro-progestins or progestins. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age between 18 and 45 years
- body mass index between 18 and 29.9
- women with symptomatic endometriosis (pelvic pain with NRS score ≥ 4), in therapy with estro-progestins or progestins
- not seeking conception
Key exclusion criteria (6 listed)
- associated diseases that cause pelvic pain regardless of the presence of endometriosis, or chronic intestinal diseases (Crohn's disease or ulcerative rectocolitis).
- patients in note for all kind of surgery
- women who conduct a strong physical activity.
- women who follow vegetarian-vegan diet regimens.
- metabolic diseases that require specific dietary indications (diabetes and celiac disease, food allergies).
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 |
|---|---|---|
| intervention groupfollow a mediterranean diet and practice a regular aerobic exercise according to the "7-minutes workout" model. | Behavioural | Intervention group |
Primary outcome
Pelvic pain changes in patients with endometriosis who follow a mediterranean diet and a regular physical activity
Time frame: 12 months
The presence and severity of dysmenorrhea, deep dyspareunia, and non-menstrual pelvic pain will be assessed using an 11-point numeric rating scale (NRS), with 0 indicating absence of pain and 10 pain as bad as it could be. Scores 1 to 4 will be considered mild pain, 5 to 7 moderate pain, and 8 to 10 severe pain. Patients will be considered for enrollment if they complained of at least moderate or severe pelvic pain (NRS score ≥ 4).
5 secondary outcomes
The degree of satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity
Time frame: 12 months
Changes in state of anxiety and depression in patients with endometriosis who follow a mediterranean diet and a regular physical activity
Time frame: 12 months
Changes in sexual dysfunction and sexual satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity
Time frame: 12 months
Changes in quality of life in patients with endometriosis who follow a mediterranean diet and a regular physical activity.
Time frame: 12 months
Changes in global improvement over time in patients with endometriosis who follow a mediterranean diet and a regular physical activity.
Time frame: 12 months
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 9 Jul 2025.
- Derived from this study: PubMed 42632337Donati A, Giola F, Privitera G, Barbara G, Dridi D, Ottolini FL, Buggio L, Biciuffi R, Parazzini F, Chiaffarino F. Diet and physical activity coaching for well-being and pain reduction in patients with symptomatic endometriosis: a randomized-controlled clinical trial. Eur J Obstet Gynecol Reprod Biol. 2026 Aug 17;326:115381. doi: 10.1016/j.ejogrb.2026.115381. Online ahead of print.
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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?
A study testing intervention group in people with Endometriosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 4 inclusion and 6 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 9 Jul 2025. 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 Italy. 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?
Pelvic pain changes in patients with endometriosis who follow a mediterranean diet and a regular physical activity (time frame: 12 months). 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 NCT03994432, which also lists 1 linked publication.
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 9 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.